FDA.reportPublic FDA data

Aspirin

Product NDC
41163-522
11-digit product format
411630522
Labeler code
41163
Product ID
41163-522_38de9170-ee81-4f0a-e063-6294a90a5f63
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-01
Substance
ASPIRIN
Active strength
325 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41163-52241163-522-05DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979973c1-661a-4384-8b92-fd901ebde558Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-522-02AspirinRegular Strength1 in 1 CARTONTABLET, DELAYED RELEASE15
41163-522-02AspirinRegular Strength125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1255
41163-522-05AspirinRegular Strength1 in 1 CARTONTABLET, DELAYED RELEASE15
41163-522-05AspirinRegular Strength500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE5005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-522ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 4 package rows20241019_979973c1-661a-4384-8b92-fd901ebde558.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN979973c1-661a-4384-8b92-fd901ebde5585
198467aspirin 325 MG Delayed Release Oral TabletSCD979973c1-661a-4384-8b92-fd901ebde5585
198467ASA 325 MG Delayed Release Oral TabletSY979973c1-661a-4384-8b92-fd901ebde5585
198467aspirin 325 MG Enteric Coated Oral TabletSY979973c1-661a-4384-8b92-fd901ebde5585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-522-02411630522021 BOTTLE, PLASTIC in 1 CARTON (41163-522-02) / 125 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2014-11-010000-00-00NoNoCurrent
41163-522-05411630522051 in 1 CARTONHistorical