FDA.reportPublic FDA data

Aspirin

Product NDC
68788-8256
Requested package NDC
68788-8256-3
11-digit product format
687888256
Labeler code
68788
Product ID
68788-8256_9a0d19c8-9aa2-4cce-baa7-7f03b2011ef7
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
343
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-16
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

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
68788-8256-1Aspirin100 in 1 BOTTLETABLET1005
68788-8256-2Aspirin20 in 1 BOTTLETABLET205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8256-1EA - Each68788-8256733fd40a-1d96-40de-bbbe-04cca20a478612022-10-06
68788-8256-2EA - Each68788-82567e1a88bb-3960-41ba-b684-729f0afdc9e612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8256ASPIRIN TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20250206_b0e260a2-4e86-479a-b17b-60324694f669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSNb0e260a2-4e86-479a-b17b-60324694f6695
212033aspirin 325 MG Oral TabletSCDb0e260a2-4e86-479a-b17b-60324694f6695
212033ASA 325 MG Oral TabletSYb0e260a2-4e86-479a-b17b-60324694f6695

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8256-36878882560330 TABLET in 1 BOTTLE (68788-8256-3) 30 tablet2022-09-23NoNoCurrent