FDA.reportPublic FDA data

Enteric Coated Aspirin

Product NDC
71335-0157
11-digit product format
713350157
Labeler code
71335
Product ID
71335-0157_ea93b3a0-8e27-4117-9bb9-f4d239f4326b
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-04
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

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
Enteric Coated 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
e05140fa-9766-4f97-bffc-e36a01b9d38fAvailable 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
71335-0157-1Enteric Coated AspirinRegular Strength30 in 1 BOTTLETABLET, DELAYED RELEASE307
71335-0157-2Enteric Coated AspirinRegular Strength60 in 1 BOTTLETABLET, DELAYED RELEASE607
71335-0157-3Enteric Coated AspirinRegular Strength100 in 1 BOTTLETABLET, DELAYED RELEASE1007
71335-0157-4Enteric Coated AspirinRegular Strength90 in 1 BOTTLETABLET, DELAYED RELEASE907
71335-0157-5Enteric Coated AspirinRegular Strength20 in 1 BOTTLETABLET, DELAYED RELEASE207
71335-0157-6Enteric Coated AspirinRegular Strength45 in 1 BOTTLETABLET, DELAYED RELEASE457
71335-0157-7Enteric Coated AspirinRegular Strength120 in 1 BOTTLETABLET, DELAYED RELEASE1207
71335-0157-8Enteric Coated AspirinRegular Strength7 in 1 BOTTLETABLET, DELAYED RELEASE77

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0157-1EA - Each71335-0157f7af8ac8-69d1-4242-bf2b-1df8c63e255f12018-03-08
71335-0157-2EA - Each71335-0157ed6c0a3e-d1fa-45bf-bf4f-af3597b9ceac12018-03-08
71335-0157-3EA - Each71335-0157e922b657-520b-4f3a-97e6-8d3728b21e9b12018-03-08
71335-0157-4EA - Each71335-01577aea305c-de88-455d-a888-bd6d27e941e012018-03-08
71335-0157-5EA - Each71335-01571fa4e357-329f-4999-a38b-c2458cef5b7d12018-03-08
71335-0157-6EA - Each71335-015740fbc60e-9b98-4f8b-a410-fccea818cf2b12018-03-08
71335-0157-7EA - Each71335-015774000532-c213-4077-8a26-0ad277668fa512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0157ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 8 package rows20240126_e05140fa-9766-4f97-bffc-e36a01b9d38f.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 · 1,576 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 TabletPSNe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467aspirin 325 MG Delayed Release Oral TabletSCDe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467ASA 325 MG Delayed Release Oral TabletSYe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467aspirin 325 MG Enteric Coated Oral TabletSYe05140fa-9766-4f97-bffc-e36a01b9d38f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0157-17133501570130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-1) 2022-02-090000-00-00NoNoCurrent
71335-0157-27133501570260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-2) 2022-02-090000-00-00NoNoCurrent
71335-0157-371335015703100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-3) 2018-04-190000-00-00NoNoCurrent
71335-0157-47133501570490 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-4) 2022-02-090000-00-00NoNoCurrent
71335-0157-57133501570520 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-5) 2022-02-090000-00-00NoNoCurrent
71335-0157-67133501570645 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-6) 2022-02-090000-00-00NoNoCurrent
71335-0157-771335015707120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-7) 2022-02-090000-00-00NoNoCurrent
71335-0157-8713350157087 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0157-8) 2022-02-090000-00-00NoNoCurrent