FDA.reportPublic FDA data

aspirin

Product NDC
49483-334
11-digit product format
494830334
Labeler code
49483
Product ID
49483-334_16498b52-a996-8c49-e063-6294a90a1253
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-07-16
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
low dose 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-334-00aspirinlow dose chewable100000 in 1 CARTONTABLET, CHEWABLE1000004
49483-334-19aspirinlow dose chewable36 in 1 BOTTLETABLET, CHEWABLE364
49483-334-19aspirinlow dose chewable3 in 1 CARTONTABLET, CHEWABLE34
49483-334-63aspirinlow dose chewable36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE364

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-334-63EA - Each49483-33410867ed2-4d3a-4fcb-9e26-5b270e6ceb6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
DEXTRATESINACTIVE INGREDIENTG263MI44RUASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-334ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [TIME-CAP LABS, INC]4Current NDC, Legacy NDC, 4 package rows20240418_5d56618c-8ea2-42ea-a9f2-339bd0055ddd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN5d56618c-8ea2-42ea-a9f2-339bd0055ddd4
318272aspirin 81 MG Chewable TabletSCD5d56618c-8ea2-42ea-a9f2-339bd0055ddd4
318272ASA 81 MG Chewable TabletSY5d56618c-8ea2-42ea-a9f2-339bd0055ddd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-334-0049483033400100000 TABLET, CHEWABLE in 1 CARTON (49483-334-00) 2018-12-170000-00-00NoNoCurrent
49483-334-19494830334193 BOTTLE in 1 CARTON (49483-334-19) / 36 TABLET, CHEWABLE in 1 BOTTLE3 bottle2024-04-19NoNoCurrent
49483-334-634948303346336 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (49483-334-63) 2018-12-170000-00-00NoNoCurrent