FDA.reportPublic FDA data

Aspirin

Product NDC
80425-0293
Requested package NDC
80425-0293-2
11-digit product format
804250293
Labeler code
80425
Product ID
80425-0293_2a9b9724-0259-e829-e063-6394a90a1c07
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-27
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
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
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
f8375029-e567-c6a5-e053-6394a90a5b67Available 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
80425-0293-1Aspirin30 in 1 BOTTLETABLET, COATED302
80425-0293-2Aspirin60 in 1 BOTTLETABLET, COATED602
80425-0293-3Aspirin90 in 1 BOTTLETABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0293-1EA - Each80425-0293a7221cf1-d4c2-4927-8974-85d32c9879ad12023-06-06
80425-0293-2EA - Each80425-029328cb4c04-c6fc-4fb9-bb93-ba77ded1662b12023-06-06
80425-0293-3EA - Each80425-02933c9e6a74-ab42-4fa5-b164-95ca1db8d56d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0293ASPIRIN TABLET, COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f8375029-e567-c6a5-e053-6394a90a5b67.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 68 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Childrens Pain and FeverACETAMINOPHENAmerisource Bergen074fdf65-f6ce-46d4-87cc-46911c01cca52024-05-23WarningsExact identifier
application number: M013
DG Health Childrens Pain and FeverACETAMINOPHENDolgencorp, LLC779cf607-245f-408a-81e8-8000c0ea4c4a2024-05-22WarningsExact identifier
application number: M013
good sense pain and fever infantsACETAMINOPHENL. Perrigo Company7b4c7e4c-1536-45ab-a59b-4d5dd8eb2eb42024-05-21WarningsExact identifier
application number: M013
Extra Strength Night Time Pain MedicineACETAMINOPHEN, DIPHENHYDRAMINE HCLGeri-Care Pharmaceutical Corp2b8f83ed-1ca9-49ac-9b2a-2609b68200f92024-05-21WarningsExact identifier
application number: M013
Acetaminophen SolutionACETAMINOPHENPatrin Pharma, Inc.52ae729b-2255-420c-8db8-cabdc2b747962024-05-21WarningsExact identifier
application number: M013
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2f9da3d6-229d-44d1-bd94-4bcddbbdb1202024-05-20WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS07d34e7a-c0c6-f3c4-e063-6294a90aa5c32024-05-18WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutionsbcb7eb24-16cb-439e-879f-48d2f5e8ba832024-05-17WarningsExact identifier
application number: M013
Basic Care Childrens Pain and FeverACETAMINOPHENAmazon.com Services LLC26266777-185d-4110-a8a7-56846aab25422024-05-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENA-S Medication Solutions1b4db77f-b254-4db5-8e98-d46850140a9b2024-05-16WarningsExact identifier
application number: M013
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
application number: M013
Kosher Meds Childrens Allergy ReliefDIPHENHYDRAMINE HCLMollec Inc42ad618b-d2e5-4c58-9407-386df4fe40042024-05-15WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENP & L Development, LLC1c081a7c-8cff-4253-97ac-5fa74a5c06682024-05-10WarningsExact identifier
application number: M013
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc1d794621-9836-4ab8-92ee-fcd9169645672024-05-09WarningsExact identifier
application number: M013
Aspirin 81mg Dye-FreeASPIRIN 81MGAllegiant Health26ad090d-7193-45c2-82eb-a2bc81955fe62024-05-08WarningsExact identifier
application number: M013
basic care infants pain and feverACETAMINOPHENAmazon.com Services LLC40329d8c-eb3d-4143-b4ae-9bafd0a1cb3c2024-05-08WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENWalgreen Company928bb80e-2e14-488c-99ab-abb860cbe7a82024-05-07WarningsExact identifier
application number: M013
basic care childrens pain and feverACETAMINOPHENAmazon.com Services LLC790d8883-52be-46f2-9838-564b6c5d57f92024-05-07WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSNf8375029-e567-c6a5-e053-6394a90a5b672
198467aspirin 325 MG Delayed Release Oral TabletSCDf8375029-e567-c6a5-e053-6394a90a5b672
198467ASA 325 MG Delayed Release Oral TabletSYf8375029-e567-c6a5-e053-6394a90a5b672
198467aspirin 325 MG Enteric Coated Oral TabletSYf8375029-e567-c6a5-e053-6394a90a5b672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0293-28042502930260 TABLET, COATED in 1 BOTTLE (80425-0293-2) 2023-04-27NoNoCurrent