FDA.reportPublic FDA data

Aspirin 81 mg

Product NDC
37808-246
11-digit product format
378080246
Labeler code
37808
Product ID
37808-246_3e75f45a-7cf3-c30b-e063-6394a90a7512
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HEB
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-01
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 81 mg
Brand name suffix
Low Dose
Listing expiration
2026-12-31

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
926fe7b6-9607-469f-912f-4019891067a9Available 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
37808-246-01Aspirin 81 mgLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE15
37808-246-01Aspirin 81 mgLow Dose180 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1805
37808-246-02Aspirin 81 mgLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE15
37808-246-02Aspirin 81 mgLow Dose300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-246ASPIRIN 81 MG LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [HEB]4Current NDC, Legacy NDC, 4 package rows20241023_926fe7b6-9607-469f-912f-4019891067a9.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 56 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association70d265de-ff94-e0e4-e053-2a91aa0a962a2024-11-13WarningsExact identifier
application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association9f7d0c96-a561-a8a0-e053-2995a90a250b2024-11-13WarningsExact identifier
application number: M013
WinCo Foods Effervescent Antacid and Pain ReliefASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLETWinCo Foods, LLC0c8a755a-089f-477f-97e9-0dd6fdfbe99d2024-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company8fb19444-f0e0-4d26-81e8-6a4b835056d82024-11-12WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.59d01f72-4575-48e2-b914-b6a6456ca7d22024-11-11WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENKroger Companyd181560c-1c39-4f2e-8a17-996224ca040f2024-11-09WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINAcme United Corporationf7f9dc46-a945-7ae3-e053-6394a90a11922024-11-08WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLCde5c6654-56c5-40d3-a286-f04ed47ac7c82024-11-07WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEAcme United Corporationf7bf126d-a6f1-231a-e053-6294a90a04e12024-11-07WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company49021ae8-9655-4885-9f74-52df4cdcb26f2024-11-07WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN926fe7b6-9607-469f-912f-4019891067a95
308416aspirin 81 MG Delayed Release Oral TabletSCD926fe7b6-9607-469f-912f-4019891067a95
308416ASA 81 MG Delayed Release Oral TabletSY926fe7b6-9607-469f-912f-4019891067a95
308416aspirin 81 MG Enteric Coated Oral TabletSY926fe7b6-9607-469f-912f-4019891067a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-246-01378080246011 BOTTLE, PLASTIC in 1 CARTON (37808-246-01) / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-01-010000-00-00NoNoCurrent
37808-246-02378080246021 BOTTLE, PLASTIC in 1 CARTON (37808-246-02) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2010-04-010000-00-00NoNoCurrent