Home NDC 57344-170 Pain Relief
Product NDC 57344-170
11-digit product format 573440170
Labeler code 57344
Product ID 57344-170_284f8938-9753-c321-e063-6294a90a4895
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 2015-01-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Pain Relief
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57344-170-01 Pain Relief 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 7 57344-170-01 Pain Relief 1 in 1 CARTON TABLET, COATED 1 7 57344-170-02 Pain Relief 1 in 1 CARTON TABLET, COATED 1 7 57344-170-02 Pain Relief 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 7 57344-170-03 Pain Relief 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 7 57344-170-03 Pain Relief 1 in 1 CARTON TABLET, COATED 1 7 57344-170-12 Pain Relief 400 in 1 BOTTLE, PLASTIC TABLET, COATED 400 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN RAPID RELEASE (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN RAPID RELEASE (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 57344-170 PAIN RELIEF (ACETAMINOPHEN) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 7 Current NDC, Legacy NDC, 7 package rows 20241204_a891896d-c9fa-4448-915a-e6b531157d22.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 47 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AeroTab Non-Aspirin ACETAMINOPHEN 500MG ES Aero Healthcare faa3a4ef-3c70-06ca-e053-6394a90a512d 2025-02-26 Warnings Exact identifier application number: M013 Bufferin Regular Strength Pain Relief ASPIRIN Genomma Lab USA 3543b2bf-1062-468a-a5dc-eabb2408af8c 2025-02-25 Warnings Exact identifier application number: M013 Calmour Childrens Acetaminophen Strips Chewable ACETAMINOPHEN ORAL CHEWABLE 80 MG Calmour ae47b027-4f29-45bb-a8bd-812978932835 2025-02-22 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC f9de7c2f-016b-4f40-8b5e-141ad194be97 2025-02-20 Warnings Exact identifier application number: M013 Genexa Acetaminophen PM Extra Strength ACETAMINOPHEN Genexa Inc. d82cf6f3-a291-ca2b-e053-2a95a90a6de1 2025-02-20 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Advagen Pharma Limited 8b9456c9-a56b-4748-adb8-c66d6bf072e8 2025-02-19 Warnings Exact identifier application number: M013 Genexa Childrens Acetaminophen ACETAMINOPHEN Genexa Inc. d89fd9d8-d88e-3968-e053-2a95a90afc5f 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. debfa787-7a48-48b5-94b0-612820524032 2025-02-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. b16e5dcf-b290-4ff2-a150-4b875647ec9a 2025-02-19 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC bb6533e5-e6a9-488c-b8ab-a6a06e87ede9 2025-02-18 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC c830320e-72ba-48ff-a4cd-250ac5650bf0 2025-02-18 Warnings Exact identifier application number: M013 Aspirina Caplets ASPIRIN Bayer HealthCare LLC. 2e6f5ba8-8e8b-6059-e063-6394a90adcd5 2025-02-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. da7d95af-6583-429d-8d04-e0424f32e9ad 2025-02-17 Warnings Exact identifier application number: M013 GOODYS Mental Alert ASPIRIN AND CAFFEINE Medtech Products Inc. 31ef6d07-d314-4d09-abcd-389ba66cbcc5 2025-02-17 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Asclemed USA, Inc. 878dab20-668b-4d7a-a5f8-794a587564d5 2025-02-13 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN CVS HEALTH CORP bbc48c9e-7eb8-2c67-e053-2a95a90a8552 2025-02-13 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN CVS 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 2025-02-13 Warnings Exact identifier application number: M013 NOTTS - Extra Strength 500 mg ACETAMINOPHEN VIVUNT PHARMA LLC e677f43d-b4ce-e5b0-e053-2a95a90ad67e 2025-02-12 Warnings Exact identifier application number: M013 Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN, ASPIRIN, CAFFEINE LEADER/ Cardinal Health 110, Inc. b3773f02-02a9-33c8-e053-2995a90a2235 2025-02-11 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC. c9f80d24-bd05-e1ce-e053-2995a90aa646 2025-02-10 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 57344-170-01 57344017001 1 BOTTLE, PLASTIC in 1 CARTON (57344-170-01) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-09-01 0000-00-00 No No Current 57344-170-02 57344017002 1 BOTTLE, PLASTIC in 1 CARTON (57344-170-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2015-01-01 0000-00-00 No No Current 57344-170-03 57344017003 1 BOTTLE, PLASTIC in 1 CARTON (57344-170-03) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2017-09-01 0000-00-00 No No Current 57344-170-12 57344017012 400 TABLET, COATED in 1 BOTTLE, PLASTIC (57344-170-12) 2017-10-01 0000-00-00 No No Current