FDA.reportPublic FDA data

Aspirin

Product NDC
59779-600
Requested package NDC
59779-600-06
11-digit product format
597790600
Labeler code
59779
Product ID
59779-600_efb8edcf-a8cc-4d53-bf00-3a5ab8ae67b6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-05-01
Marketing end
2028-05-31
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
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
Brand name suffix
Enteric Coated

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 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
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c55304be-bfc0-46a8-a37e-2e6ba9098394Available 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
59779-600-06AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-06AspirinEnteric Coated200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE20019
59779-600-07AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-07AspirinEnteric Coated36 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3619
59779-600-14AspirinEnteric Coated500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50019
59779-600-16AspirinEnteric Coated1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100019
59779-600-17AspirinEnteric Coated300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30019
59779-600-27AspirinEnteric Coated32 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3219
59779-600-27AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-29AspirinEnteric Coated150 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE15019
59779-600-29AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-32AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-32AspirinEnteric Coated120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12019
59779-600-90AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
59779-600-90AspirinEnteric Coated230 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE23019
59779-600-91AspirinEnteric Coated360 in 1 BOTTLETABLET, DELAYED RELEASE36019
59779-600-99AspirinEnteric Coated2 in 1 CARTONTABLET, DELAYED RELEASE219
59779-600-99AspirinEnteric Coated120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-600-06EA - Each59779-6004f4317c9-c741-4ffa-84dd-7e1f6641163912017-06-15
59779-600-14EA - Each59779-600f775ae33-04ba-4ce0-8756-cabf3d6de15212017-06-15
59779-600-16EA - Each59779-600b082b5b0-05dc-4b33-b3ab-d153ed695b8012017-06-15
59779-600-17EA - Each59779-600229c4241-3e1a-4035-bb13-df273c12869a12017-06-15
59779-600-27EA - Each59779-6004f77eb7b-b1a4-4a3b-bce2-29bd40b181c412017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED (ASPIRIN) TABLET, COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-600ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CVS PHARMACY]17Current NDC, Legacy NDC, 18 package rows20241116_c55304be-bfc0-46a8-a37e-2e6ba9098394.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
308416aspirin 81 MG Delayed Release Oral TabletPSNc55304be-bfc0-46a8-a37e-2e6ba909839419
308416aspirin 81 MG Delayed Release Oral TabletSCDc55304be-bfc0-46a8-a37e-2e6ba909839419
308416ASA 81 MG Delayed Release Oral TabletSYc55304be-bfc0-46a8-a37e-2e6ba909839419
308416aspirin 81 MG Enteric Coated Oral TabletSYc55304be-bfc0-46a8-a37e-2e6ba909839419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-600-06597790600061 BOTTLE, PLASTIC in 1 CARTON (59779-600-06) / 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-012027-12-31NoNoCurrent