FDA.reportPublic FDA data

ULINE Aspirin

Product NDC
69790-616
11-digit product format
697900616
Labeler code
69790
Product ID
69790-616_3e5d8d3a-9171-38b3-e063-6394a90aa024
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ULINE
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-20
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
2026-12-31
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
ULINE Aspirin
Listing expiration
2026-12-31

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
9b2b053c-11e7-8169-e053-2995a90ae336Available 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
69790-616-33ULINE Aspirin2 in 1 PACKETTABLET, FILM COATED28
69790-616-33ULINE Aspirin50 in 1 BOXTABLET, FILM COATED508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69790-616ULINE ASPIRIN (ASPIRIN) TABLET, COATED ULINE ASPIRIN (ASPIRIN) TABLET, FILM COATED [ULINE]7Current NDC, Legacy NDC, 2 package rows20240829_9b2b053c-11e7-8169-e053-2995a90ae336.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 32 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC422796ed-7558-f7e8-e063-6294a90ad1c72025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e61abe4-b4be-01af-e063-6394a90a8b242025-11-20WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
application number: M013
ASPIRINASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED54e4ae54-caf8-4105-8428-256f56a2f68f2025-11-19WarningsExact identifier
application number: M013
MIDOL COMPLETEACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATER J General Corporation0c09a178-1a07-4079-b4a6-d1657cb8e7142025-11-17WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
application number: M013
MOTRIN IBIBUPROFENR J General Corporationafa87bb5-7fcb-4ccd-acac-f7931242181f2025-11-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENR J General Corporation99e45e83-37a3-44df-9a2a-98ba7457a5bb2025-11-17WarningsExact identifier
application number: M013
TYLENOL PM EXTRA STRENGTHACETAMINOPHENR J General Corporationa40ea0e3-d666-4605-b5e0-beeaf8f586f22025-11-17WarningsExact identifier
application number: M013
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MGR J General Corporation68d3be55-9340-4cc9-a05a-12b9338ddc562025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationdd9aaf80-6c2b-41a3-87b9-61642aaed4f02025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c18a2da-1718-4c00-aea8-9fb4a34183122025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationcd3060a5-3b90-42e4-89cd-3b620859045f2025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c7221ae-52d1-4d18-b586-c47ff656150d2025-11-17WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINER J General Corporation907c89e7-2482-465f-9f85-2381ecab1b862025-11-17WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINR J General Corporation23daa359-d40f-4f64-81be-6d154f41df9f2025-11-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN9b2b053c-11e7-8169-e053-2995a90ae3368
212033aspirin 325 MG Oral TabletSCD9b2b053c-11e7-8169-e053-2995a90ae3368
212033ASA 325 MG Oral TabletSY9b2b053c-11e7-8169-e053-2995a90ae3368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69790-616-336979006163350 PACKET in 1 BOX (69790-616-33) / 2 TABLET, FILM COATED in 1 PACKET50 packet2020-07-200000-00-00NoNoCurrent