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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 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