FDA.reportPublic FDA data

aspirin

Product NDC
0904-4040
11-digit product format
009044040
Labeler code
0904
Product ID
0904-4040_6df8fec2-6cf9-4c90-98b5-3d53901f21d6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-12
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-4040-73aspirin1 in 1 CARTONTABLET, CHEWABLE16
0904-4040-73aspirin36 in 1 BOTTLETABLET, CHEWABLE366

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-4040-73EA - Each0904-4040bb5cc8ec-5b24-4182-ad88-2e3f6251767912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]3
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-4040ASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20240915_58684138-04d1-44a4-bc52-c5b85d93d7a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN65c41c20-2f9c-4012-900b-c2ffdf66514410
318272aspirin 81 MG Chewable TabletSCD65c41c20-2f9c-4012-900b-c2ffdf66514410
318272ASA 81 MG Chewable TabletSY65c41c20-2f9c-4012-900b-c2ffdf66514410
318272aspirin 81 MG Chewable TabletPSN58684138-04d1-44a4-bc52-c5b85d93d7a66
318272aspirin 81 MG Chewable TabletSCD58684138-04d1-44a4-bc52-c5b85d93d7a66
318272ASA 81 MG Chewable TabletSY58684138-04d1-44a4-bc52-c5b85d93d7a66
318272aspirin 81 MG Chewable TabletPSN3c7783a7-2b28-4968-b766-0a49dc70ce6d5
318272aspirin 81 MG Chewable TabletSCD3c7783a7-2b28-4968-b766-0a49dc70ce6d5
318272ASA 81 MG Chewable TabletSY3c7783a7-2b28-4968-b766-0a49dc70ce6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-4040-73009044040731 BOTTLE in 1 CARTON (0904-4040-73) / 36 TABLET, CHEWABLE in 1 BOTTLE1 bottle2007-12-120000-00-00NoNoCurrent