FDA.reportPublic FDA data

Aspirin

Product NDC
49483-349
11-digit product format
494830349
Labeler code
49483
Product ID
49483-349_7cff0ad4-677a-03f7-e053-2a91aa0af7ae
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-12-23
Substance
ASPIRIN
Active strength
81 mg/811
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
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/811

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

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
49483-349-00AspirinDelayed Release100000 in 1 CARTONTABLET, DELAYED RELEASE1000003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-349ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]3Current NDC, Legacy NDC, 1 package rows20181215_70d8ba6c-8dfe-402a-817d-22544141d160.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN70d8ba6c-8dfe-402a-817d-22544141d1603
308416aspirin 81 MG Delayed Release Oral TabletSCD70d8ba6c-8dfe-402a-817d-22544141d1603
308416ASA 81 MG Delayed Release Oral TabletSY70d8ba6c-8dfe-402a-817d-22544141d1603
308416aspirin 81 MG Enteric Coated Oral TabletSY70d8ba6c-8dfe-402a-817d-22544141d1603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-349-0049483034900100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-349-00) 2018-12-140000-00-00NoNoCurrent