Home NDC 57344-080 Aspirin
Product NDC 57344-080
11-digit product format 573440080
Labeler code 57344
Product ID 57344-080_1ac8cf0e-4f03-ff3f-e063-6394a90a5c61
Type HUMAN OTC DRUG
Nonproprietary name ASPIRIN
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-01
Substance ASPIRIN
Active strength 81 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
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 Aspirin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 81 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308416 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 57344-080-01 Aspirin 120 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 120 4 57344-080-01 Aspirin 1 in 1 CARTON TABLET, DELAYED RELEASE 1 4 57344-080-20 Aspirin 300 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 300 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 ASPIRIN ACTIVE MOIETY R16CO5Y76E ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 BROWN IRON OXIDE INACTIVE INGREDIENT 1N032N7MFO ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 DIACETYLATED MONOGLYCERIDES INACTIVE INGREDIENT 5Z17386USF ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57344-080 ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20240615_609948d6-0f20-4d0c-adc0-6ae72a4f2b7a.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 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GOOD REMEDIES Extra Strength Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d642d8e-c154-a970-e063-6294a90a03bf 2025-03-14 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DISCOUNT DRUG MART 97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4 2025-03-07 Warnings Exact identifier application number: M013 Redicare Non-Aspirin 500mg REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG Redicare LLC 2f229898-1777-732c-e063-6394a90a76bc 2025-03-04 Warnings, Adverse reactions Exact identifier application number: M013 Major Extra Strength Acetaminophen Liquid ACETAMINOPHEN Major Pharmaceuticals 2f3af4dd-45d5-87b4-e063-6294a90ab3cc 2025-02-28 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs ed9a71d6-a56e-416a-bb89-6d41307efc5a 2025-02-27 Warnings Exact identifier application number: M013 Aspirin ASPIRIN PD-Rx Pharmaceuticals, Inc. 77429b7f-78e4-42c0-8679-ae8da1748848 2025-02-26 Warnings Exact identifier application number: M013 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
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 57344-080-01 57344008001 1 BOTTLE, PLASTIC in 1 CARTON (57344-080-01) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2017-07-01 0000-00-00 No No Current 57344-080-20 57344008020 300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-080-20) 2024-03-15 No No Current