FDA.reportPublic FDA data

Aspirin 325 mg

Product NDC
69732-008
11-digit product format
697320008
Labeler code
69732
Product ID
69732-008_b70135a1-c94a-14e1-e053-2995a90a55b4
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Hi-Tech Nutraceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
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 325 mg
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
b3426a9a-ea99-da30-e053-2995a90a1e4bAvailable on FDA.report

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 41 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspi-CorASPIRINL.N.K. International, Inc.9f919a48-ffd8-49fa-b6fd-ec71cc12e64b2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack3d6bf733-800c-420a-a9ab-ae4a261347992025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions44b8c203-37c5-425e-9110-f7eb614f9c2d2025-08-08WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION INCc46688ec-e976-4f76-9265-645f59970ff52025-08-06WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLCc54ad829-f2e8-4367-b439-af20b0ef8ad22025-08-06WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
application number: M013
AspirinASPIRINMarlex Pharmaceuticals Inc.cc7013ea-cf30-6f59-e053-2a95a90a11482025-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3ba313db-bafe-1947-e063-6294a90a528c2025-08-05WarningsExact identifier
application number: M013
MEDIQUE APAP acetaminophenMEDIQUE APAP ACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst3ba5c802-fe5a-e42a-e063-6394a90ae67e2025-08-05WarningsExact identifier
application number: M013
meijer EXTRA STRENGTH Pain Relief PM CAPLETACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.376fed3b-7625-6379-e063-6394a90a188d2025-08-05WarningsExact identifier
application number: M013
CAREONE INFANTS ACETAMINOPHENACETAMINOPHENRetail Business Services, LLCb8024ec2-97c6-4aa1-b1dd-894164f488112025-08-04WarningsExact identifier
application number: M013
Exaprin PlusASPIRIN, ACETAMINOPHEN, CAFFEINEHART Health8a9ca680-e6cf-4ee4-8a5f-bd6d7470b8482025-08-04WarningsExact identifier
application number: M013
AspirinASPIRINProficient Rx LP2ef0757a-fe5f-47de-906a-a4d47a0d05342025-08-01WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENProficient Rx LPb4cb4a62-9ef7-4185-8770-e9a806c2fb3f2025-08-01WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad21a3-6229-e91b-e063-6394a90a79332025-07-29WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69732-008-0169732000801200 TABLET in 1 BOTTLE, PLASTIC (69732-008-01) 200 tablet2026-07-01NoNoCurrent