Home NDC 57237-346 Acetaminophen
Product NDC 57237-346
11-digit product format 572370346
Labeler code 57237
Product ID 57237-346_d19afb8f-7095-47fb-ae86-6efa69764655
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-09
Substance ACETAMINOPHEN
Active strength 325 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 Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-346-01 Acetaminophen 100 in 1 BOTTLE TABLET, FILM COATED 100 4 57237-346-10 Acetaminophen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 57237-346-01 57237034601 100 TABLET, FILM COATED in 1 BOTTLE (57237-346-01) 2025-07-09 No No Current 57237-346-10 57237034610 1000 TABLET, FILM COATED in 1 BOTTLE (57237-346-10) 2025-07-09 No No Current