FDA.reportPublic FDA data

aspirin

Product NDC
49483-387
11-digit product format
494830387
Labeler code
49483
Product ID
49483-387_7d3f2035-b032-633c-e053-2991aa0a59f2
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-06-28
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 enteric coated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
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
49483-387-00aspirinlow dose enteric coated100000 in 1 CARTONTABLET, COATED1000003
49483-387-10aspirinlow dose enteric coated1000 in 1 BOTTLE, PLASTICTABLET, COATED10003
49483-387-12aspirinlow dose enteric coated120 in 1 BOTTLE, PLASTICTABLET, COATED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-387-00EA - Each49483-3873f67641d-ded2-4398-a7c8-755c11baeb6a12022-06-06
49483-387-12EA - Each49483-387d030cc62-0ae3-4f8e-b43a-cd027d175db012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
aspirinACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
aspirinACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
IRONINACTIVE INGREDIENTE1UOL152H7ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-387ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]3Current NDC, Legacy NDC, 3 package rows20181218_5aaf8b66-b00e-4bc8-972c-bbe6825284fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNf4743dca-8d91-4811-b229-5b6cb38cc8846
308416aspirin 81 MG Delayed Release Oral TabletSCDf4743dca-8d91-4811-b229-5b6cb38cc8846
308416ASA 81 MG Delayed Release Oral TabletSYf4743dca-8d91-4811-b229-5b6cb38cc8846
308416aspirin 81 MG Enteric Coated Oral TabletSYf4743dca-8d91-4811-b229-5b6cb38cc8846
308416aspirin 81 MG Delayed Release Oral TabletPSN5aaf8b66-b00e-4bc8-972c-bbe6825284fb3
308416aspirin 81 MG Delayed Release Oral TabletSCD5aaf8b66-b00e-4bc8-972c-bbe6825284fb3
308416ASA 81 MG Delayed Release Oral TabletSY5aaf8b66-b00e-4bc8-972c-bbe6825284fb3
308416aspirin 81 MG Enteric Coated Oral TabletSY5aaf8b66-b00e-4bc8-972c-bbe6825284fb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-387-0049483038700100000 TABLET, COATED in 1 CARTON (49483-387-00) 2018-12-170000-00-00NoNoCurrent
49483-387-10494830387101000 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-387-10) 2018-12-170000-00-00NoNoCurrent
49483-387-1249483038712120 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-387-12) 2018-12-170000-00-00NoNoCurrent