FDA.reportPublic FDA data

Aspirin

Product NDC
69396-158
11-digit product format
693960158
Labeler code
69396
Product ID
69396-158_503b1a8c-ed32-c93b-e063-6394a90a4a82
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-24
Substance
ASPIRIN
Active strength
325 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui212033

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
69396-158-01Aspirin2 in 1 PACKETTABLET23
69396-158-01Aspirin50 in 1 BOXTABLET503
69396-158-05Aspirin2 in 1 PACKETTABLET23
69396-158-05Aspirin10000 in 1 BAGTABLET100003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-158ASPIRIN TABLET [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 4 package rows20240926_227cefca-acc4-41d0-e063-6394a90a35b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN227cefca-acc4-41d0-e063-6394a90a35b93
212033aspirin 325 MG Oral TabletSCD227cefca-acc4-41d0-e063-6394a90a35b93
212033ASA 325 MG Oral TabletSY227cefca-acc4-41d0-e063-6394a90a35b93
212033aspirin 325 MG Oral TabletPSN2ef0757a-fe5f-47de-906a-a4d47a0d05341
212033aspirin 325 MG Oral TabletSCD2ef0757a-fe5f-47de-906a-a4d47a0d05341
212033ASA 325 MG Oral TabletSY2ef0757a-fe5f-47de-906a-a4d47a0d05341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-158-016939601580150 PACKET in 1 BOX (69396-158-01) / 2 TABLET in 1 PACKET50 packet2024-08-24NoNoCurrent
69396-158-056939601580510000 PACKET in 1 BAG (69396-158-05) / 2 TABLET in 1 PACKET10000 packet2024-08-24NoNoCurrent