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 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
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5aaf8b66-b00e-4bc8-972c-bbe6825284fbAvailable on FDA.report

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 INGREDIENTR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
aspirinACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
aspirinACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN 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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
IRONINACTIVE INGREDIENTE1UOL152H7ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [TIME-CAP LABS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET, COATED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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 [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc5aaf8b66-b00e-4bc8-972c-bbe6825284fb2018-12-17WarningsExact identifier
ndc (product): 49483-387

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