FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
71399-8627
11-digit product format
713998627
Labeler code
71399
Product ID
71399-8627_7c67ef4d-3d10-44bb-9cc4-f270c92ef537
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Akron Phama
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-12
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-8627-12025-03-10C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-22025-03-10C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-12025-01-30C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-22025-01-30C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-12023-02-10C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-22023-02-10C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-12023-01-30C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose
71399-8627-22023-01-30C16284748780-1f386c649-ff69-0266-e053-dadaa90a7c1aAspirin Low Dose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8627-1Low Dose Aspirin1000 in 1 BOTTLETABLET, COATED10004
71399-8627-2Low Dose Aspirin120 in 1 BOTTLETABLET, COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8627-1EA - Each71399-8627f3306955-787e-4644-b4a5-8b9fa03792e012021-07-15
71399-8627-2EA - Each71399-862711779293-9607-4ff1-b4d8-7f27c6bf3d8e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8627LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [AKRON PHAMA]3Current NDC, Legacy NDC, 2 package rows20250312_cfe9dc65-dfbb-4c36-a8c9-57bb460a8d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416aspirin 81 MG Delayed Release Oral TabletSCDcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416ASA 81 MG Delayed Release Oral TabletSYcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416aspirin 81 MG Enteric Coated Oral TabletSYcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71399-8627-1713998627011000 TABLET, COATED in 1 BOTTLE (71399-8627-1) 2021-05-120000-00-00NoNoCurrent
71399-8627-271399862702120 TABLET, COATED in 1 BOTTLE (71399-8627-2) 2021-05-120000-00-00NoNoCurrent