FDA.reportPublic FDA data

aspirin

Product NDC
71679-301
11-digit product format
716790301
Labeler code
71679
Product ID
71679-301_45225ce4-7365-0ee3-e063-6294a90ada30
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Health Pharma USA, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-07
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71679-301-002025-12-05C16284748780-13b156c62-2a62-fb37-e063-e6dba90a4e073165b0a3-556b-6abe-e063-6394a90a7682
71679-301-052025-12-05C16284748780-13b156c62-2a62-fb37-e063-e6dba90a4e073165b0a3-556b-6abe-e063-6394a90a7682
71679-301-102025-12-05C16284748780-13b156c62-2a62-fb37-e063-e6dba90a4e073165b0a3-556b-6abe-e063-6394a90a7682

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71679-301-00aspirin135000 in 1 BOTTLETABLET, DELAYED RELEASE1350005
71679-301-05aspirin500 in 1 BOTTLETABLET, DELAYED RELEASE5005
71679-301-10aspirin1000 in 1 BOTTLETABLET, DELAYED RELEASE10005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN3165b0a3-556b-6abe-e063-6394a90a76825
308416aspirin 81 MG Delayed Release Oral TabletSCD3165b0a3-556b-6abe-e063-6394a90a76825
308416ASA 81 MG Delayed Release Oral TabletSY3165b0a3-556b-6abe-e063-6394a90a76825
308416aspirin 81 MG Enteric Coated Oral TabletSY3165b0a3-556b-6abe-e063-6394a90a76825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71679-301-0071679030100135000 TABLET, DELAYED RELEASE in 1 BOTTLE (71679-301-00) 2024-03-07NoNoHistorical
71679-301-0571679030105500 TABLET, DELAYED RELEASE in 1 BOTTLE (71679-301-05) 2025-04-01NoNoHistorical
71679-301-10716790301101000 TABLET, DELAYED RELEASE in 1 BOTTLE (71679-301-10) 2025-04-01NoNoHistorical