FDA.reportPublic FDA data

Aspirin

Product NDC
68788-8256
11-digit product format
687888256
Labeler code
68788
Product ID
68788-8256_e4df6c96-5b64-4ad8-ab2d-7f1d5f155b91
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
212033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0e260a2-4e86-479a-b17b-60324694f669Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINPreferred Pharmaceuticals Inc.b0e260a2-4e86-479a-b17b-60324694f6692026-03-09WarningsExact identifier
ndc (product): 68788-8256

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 startMarketing endSampleExclude flagStatus
68788-8256-168788825601100 TABLET in 1 BOTTLE (68788-8256-1) 100 tablet2022-09-160000-00-00NoNoCurrent
68788-8256-26878882560220 TABLET in 1 BOTTLE (68788-8256-2) 20 tablet2022-09-160000-00-00NoNoCurrent