FDA.reportPublic FDA data

LOW DOSE ASPIRIN

Product NDC
63629-8878
11-digit product format
636298878
Labeler code
63629
Product ID
63629-8878_50528ef0-971e-4927-be1d-a1b426789b4c
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-19
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
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
63629-8878-1LOW DOSE ASPIRIN30 in 1 BOTTLE, PLASTICTABLET, COATED30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8878-1EA - Each63629-8878f5fbb3a4-c8a8-42a6-9f9e-42a427d2922e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8878LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240119_d913d11f-c7a1-49d2-a2d3-9a29fc032806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNd913d11f-c7a1-49d2-a2d3-9a29fc032806102
308416aspirin 81 MG Delayed Release Oral TabletSCDd913d11f-c7a1-49d2-a2d3-9a29fc032806102
308416ASA 81 MG Delayed Release Oral TabletSYd913d11f-c7a1-49d2-a2d3-9a29fc032806102
308416aspirin 81 MG Enteric Coated Oral TabletSYd913d11f-c7a1-49d2-a2d3-9a29fc032806102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8878-16362988780130 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-8878-1) 2021-10-010000-00-00NoNoCurrent