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 38 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC ab02080a-c903-4e4a-a9f3-2b8197ed2f2b 2025-09-17 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 79669930-f744-4bb1-8325-b75951489b64 2025-09-17 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. ff199db8-c7ea-4b6e-ad8b-3ceeca883d92 2025-09-15 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL FOODHOLD U.S.A., LLC fdd7ce80-d6be-41b9-affd-d024cf306b50 2025-09-12 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 3e89240b-0e27-fde4-e063-6394a90a779f 2025-09-11 Warnings Exact identifier application number: M013 Aspirin 81 mg Low Dose ASPIRIN HEB 926fe7b6-9607-469f-912f-4019891067a9 2025-09-10 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Unifirst First Aid Corporation 356e4ff4-a7f1-4a50-9b86-2555e232b300 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Aspirin ASPIRIN Unifirst First Aid Corporation b5a469c1-9ab4-5bd7-e053-2995a90a86d1 2025-09-09 Warnings Exact identifier application number: M013 Medique Products Aspirin ASPIRIN Unifirst First Aid Corporation 9b28fed0-a993-ca72-e053-2995a90ac7fd 2025-09-09 Warnings Exact identifier application number: M013 Unishield Aspirin ASPIRIN Unishield ba106b20-32ac-df90-e053-2995a90adaef 2025-09-09 Warnings Exact identifier application number: M013 Medi First Pain Ache ASPIRIN,CAFFEINE Unifirst First Aid Corporation e82d02d5-3e44-a8f8-e053-2a95a90a2688 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Back Pain Relief MAGNESIUM SALICYLATE Unifirst First Aid Corporation e56c4aef-fa0b-74db-e053-2a95a90a9745 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Aspirin ASPIRIN Bellegrove Medical Supply, Inc. bae80044-ad7f-3bf5-e053-2995a90a42f9 2025-09-09 Warnings Exact identifier application number: M013 McKesson Aspirin ASPIRIN McKesson Medical-Surgical dabd741e-e11c-52c1-e053-2a95a90a91d5 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Non-Aspirin ACETAMINOPHEN 325MG Bellegrove Medical Supply, Inc. 6ab08633-5d5a-42b2-e053-2991aa0ab41a 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC 1c7369ea-46b6-407c-aa4b-048eb72ff03f 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Extra Strength Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC a524c36a-38f3-4266-8f45-589e19400328 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin ASPIRIN Direct Safety ba9ba697-d3df-49d7-e053-2a95a90af406 2025-09-09 Warnings Exact identifier application number: M013 McKesson Acetaminophen 325 ACETAMINOPHEN McKesson Medical-Surgical, Inc. bc2daba5-ce8b-bbda-e053-2a95a90a6f33 2025-09-09 Warnings Exact identifier application number: M013 Uline Acetaminophen Extra Strength ACETAMINOPHEN Uline 90167594-0a49-2492-e053-2a95a90a1401 2025-09-09 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