FDA.reportPublic FDA data

Aspirin

Product NDC
46122-596
11-digit product format
461220596
Labeler code
46122
Product ID
46122-596_1bb432eb-f97e-4771-af70-c0c85c7af424
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-01
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
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
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3099892-a8cd-4574-a6f9-041e59e2feaeAvailable 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
46122-596-02Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE110
46122-596-02Aspirin125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-596-02EA - Each46122-596d336e980-a4f7-4c59-a956-8105db971e2612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-596ASPIRIN TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]9Current NDC, Legacy NDC, 2 package rows20250108_c3099892-a8cd-4574-a6f9-041e59e2feae.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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mg Low DoseASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED23b29044-6389-42ea-839a-5351557a6ce32026-04-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI07edcb31-d31d-4607-98c3-dcb1e062cc702026-04-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCee50c5ee-1a61-4efc-aca9-42d897d6a3b82026-04-22WarningsExact identifier
application number: M013
AspirinASPIRINCVS PHARMACY904a2b21-d911-40c3-9e4b-59543ea5be4f2026-04-22WarningsExact identifier
application number: M013
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINPreferred Pharmaceuticals Inc.ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e2026-04-20WarningsExact identifier
application number: M013
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
application number: M013
Aspirin NSAIDASPIRINValu Merchandisers Company0cc46a81-54c9-44b7-b384-79d25255eff22026-04-17WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNc3099892-a8cd-4574-a6f9-041e59e2feae10
198467aspirin 325 MG Delayed Release Oral TabletSCDc3099892-a8cd-4574-a6f9-041e59e2feae10
198467ASA 325 MG Delayed Release Oral TabletSYc3099892-a8cd-4574-a6f9-041e59e2feae10
198467aspirin 325 MG Enteric Coated Oral TabletSYc3099892-a8cd-4574-a6f9-041e59e2feae10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-596-02461220596021 BOTTLE, PLASTIC in 1 CARTON (46122-596-02) / 125 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-06-010000-00-00NoNoCurrent