FDA.reportPublic FDA data

Aspirin 81mg Enteric Coated

Product NDC
77333-031
11-digit product format
773330031
Labeler code
77333
Product ID
77333-031_5d297e80-59c6-fb69-e063-6394a90ab9e0
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
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
2027-12-31
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 81mg Enteric Coated
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

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
77333-031-20Aspirin 81mg Enteric Coated150 in 1 CARTONTABLET, DELAYED RELEASE1501
77333-031-25Aspirin 81mg Enteric Coated1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-031-20EA - Each77333-03185eb169d-e2f9-45af-8243-e5450ed3cde812025-05-14
77333-031-25EA - Each77333-031f4575ebe-fdd0-4355-b91e-7fd0193f093a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-031ASPIRIN 81MG ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [GENDOSE PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250501_7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7.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 34 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWalmart Inc.1557bd9b-3e7c-4769-e063-6394a90a9d912025-11-04WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINRising Pharma Holdings, Inc.c3c4854e-726e-4926-b044-a5094943c3062025-11-04WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e50b3f6-1e1a-41b9-e063-6394a90abe362025-11-03WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company447de441-7d28-4415-81c5-4fc05622dd052025-11-03WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENVERITYRX. LLC42a17f54-7851-84fb-e063-6394a90a9ec12025-11-02WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENVERITYRX, LLC42a1a128-a2dd-bbc9-e063-6294a90a4fe12025-11-02WarningsExact identifier
application number: M013
Physicians Care AspirinASPIRINAcme United Corporationaa67ea3a-2741-7ee0-e053-2a95a90a64852025-10-31WarningsExact identifier
application number: M013
PhysiciansCare Non Aspirin Extra StrengthACETAMINOPHENAcme United Corporationc7006775-bd5b-412f-963d-ce5a158216c52025-10-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreensf7aa624b-b00c-4fd3-9965-8e4d2b3eb4ba2025-10-31WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENNuCare Pharmaceuticals, Inc.41affa1a-5aac-7fc0-e063-6394a90a55572025-10-30WarningsExact identifier
application number: M013
MAPAP Extra StrengthACETAMINOPHENMajor Pharmaceuticals34a95450-3f04-4de4-9113-73e7bd5724a02025-10-29WarningsExact identifier
application number: M013
GOODNOW PAIN RELIEFACETAMINOPHENGobrands, Inc4d4a78a5-5a88-4f24-b685-c7c6bb5e989e2025-10-29WarningsExact identifier
application number: M013
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.f8237772-7656-49fb-b1de-f8fcb5fa55ee2025-10-28WarningsExact identifier
application number: M013
DG Health Pain ReliefACETAMINOPHENDolgencorp Inc42f0c87c-7020-4af7-9f6b-3a774137e5642025-10-24WarningsExact identifier
application number: M013
GOODYS HangoverASPIRIN AND CAFFEINEMedtech Products Inc.0b0067e0-58b0-4581-aa4b-e398c32c559a2025-10-23WarningsExact identifier
application number: M013
GOODYS Extra Strength Headache Mixed Fruit BlastACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.6cb758bf-5a50-46bb-96e7-65b810b12de02025-10-23WarningsExact identifier
application number: M013
Nyt Time Sleep CapsDIPHENHYDRAMINE HYDROCHLORIDEDISCOUNT DRUG MARTe3f4d063-921d-4503-89a6-26cc9c46b4c92025-10-23WarningsExact identifier
application number: M013
AnacinASPRIN AND CAFFEINEInsight Pharmaceuticals LLC51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff2025-10-23WarningsExact identifier
application number: M013
Goodys Back and Body PainACETAMINOPHEN AND ASPRINMedtech Products Inc.055d0288-61d4-48bc-b91f-6ecc1969beb82025-10-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416aspirin 81 MG Delayed Release Oral TabletSCD7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416ASA 81 MG Delayed Release Oral TabletSY7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71
308416aspirin 81 MG Enteric Coated Oral TabletSY7342bbf4-ebb9-446d-83bb-6ddcb3a44fa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77333-031-2077333003120150 BLISTER PACK in 1 CARTON (77333-031-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-031-25) 150 blister pack2025-05-01NoNoCurrent
77333-031-25773330031251 in 1 BLISTER PACKHistorical