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 43 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TIME CAP LABS 59482917-f80b-4bed-9218-068b35366eb3 2025-07-11 Warnings Exact identifier application number: M013 Up and Up Childrens acetaminophen ACETAMINOPHEN Target Corporation 25a476a4-9969-49b3-94bf-b076bada4cea 2025-07-10 Warnings Exact identifier application number: M013 Tylenol Extra Strength Caplet ACETAMINOPHEN Jones Healthcare Group - Packaging Services, Inc fba711c1-4e69-49b0-8994-97c455aebcb2 2025-07-09 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN L. Perrigo Company af7ae548-38ad-41d5-b1cb-761cd2e386d3 2025-07-08 Warnings Exact identifier application number: M013 topcare pain relief ACETAMINOPHEN Topco Associates LLC 6aca88df-d3b5-4a60-b23b-1e66dc41ee7b 2025-07-08 Warnings Exact identifier application number: M013 equate childrens pain and fever ACETAMINOPHEN Wal-Mart Stores Inc f15037a5-4e43-4dd6-93b8-b37a1cc22cd6 2025-07-07 Warnings Exact identifier application number: M013 Childrens Acetaminophen Oral Liquid Grape Flavor ACETAMINOPHEN AARNA USA INC. 39347f5d-2d3c-0c23-e063-6294a90a3a46 2025-07-05 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc be841460-98b4-4448-a494-09ff161fd131 2025-07-02 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN Advanced Rx LLC ad0d6a5c-eee9-406c-8d7f-1df9b45f5340 2025-07-02 Warnings Exact identifier application number: M013 EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE Lil' Drug Store Products, Inc. ec04eb5d-96c0-ddb4-e053-2a95a90a4a92 2025-07-02 Warnings Exact identifier application number: M013 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE Genexa Inc. 18835205-a9e3-15c2-e063-6394a90a8107 2025-07-02 Warnings Exact identifier application number: M013 FeverAll ACETAMINOPHEN Sun Pharmaceutical Industries, Inc. 8970b91b-5f3c-4764-9e23-25dcb398d0a7 2025-07-02 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 11c9712d-c3b2-49cd-9c2b-0f57190c954e 2025-07-02 Warnings Exact identifier application number: M013 Aspirin Regular Strength ASPIRIN United Natural Foods, Inc. dba UNFI 979973c1-661a-4384-8b92-fd901ebde558 2025-07-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN CVS Pharmacy f6bbce1c-9790-4ca4-847f-579c594ffe0b 2025-07-01 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS 07d2e322-2465-79e5-e063-6294a90a5ea4 2025-06-30 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 66c0cf26-357b-4722-9100-3b86d507a8cd 2025-06-30 Warnings Exact identifier application number: M013 ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE Kroger Company bc019c9e-8fac-5fd3-e053-2a95a90a7ccd 2025-06-25 Warnings Exact identifier application number: M013 ACETAMINOPHEN Extra Strength ACETAMINOPHEN TIME CAP LABS INC fd24d0e0-4f36-42d3-9149-2fb957690305 2025-06-25 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN ATLANTIC BIOLOGICALS CORP. 024c5054-959f-4ea5-a71f-c0e16cc4b90c 2025-06-24 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