{"schema":"lookcloser/record@0.2","compatible_with":["lookcloser/record@0.1"],"record_id":"853218000931","processing":{"collection_process_version":"2026-07-24.5","last_collected_at":"2026-08-20T10:19:22-0700","last_collection_event":"intake","label_reader_version":"legacy_unversioned","report_schema":"lookcloser/record@0.2","rendered_at":"2026-09-03T13:44:35-0700"},"analysis_status":"complete","processing_gaps":[],"gtin":"853218000931","listing_identifier":"B07M8P8TCZ","brand":"Ultima Replenisher","title":"Ultima Replenisher Daily Electrolyte Powder Drink Mix","listing_title":"Ultima Replenisher Daily Electrolyte Powder Drink Mix, 90-Serving Canister","identity":{"canonical_gtin":"00853218000931","source_listing_gtin":"00853218000931","listing_identifier":"B07M8P8TCZ","product_image":"https://m.media-amazon.com/images/I/61BgoSisFNL.jpg","product_image_status":"retained","product_image_provenance":{"status":"retained","source":"source_listing","identity_basis":"exact_listing_identifier","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","primary_url":"https://m.media-amazon.com/images/I/61BgoSisFNL.jpg","image_count":8,"last_attempted":"2026-08-20T10:19:22-0700","attempts":1},"observed_at":"2026-08-31","source_confirmations":["source_listing_gtin","external_barcode_record"],"brand_consistency":{"status":"unknown","compatible":null,"listing_brand":"Ultima Replenisher","package_brand":null,"match_method":"insufficient_text","similarity":null},"identity_rule":"exact identifiers only; related products are never substituted"},"trademark_owner":{"name":"Ultima Health Products, Inc.","entity":"CORPORATION","country":"Delaware, USA","address_filed":"4 Essex Avenue, Suite 303, Bernardsville, New Jersey 07924, UNITED STATES","address_public":"New Jersey 07924, UNITED STATES","serial_number":"99758176","registration_number":null,"wordmark":"ULTIMA REPLENISHER","status_description":"NEW APPLICATION - RECORD INITIALIZED NOT ASSIGNED TO EXAMINER","filed_date":"2026-04-11T00:00:00","first_use_commerce_date":"2021-06-30","registration_date":null,"assignment_recorded":false,"goods_services":["IC 005: Dietary beverage supplements for human consumption containing vitamins, minerals, and electrolytes; dietary supplement drink mixes; electrolyte replacement solutions."],"source":"USPTO Trademark Search","source_url":"https://tsdr.uspto.gov/#caseNumber=99758176&caseSearchType=US_APPLICATION&caseType=DEFAULT&searchType=statusSearch","identity_basis":"exact_wordmark_and_supplement_goods"},"trademark_owner_candidates":[],"trademark_owner_status":"found","product_manufacturer_link":"not_established","label_responsible_parties":[],"identity_nodes":[{"role":"trademark_owner","name":"Ultima Health Products, Inc.","country":"Delaware, USA","address":"4 Essex Avenue, Suite 303, Bernardsville, New Jersey 07924, UNITED STATES","source_ref":"uspto_search","identity_basis":"exact_wordmark_supplement_class"}],"seller_of_record":null,"seller_of_record_status":"not_collected_founder_gated","consumer_view":{"template":"identity_review","kicker":"The useful read","headline":"The barcode identity checks out · 853218000931.","deck":"The barcode matches, so we are checking the right product rather than a look-alike.","display_mode":"single_home_per_finding","finding_ids":["barcode-gtin-record-upc-independently-corroborated","uspto-trademark-registry-exact-trademark-owner-identified"],"point_finding_ids":["barcode-gtin-record-upc-independently-corroborated","uspto-trademark-registry-exact-trademark-owner-identified"],"cards":[{"finding_id":"barcode-gtin-record-upc-independently-corroborated","card_type":"upc_corroborated","question":"owner","tone":"ok","weight":48,"headline":"The barcode identity checks out · 853218000931.","evidence":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","so_what":"The barcode matches, so we are checking the right product rather than a look-alike.","source":"Barcode / GTIN record","source_links":[],"registry_receipts":[],"evidence_id":"ev-133cb82944d7","evidence_url":"https://lookcloser.ai/e/ev-133cb82944d7","presentation_home":"finding_catalog"},{"finding_id":"uspto-trademark-registry-exact-trademark-owner-identified","card_type":"owner_identified","question":"owner","tone":"neutral","weight":38,"headline":"🇺🇸 Brand owner: Ultima Health Products, Inc. · corporation, Delaware, USA","evidence":"USPTO lists Ultima Health Products, Inc. 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It does not by itself identify the manufacturer.","source":"USPTO trademark registry","source_links":[],"registry_receipts":[{"source":"uspto_search","url":"https://tsdr.uspto.gov/#caseNumber=99758176&caseSearchType=US_APPLICATION&caseType=DEFAULT&searchType=statusSearch","label":"USPTO · Serial 99758176","registry_name":"USPTO","standard":null,"identifier":"Serial 99758176"}],"evidence_id":"ev-db5ed0bae08d","evidence_url":"https://lookcloser.ai/e/ev-db5ed0bae08d","presentation_home":"ownership_section"}],"research_links":[{"ingredient":"magnesium","label":"NIH ODS — Magnesium fact sheet","url":"https://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/","scope":"ingredient_context","product_evidence":false},{"ingredient":"magnesium","label":"PubMed search: magnesium glycinate supplementation","url":"https://pubmed.ncbi.nlm.nih.gov/?term=magnesium+glycinate+supplementation","scope":"ingredient_context","product_evidence":false},{"ingredient":"zinc","label":"NIH ODS — Zinc fact sheet","url":"https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/","scope":"ingredient_context","product_evidence":false},{"ingredient":"zinc","label":"PubMed search: zinc supplementation trial","url":"https://pubmed.ncbi.nlm.nih.gov/?term=zinc+supplementation+randomized","scope":"ingredient_context","product_evidence":false}],"open_items":["No FDA recall matched this brand in the current search.","We have not found a public label filing for this exact product."]},"tldr":{"assessment":"checks_confirmed","headline":"UPC independently corroborated","summary":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","lead_finding_id":"barcode-gtin-record-upc-independently-corroborated","key_findings":[{"id":"uspto-trademark-registry-exact-trademark-owner-identified","class":"ok","headline":"Exact trademark owner identified","source":"USPTO trademark registry","scope":"brand_owner"},{"id":"barcode-gtin-record-upc-independently-corroborated","class":"ok","headline":"UPC independently corroborated","source":"Barcode / GTIN record","scope":"exact_product"}],"documented_concern_count":0,"confirmed_check_count":2,"open_question_count":1,"usage_note":"Decision support, not medical advice or a product recommendation. Missing evidence is a gap, not a strike."},"origin_context":null,"verdict":{"state":"checks_confirmed","headline":"UPC independently corroborated","detail":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","lead_finding_id":"barcode-gtin-record-upc-independently-corroborated","meaning":"Finding-first decision support. Confirmed checks are not endorsements; cautions identify documented facts or bounded comparisons, not medical advice."},"public_verifiability":{"state":"insufficient_public_data","headline":"This product can't be verified from public data","detail":"Neither good nor bad — the checks below show what this listing publishes and what it withholds. Verifiable products publish more.","meaning":"Evidence availability only. 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(CORPORATION) in Delaware, USA for the exact brand wordmark. This identifies the USPTO mark owner or applicant; it does not by itself prove who manufactures or sells this product.","source_refs":["uspto_search"],"source_records":[{"source":"uspto_search","source_url":"https://tsdr.uspto.gov/#caseNumber=99758176&caseSearchType=US_APPLICATION&caseType=DEFAULT&searchType=statusSearch","observed_at":"2026-08-31","identity_basis":"exact_wordmark_and_supplement_goods","scope":"brand","registry_name":"USPTO","identifier":"Serial 99758176","receipt_label":"USPTO · Serial 99758176"}],"observed_at":"2026-08-31","looked":"LookCloser checked USPTO trademark registry.","found":"USPTO lists Ultima Health Products, Inc. (CORPORATION) in Delaware, USA for the exact brand wordmark. This identifies the USPTO mark owner or applicant; it does not by itself prove who manufactures or sells this product."},"html_anchor":"finding-uspto-trademark-registry-exact-trademark-owner-identified","report_url":"https://lookcloser.ai/p/853218000931/full#finding-uspto-trademark-registry-exact-trademark-owner-identified"},{"id":"barcode-gtin-record-upc-independently-corroborated","source":"Barcode / GTIN record","class":"ok","noted":false,"severity":"ok","weight":38,"headline":"UPC independently corroborated","detail":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","proof":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","identity_basis":"gtin","status":"live","source_refs":["barcode_search","source_listing"],"source_url":"https://world.openfoodfacts.org/product/00853218000931","scope":"exact_product","inference_level":"direct_observation","observed_at":"2026-08-31","presentation_tone":"ok","evidence_id":"ev-133cb82944d7","evidence_url":"https://lookcloser.ai/e/ev-133cb82944d7","content_fingerprint":"sha256:8e76bfed56a2128d3d796fedd438b8794705e1107126c217ada947133a0c2075","registry_receipts":[],"evidence":{"summary":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","source_refs":["barcode_search","source_listing"],"source_records":[{"source":"barcode_search","source_url":"https://world.openfoodfacts.org/product/00853218000931","observed_at":"2026-08-31","identity_basis":"gtin","scope":"exact_gtin"},{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","looked":"LookCloser checked Barcode / GTIN record.","found":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing."},"html_anchor":"finding-barcode-gtin-record-upc-independently-corroborated","report_url":"https://lookcloser.ai/p/853218000931/full#finding-barcode-gtin-record-upc-independently-corroborated"},{"id":"label-and-serving-arithmetic-label-math-could-not-be-verified","source":"Label and serving arithmetic","class":"gap","noted":false,"severity":"pend","weight":26,"headline":"Label math could not be verified","detail":"The retained listing evidence does not establish net weight, unit count, per-serving dose, servings per container, so the dose claim cannot yet be checked against serving arithmetic. This is a neutral evidence gap, not a pass or strike.","proof":"The retained listing evidence does not establish net weight, unit count, per-serving dose, servings per container, so the dose claim cannot yet be checked against serving arithmetic. This is a neutral evidence gap, not a pass or strike.","identity_basis":"listing","status":"live","source_refs":["source_listing"],"source_url":"https://www.amazon.com/dp/B07M8P8TCZ","scope":"exact_listing","inference_level":"gap","observed_at":"2026-08-31","presentation_tone":"gap","evidence_id":"ev-d780d673d877","evidence_url":"https://lookcloser.ai/e/ev-d780d673d877","content_fingerprint":"sha256:c319776a041f55a0c58a44fe01d08ec014ce90918b3f8b3f607bab7b756b9798","registry_receipts":[],"evidence":{"summary":"The retained listing evidence does not establish net weight, unit count, per-serving dose, servings per container, so the dose claim cannot yet be checked against serving arithmetic. This is a neutral evidence gap, not a pass or strike.","source_refs":["source_listing"],"source_records":[{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","looked":"LookCloser checked Label and serving arithmetic.","found":"The retained listing evidence does not establish net weight, unit count, per-serving dose, servings per container, so the dose claim cannot yet be checked against serving arithmetic. This is a neutral evidence gap, not a pass or strike."},"html_anchor":"finding-label-and-serving-arithmetic-label-math-could-not-be-verified","report_url":"https://lookcloser.ai/p/853218000931/full#finding-label-and-serving-arithmetic-label-math-could-not-be-verified"},{"id":"label-and-serving-arithmetic-public-label-filing-not-retained","source":"Label and serving arithmetic","class":"gap","noted":false,"severity":"info","weight":19,"headline":"Public label filing not retained","detail":"We have not found a public label filing for this exact product. That is a gap in our records, not evidence that no filing exists.","proof":"We have not found a public label filing for this exact product. That is a gap in our records, not evidence that no filing exists.","identity_basis":"listing","status":"live","source_refs":["source_listing"],"source_url":"https://www.amazon.com/dp/B07M8P8TCZ","scope":"exact_listing","inference_level":"gap","observed_at":"2026-08-31","presentation_tone":"gap","evidence_id":"ev-07d62c91990b","evidence_url":"https://lookcloser.ai/e/ev-07d62c91990b","content_fingerprint":"sha256:dd9ec30f51afb750131ea31a7225c301598fc21a406bc5ed5e074379a66e8ba3","registry_receipts":[],"evidence":{"summary":"We have not found a public label filing for this exact product. That is a gap in our records, not evidence that no filing exists.","source_refs":["source_listing"],"source_records":[{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","looked":"LookCloser checked Label and serving arithmetic.","found":"We have not found a public label filing for this exact product. That is a gap in our records, not evidence that no filing exists."},"html_anchor":"finding-label-and-serving-arithmetic-public-label-filing-not-retained","report_url":"https://lookcloser.ai/p/853218000931/full#finding-label-and-serving-arithmetic-public-label-filing-not-retained"},{"id":"fda-public-records-recall-search-no-match-found-as-of-sep-03-2026","source":"FDA public records","class":"gap","noted":false,"severity":"info","weight":19,"headline":"Recall search: no match found (as of Sep 03, 2026)","detail":"This means only that no enforcement record matched the brand name — it does not mean the product was tested, reviewed, or cleared by FDA. New and untested products also have no recall records.","proof":"This means only that no enforcement record matched the brand name — it does not mean the product was tested, reviewed, or cleared by FDA. New and untested products also have no recall records.","identity_basis":"none","status":"live","source_refs":["openfda_search"],"source_url":"https://api.fda.gov/food/enforcement.json?search=(recalling_firm:%22Ultima+Replenisher%22+OR+product_description:%22Ultima+Replenisher%22)&limit=5","scope":"search_scope","inference_level":"gap","observed_at":"2026-08-31","presentation_tone":"caution","evidence_id":"ev-3dbfd10d77ce","evidence_url":"https://lookcloser.ai/e/ev-3dbfd10d77ce","content_fingerprint":"sha256:3039c936c5fdc801790369e4ae3d53975c8b3cbd426e50f803920803a4474a10","registry_receipts":[],"evidence":{"summary":"This means only that no enforcement record matched the brand name — it does not mean the product was tested, reviewed, or cleared by FDA. New and untested products also have no recall records.","source_refs":["openfda_search"],"source_records":[{"source":"openfda_search","source_url":"https://api.fda.gov/food/enforcement.json?search=(recalling_firm:%22Ultima+Replenisher%22+OR+product_description:%22Ultima+Replenisher%22)&limit=5","observed_at":"2026-08-31","identity_basis":"search_only","scope":"product_or_brand","registry_name":"FDA enforcement","identifier":"Ultima Replenisher","receipt_label":"FDA enforcement search · Ultima Replenisher"}],"observed_at":"2026-08-31","looked":"LookCloser checked FDA public records.","found":"This means only that no enforcement record matched the brand name — it does not mean the product was tested, reviewed, or cleared by FDA. New and untested products also have no recall records."},"html_anchor":"finding-fda-public-records-recall-search-no-match-found-as-of-sep-03-2026","report_url":"https://lookcloser.ai/p/853218000931/full#finding-fda-public-records-recall-search-no-match-found-as-of-sep-03-2026"},{"id":"keepa-exact-listing-history-this-item-belongs-to-a-catalog-variation-fam","source":"Keepa exact-listing history","class":"gap","noted":false,"severity":"info","weight":19,"headline":"This item belongs to a catalog variation family","detail":"The paid catalog links this exact item to a parent listing. Review counts on public product pages may be shared across sizes, flavors, or other variants, so the count history is listing context — not evidence that reviewers received or tested this exact variant.","proof":"The paid catalog links this exact item to a parent listing. Review counts on public product pages may be shared across sizes, flavors, or other variants, so the count history is listing context — not evidence that reviewers received or tested this exact variant.","identity_basis":"listing","status":"live","source_refs":["keepa_history","source_listing"],"source_url":"https://keepa.com/#!product/1-B07M8P8TCZ","scope":"exact_listing","inference_level":"gap","observed_at":"2026-08-31","presentation_tone":"gap","evidence_id":"ev-79300088d3cf","evidence_url":"https://lookcloser.ai/e/ev-79300088d3cf","content_fingerprint":"sha256:af764cd790ebec4f4506421aef64edd9d6e0cf649668aa939e12cb0c7665a66a","registry_receipts":[],"evidence":{"summary":"The paid catalog links this exact item to a parent listing. Review counts on public product pages may be shared across sizes, flavors, or other variants, so the count history is listing context — not evidence that reviewers received or tested this exact variant.","source_refs":["keepa_history","source_listing"],"source_records":[{"source":"keepa_history","source_url":"https://keepa.com/#!product/1-B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"exact_listing_identifier","scope":"exact_listing"},{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","looked":"LookCloser checked Keepa exact-listing history.","found":"The paid catalog links this exact item to a parent listing. Review counts on public product pages may be shared across sizes, flavors, or other variants, so the count history is listing context — not evidence that reviewers received or tested this exact variant."},"html_anchor":"finding-keepa-exact-listing-history-this-item-belongs-to-a-catalog-variation-fam","report_url":"https://lookcloser.ai/p/853218000931/full#finding-keepa-exact-listing-history-this-item-belongs-to-a-catalog-variation-fam"},{"id":"keepa-exact-listing-history-180-day-review-count-history-is-on-file","source":"Keepa exact-listing history","class":"gap","noted":false,"severity":"info","weight":16,"headline":"180-day review-count history is on file","detail":"Exact-listing history records written-review counts from 452 on 2025-08-03 to 640 on 2026-09-02 (net +188). Count movements can reflect sales, listing variants, collection resets, or moderation; this history does not establish whether reviews are authentic.","proof":"Exact-listing history records written-review counts from 452 on 2025-08-03 to 640 on 2026-09-02 (net +188). Count movements can reflect sales, listing variants, collection resets, or moderation; this history does not establish whether reviews are authentic.","identity_basis":"listing","status":"live","source_refs":["keepa_history","source_listing"],"source_url":"https://keepa.com/#!product/1-B07M8P8TCZ","scope":"exact_listing","inference_level":"gap","observed_at":"2026-08-31","presentation_tone":"gap","evidence_id":"ev-7276302fa39b","evidence_url":"https://lookcloser.ai/e/ev-7276302fa39b","content_fingerprint":"sha256:fa847f328d0a8dbb4ad2060738e3316bae2bfe5c832843b8b5e5bb662a5023ab","registry_receipts":[],"evidence":{"summary":"Exact-listing history records written-review counts from 452 on 2025-08-03 to 640 on 2026-09-02 (net +188). Count movements can reflect sales, listing variants, collection resets, or moderation; this history does not establish whether reviews are authentic.","source_refs":["keepa_history","source_listing"],"source_records":[{"source":"keepa_history","source_url":"https://keepa.com/#!product/1-B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"exact_listing_identifier","scope":"exact_listing"},{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","looked":"LookCloser checked Keepa exact-listing history.","found":"Exact-listing history records written-review counts from 452 on 2025-08-03 to 640 on 2026-09-02 (net +188). Count movements can reflect sales, listing variants, collection resets, or moderation; this history does not establish whether reviews are authentic."},"html_anchor":"finding-keepa-exact-listing-history-180-day-review-count-history-is-on-file","report_url":"https://lookcloser.ai/p/853218000931/full#finding-keepa-exact-listing-history-180-day-review-count-history-is-on-file"}],"evidence_records":[{"evidence_id":"ev-db5ed0bae08d","record_id":"853218000931","gtin":"853218000931","claim_key":"finding:uspto-trademark-registry-exact-trademark-owner-identified","primary_source":"uspto_search","claim":"Exact trademark owner identified","bucket":"checks_out","looked":"LookCloser checked USPTO trademark registry.","found":"USPTO lists Ultima Health Products, Inc. (CORPORATION) in Delaware, USA for the exact brand wordmark. This identifies the USPTO mark owner or applicant; it does not by itself prove who manufactures or sells this product.","proof":{"detail":"USPTO lists Ultima Health Products, Inc. (CORPORATION) in Delaware, USA for the exact brand wordmark. This identifies the USPTO mark owner or applicant; it does not by itself prove who manufactures or sells this product."},"source_refs":[{"source":"uspto_search","source_url":"https://tsdr.uspto.gov/#caseNumber=99758176&caseSearchType=US_APPLICATION&caseType=DEFAULT&searchType=statusSearch","observed_at":"2026-08-31","identity_basis":"exact_wordmark_and_supplement_goods","scope":"brand","registry_name":"USPTO","identifier":"Serial 99758176","receipt_label":"USPTO · Serial 99758176"}],"observed_at":"2026-08-31","content_fingerprint":"sha256:e95fc4c288c432f30ca4db9d50c2f3c2acb199ca03a2ac6a946c38b03a5b3fce","evidence_url":"https://lookcloser.ai/e/ev-db5ed0bae08d"},{"evidence_id":"ev-133cb82944d7","record_id":"853218000931","gtin":"853218000931","claim_key":"finding:barcode-gtin-record-upc-independently-corroborated","primary_source":"barcode_search","claim":"UPC independently corroborated","bucket":"checks_out","looked":"LookCloser checked Barcode / GTIN record.","found":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing.","proof":{"detail":"Open Food Facts resolves 853218000931 to \"Ultima Replenisher Pink Lemonade\" (Ultima Replenisher) — consistent with this listing."},"source_refs":[{"source":"barcode_search","source_url":"https://world.openfoodfacts.org/product/00853218000931","observed_at":"2026-08-31","identity_basis":"gtin","scope":"exact_gtin"},{"source":"source_listing","source_url":"https://www.amazon.com/dp/B07M8P8TCZ","observed_at":"2026-08-31","identity_basis":"listing_identifier","scope":"exact_listing"}],"observed_at":"2026-08-31","content_fingerprint":"sha256:8e76bfed56a2128d3d796fedd438b8794705e1107126c217ada947133a0c2075","evidence_url":"https://lookcloser.ai/e/ev-133cb82944d7"},{"evidence_id":"ev-3dbfd10d77ce","record_id":"853218000931","gtin":"853218000931","claim_key":"finding:fda-public-records-recall-search-no-match-found-as-of-sep-03-2026","primary_source":"openfda_search","claim":"Recall search: no match found (as of Sep 03, 2026)","bucket":"unverified","looked":"LookCloser checked FDA public records.","found":"This means only that no enforcement record matched the brand name — it does not mean the product was tested, reviewed, or cleared by FDA. 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