FDA.reportPublic FDA data

Aspirin

Product NDC
69168-288
11-digit product format
691680288
Labeler code
69168
Product ID
69168-288_4c94e807-e4ed-45b7-84ed-9611542472f7
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-18
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

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Chewable
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui318272

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-288-012020-03-13C16284748780-19d75b9d0-989e-f424-e053-dadaa90a57ceDrug Facts
69168-288-362020-03-13C16284748780-19d75b9d0-989e-f424-e053-dadaa90a57ceDrug Facts
69168-288-012020-01-31C16284748780-19d75b9d0-989e-f424-e053-dadaa90a57ceDrug Facts
69168-288-362020-01-31C16284748780-19d75b9d0-989e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-288-01AspirinChewable100 in 1 BOTTLETABLET1007
69168-288-36AspirinChewable1 in 1 CARTONTABLET17
69168-288-36AspirinChewable36 in 1 BOTTLETABLET367

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
DEXTRATESINACTIVE INGREDIENTG263MI44RUASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-288ASPIRIN CHEWABLE (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]7Current NDC, Legacy NDC, 3 package rows20231020_92b8637b-03a9-461f-b2f6-6eddaa214953.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN92b8637b-03a9-461f-b2f6-6eddaa2149537
318272aspirin 81 MG Chewable TabletSCD92b8637b-03a9-461f-b2f6-6eddaa2149537
318272ASA 81 MG Chewable TabletSY92b8637b-03a9-461f-b2f6-6eddaa2149537
318272aspirin 81 MG Chewable TabletPSNb499f378-db7c-464e-bee3-eb23f8fdaced2
318272aspirin 81 MG Chewable TabletSCDb499f378-db7c-464e-bee3-eb23f8fdaced2
318272ASA 81 MG Chewable TabletSYb499f378-db7c-464e-bee3-eb23f8fdaced2
318272aspirin 81 MG Chewable TabletPSN305170b7-8cd8-405d-b556-445a4268d6171
318272aspirin 81 MG Chewable TabletSCD305170b7-8cd8-405d-b556-445a4268d6171
318272ASA 81 MG Chewable TabletSY305170b7-8cd8-405d-b556-445a4268d6171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-288-0169168028801100 TABLET in 1 BOTTLE (69168-288-01) 100 tablet2014-12-180000-00-00NoNoCurrent
69168-288-36691680288361 BOTTLE in 1 CARTON (69168-288-36) / 36 TABLET in 1 BOTTLE1 bottle2014-12-180000-00-00NoNoCurrent