FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
68196-481
11-digit product format
681960481
Labeler code
68196
Product ID
68196-481_19976fb1-a961-164d-e063-6294a90a6e57
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
SAM'S WEST INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68196-481-70Low Dose Aspirin2 in 1 CARTONTABLET, COATED22
68196-481-70Low Dose Aspirin365 in 1 BOTTLETABLET, COATED3652

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-481LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [SAM'S WEST INC]2Current NDC, 2 package rows20240701_16595d62-8507-103c-e063-6394a90a491a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN16595d62-8507-103c-e063-6394a90a491a2
308416aspirin 81 MG Delayed Release Oral TabletSCD16595d62-8507-103c-e063-6394a90a491a2
308416ASA 81 MG Delayed Release Oral TabletSY16595d62-8507-103c-e063-6394a90a491a2
308416aspirin 81 MG Enteric Coated Oral TabletSY16595d62-8507-103c-e063-6394a90a491a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-481-70681960481702 BOTTLE in 1 CARTON (68196-481-70) / 365 TABLET, COATED in 1 BOTTLE2 bottle2024-07-01NoNoHistorical