FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
49483-328
11-digit product format
494830328
Labeler code
49483
Product ID
49483-328_7d3b6a67-60c8-162a-e053-2991aa0a7164
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
2010-08-11
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
Low Dose Aspirin
Brand name suffix
Enteric Safety 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
55d645bb-8645-4984-a7b9-3e6eed8c6412Available 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
49483-328-01Low Dose AspirinEnteric Safety Coated100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1002
49483-328-10Low Dose AspirinEnteric Safety Coated1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ELOW DOSE ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76ELOW DOSE ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-328LOW DOSE ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]2Current NDC, Legacy NDC, 2 package rows20181219_55d645bb-8645-4984-a7b9-3e6eed8c6412.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
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc55d645bb-8645-4984-a7b9-3e6eed8c64122018-12-17WarningsExact identifier
ndc (product): 49483-328

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN55d645bb-8645-4984-a7b9-3e6eed8c64122
308416aspirin 81 MG Delayed Release Oral TabletSCD55d645bb-8645-4984-a7b9-3e6eed8c64122
308416ASA 81 MG Delayed Release Oral TabletSY55d645bb-8645-4984-a7b9-3e6eed8c64122
308416aspirin 81 MG Enteric Coated Oral TabletSY55d645bb-8645-4984-a7b9-3e6eed8c64122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-328-0149483032801100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-328-01) 2018-12-170000-00-00NoNoCurrent
49483-328-10494830328101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-328-10) 2018-12-170000-00-00NoNoCurrent