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

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
Brand name suffix
low dose chewable
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
318272Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5d56618c-8ea2-42ea-a9f2-339bd0055dddAvailable 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
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 TABLET [MAJOR PHARMACEUTICALS]3
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
DEXTRATESINACTIVE INGREDIENTG263MI44RUASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
ORANGEINACTIVE INGREDIENT5EVU04N5QUASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN TABLET [MAJOR PHARMACEUTICALS]3
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
aspirinACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
DEXTRATESINACTIVE INGREDIENTG263MI44RUASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE CHEWABLE (ASPIRIN) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1

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

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 4 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013

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