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 10 of 83 · 1,657 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 98c30922-c48c-471a-a72e-50020a11da98 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Mejoralito Children ACETAMINOPHEN OPMX LLC 5464188d-0137-033e-e063-6294a90ace66 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 DESENFRIOL-ITO PLUS ACETAMINOPHEN OPMX LLC 544ee7bd-0c95-2485-e063-6294a90a98c7 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE P & L Development, LLC 55e996cd-ef22-4e09-a05c-8aa994e4540b 2026-06-12 Warnings Exact identifier application number: M013 CHILDRENS TYLENOL ACETAMINOPHEN Kenvue Brands LLC 3162733b-9382-39f1-e063-6294a90ac420 2026-06-12 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 2026-06-12 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN NuCare Pharmaceuticals, Inc. 54010ddf-25d1-2016-e063-6294a90a877d 2026-06-11 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Preferred Pharmaceuticals Inc. 983debdf-4a61-4dde-ba34-567fdd17720e 2026-06-11 Warnings Exact identifier application number: M013 Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid ACETAMINOPHEN, DIPHENHYDRAMINE HCL WALGREENS 40b4fe91-b1dd-147c-e063-6294a90a807d 2026-06-09 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PUBLIX SUPERMARKETS, INC 3f17fa06-4932-b8ec-e063-6294a90a0381 2026-06-09 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