Home NDC 85237-1946 TYLENOL Extra Strength
Product NDC 85237-1946
11-digit product format 852371946
Labeler code 85237
Product ID 85237-1946_5543ed1a-4081-afdd-e063-6394a90aa77b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Select Consumer Group LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1984-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TYLENOL Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 14 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPE ACETAMINOPHEN DeMoulas Market Basket 0ff5c86e-d84b-42ad-b749-636ab2e3734e 2026-05-09 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN Rugby Laboratories 939fce7e-55df-4dc5-916b-a533448e962f 2026-05-08 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN Genexa Inc. f7e6e984-f0c3-ed40-e053-6294a90a89f7 2026-05-08 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. c59cbf0e-1381-4dd2-e053-2a95a90a853a 2026-05-08 Warnings Exact identifier application number: M013 Genexa Acetaminophen Extra Strength ACETAMINOPHEN Genexa Inc. d6f968ca-719f-5a68-e053-2995a90a4afa 2026-05-08 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN Genexa Inc. a7bd0b92-6f85-6175-e053-2995a90ab837 2026-05-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 816b65d7-e53f-44c4-a418-074279d4b2af 2026-05-08 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Amerisource Bergen 566dbd02-5e04-4461-8f5f-9fb58a42a375 2026-05-07 Warnings Exact identifier application number: M013 Back and Body Extra Strength ASPIRIN, CAFFEINE DOLGENCORP, LLC d4c0c81b-9176-47d0-a5e4-a584406078d9 2026-05-07 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Pinnacle RX LLC 513cf0e1-6874-9402-e063-6294a90aedc6 2026-05-07 Warnings Exact identifier application number: M013 Infants Pain and Fever Cherry Flavor ACETAMINOPHEN Genexa Inc. 19215ea7-d55f-8d81-e063-6294a90a4924 2026-05-07 Warnings Exact identifier application number: M013 up and up acetaminophen infants ACETAMINOPHEN Target Corporation c1dd8330-fb6b-4d1f-9484-c199dc69214d 2026-05-07 Warnings Exact identifier application number: M013 Extra Strength Aspirin ASPIRIN HHH Pharmaceuticals 90d457bb-79a7-4759-8ee7-6abffbe1e549 2026-05-06 Warnings Exact identifier application number: M013 Aspirin 81mg Enteric Coated ASPIRIN HHH Pharmaceuticals d81aec73-c7c1-4c52-80f6-fb0e32caf7aa 2026-05-06 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN HHH Pharmaceuticals 0c66b05d-132d-4c79-abfe-415fd68bbb9c 2026-05-06 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Better Living Brands, LLC 5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24 2026-05-06 Warnings Exact identifier application number: M013 Back and Body Extra Strength ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab 2026-05-06 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geiss, Destin & Dunn Inc. b8f6e486-5332-4c46-ab6c-7de04c91c60b 2026-05-06 Warnings Exact identifier application number: M013 MAX relief junior Grape CHILDRENS ACETAMINOPHEN ATLANTIC BIOLOGICALS CORP. c60494f0-5a50-41da-bcb4-88178ded54b7 2026-05-05 Warnings Exact identifier application number: M013 equate pain relief pm ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE WALMART INC. 85129749-c1a7-4c4a-933f-c3c4768e2cdd 2026-05-05 Warnings Exact identifier application number: M013
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85237-1946-1 85237194601 1 POUCH in 1 BLISTER PACK (85237-1946-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 1 pouch 2025-06-04 No No Current 85237-1946-2 85237194602 2 POUCH in 1 BLISTER PACK (85237-1946-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 2 pouch 2025-06-04 No No Current 85237-1946-3 85237194603 20 POUCH in 1 CARTON (85237-1946-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 20 pouch 2025-06-04 No No Current 85237-1946-4 85237194604 25 POUCH in 1 CARTON (85237-1946-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 25 pouch 2025-06-04 No No Current 85237-1946-5 85237194605 30 POUCH in 1 CARTON (85237-1946-5) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 30 pouch 2025-06-04 No No Current 85237-1946-6 85237194606 50 POUCH in 1 CARTON (85237-1946-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 50 pouch 2025-06-04 No No Current 85237-1946-7 85237194607 3 POUCH in 1 BLISTER PACK (85237-1946-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1946-0) 3 pouch 2025-06-04 No No Current