Home NDC 57344-004 Acetaminophen
Product NDC 57344-004
11-digit product format 573440004
Labeler code 57344
Product ID 57344-004_284cd503-79e7-85a0-e063-6394a90a4783
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-04-13
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57344-004-04 Acetaminophen 1 in 1 CARTON TABLET, COATED 1 5 57344-004-04 Acetaminophen 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5 57344-004-06 Acetaminophen 500 in 1 BOTTLE TABLET, COATED 500 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57344-004 ACETAMINOPHEN TABLET, COATED [AAA PHARMACEUTICAL, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20241204_2d98e390-4f2a-41cc-b307-3d2f6a3700dd.zip
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 58 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN Kroger Company 5bfd9841-c781-43be-b823-d334893ae6ed 2024-10-24 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN H E B add6952e-9dd5-487c-93e6-337e9d6a4872 2024-10-24 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN Safeway, Inc. 7d55cb42-295f-473a-941d-71825b44a3c0 2024-10-24 Warnings Exact identifier application number: M013 rapid release pain relief ACETAMINOPHEN Publix Super Markets Inc d0b34133-d69d-47db-bf51-be942769c612 2024-10-24 Warnings Exact identifier application number: M013 basic care acetaminophen ACETAMINOPHEN Amazon.com Services LLC 00146b91-008d-4b16-95b0-6077f98821be 2024-10-24 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 9a20273e-a4d1-4c38-9efb-e6347f8dc14e 2024-10-24 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e221905b-a795-c067-e053-2a95a90a02e7 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE MARC GLASSMAN, INC. e221bbce-83de-0f03-e053-2995a90abca5 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e231c2f6-927c-1ab0-e053-2995a90a6121 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e23703bb-6087-7985-e053-2995a90aa5ec 2024-10-23 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE MARC GLASSMAN, INC. e237550d-711d-5d87-e053-2995a90affce 2024-10-23 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HARRIS TEETER a6f15f71-1327-4b71-b9d6-e3e9f0243801 2024-10-22 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN HARRIS TEETER 43308b23-7d4f-4e4f-a497-af71920d86aa 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e821c-9694-5db0-e053-2995a90ad034 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN MARC GLASSMAN, INC. e21e90e8-b9f1-1133-e053-2995a90a664b 2024-10-22 Warnings Exact identifier application number: M013 aspirin ASPIRIN Publix Super Markets Inc c51dae48-aa49-4926-b04a-0da264e08dfa 2024-10-22 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN KROGER COMPANY b96a2280-ec4f-7c61-e053-2995a90a18bb 2024-10-22 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN HEB f17a18b0-a7c2-4c64-868c-460cf34e1f7d 2024-10-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN HEB 0863aeaa-15ec-4c67-ba79-4dad54555bd2 2024-10-21 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN American Health Packaging 3c0175a0-175b-48b8-9192-3f869690c0f2 2024-10-21 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 Marketing end Sample Exclude flag Status 57344-004-04 57344000404 1 BOTTLE, PLASTIC in 1 CARTON (57344-004-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-04-13 0000-00-00 No No Current 57344-004-06 57344000406 500 TABLET, COATED in 1 BOTTLE (57344-004-06) 2024-03-15 No No Current