Home NDC 57344-080-20 Aspirin
Product NDC 57344-080
Requested package NDC 57344-080-20
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 · 1,570 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 Sample Exclude flag Status 57344-080-20 57344008020 300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-080-20) 2024-03-15 No No Current