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 67 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cafiaspirina Rapid Headache Relief ASPIRIN, CAFFEINE Belmora LLC d890acec-6528-4fb7-8d59-6c572a3f0786 2024-06-07 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE TARGET Corporation 611bc1ce-460a-44a3-8e2d-b28a399d9a44 2024-06-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Meijer Distribution Inc 033a6153-2651-4703-8a94-def461838113 2024-06-05 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 126ee71a-c408-415b-9a43-502337a91055 2024-06-05 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN A-S Medication Solutions 85294a70-3233-4ba5-bc36-ee3f2964aebf 2024-06-05 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN 81MG Lodaat LLC 6a35f38c-a240-4f8c-9a8e-8d283b67b55b 2024-06-04 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN 81MG Lodaat LLC 1ec12f4b-de05-4990-a7b7-f82d867361de 2024-06-04 Warnings Exact identifier application number: M013 CareOne Infants Acetaminophen ACETAMINOPHEN American Sales Company 0a28a4f1-d947-489b-be28-36ba10b581cf 2024-06-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack 77fb237f-28b5-486b-b9ef-cb324d5cc0bd 2024-05-30 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack b5053cf5-209d-4106-afc2-cf9af85f4a69 2024-05-29 Warnings Exact identifier application number: M013 topcare infants pain and fever ACETAMINOPHEN Topco Associates LLC f129bc0e-1ef1-42a8-8668-2ee88ffc85e3 2024-05-23 Warnings Exact identifier application number: M013 Good Neighbor Pharmacy Childrens Pain and Fever ACETAMINOPHEN Amerisource Bergen 074fdf65-f6ce-46d4-87cc-46911c01cca5 2024-05-23 Warnings Exact identifier application number: M013 DG Health Childrens Pain and Fever ACETAMINOPHEN Dolgencorp, LLC 779cf607-245f-408a-81e8-8000c0ea4c4a 2024-05-22 Warnings Exact identifier application number: M013 good sense pain and fever infants ACETAMINOPHEN L. Perrigo Company 7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb4 2024-05-21 Warnings Exact identifier application number: M013 Extra Strength Night Time Pain Medicine ACETAMINOPHEN, DIPHENHYDRAMINE HCL Geri-Care Pharmaceutical Corp 2b8f83ed-1ca9-49ac-9b2a-2609b68200f9 2024-05-21 Warnings Exact identifier application number: M013 Acetaminophen Solution ACETAMINOPHEN Patrin Pharma, Inc. 52ae729b-2255-420c-8db8-cabdc2b74796 2024-05-21 Warnings Exact identifier application number: M013 Ibuprofen, Lil Drug Store IBUPROFEN Lil' Drug Store products, Inc. 18e80dab-6837-fd2d-e063-6294a90a73c8 2024-05-20 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN QUALITY CHOICE (Chain Drug Marketing Association) 2f9da3d6-229d-44d1-bd94-4bcddbbdb120 2024-05-20 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 07d34e7a-c0c6-f3c4-e063-6294a90aa5c3 2024-05-18 Warnings Exact identifier application number: M013 AMAZON BASIC CARE ACETAMINOPHEN ACETAMINOPHEN Amazon.com Services LLC 10ee2f40-858d-bed4-e063-6394a90a86bb 2024-05-17 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 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