FDA.reportPublic FDA data

Aspirin

Product NDC
10135-729
11-digit product format
101350729
Labeler code
10135
Product ID
10135-729_3ba085f8-2eeb-8958-e063-6394a90a7739
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-729-10Aspirin1000 in 1 BOTTLETABLET10005
10135-729-62Aspirin120 in 1 BOTTLETABLET1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-729-10EA - Each10135-729671d5b61-cff4-4ea4-9724-3286481f8e9512025-09-12
10135-729-62EA - Each10135-7290aeb499d-1f9b-4794-956c-be29269cedce12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-729ASPIRIN TABLET [MARLEX PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20241004_cc7013ea-cf30-6f59-e053-2a95a90a1148.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNcc7013ea-cf30-6f59-e053-2a95a90a11485
308416aspirin 81 MG Delayed Release Oral TabletSCDcc7013ea-cf30-6f59-e053-2a95a90a11485
308416ASA 81 MG Delayed Release Oral TabletSYcc7013ea-cf30-6f59-e053-2a95a90a11485
308416aspirin 81 MG Enteric Coated Oral TabletSYcc7013ea-cf30-6f59-e053-2a95a90a11485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-729-10101350729101000 TABLET in 1 BOTTLE (10135-729-10) 1000 tablet2025-08-05NoNoHistorical
10135-729-6210135072962120 TABLET in 1 BOTTLE (10135-729-62) 120 tablet2021-09-010000-00-00NoNoCurrent