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 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
49483-328-01Low 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

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