FDA.reportPublic FDA data

Aspirin

Product NDC
77333-035
Requested package NDC
77333-035-20
11-digit product format
773330035
Labeler code
77333
Product ID
77333-035_50fc4202-32ea-7849-e063-6394a90a5a73
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-15
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
Brand name suffix
Enteric Coated, Regular Strength
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
10b9a1fc-70d1-44ea-a6de-5c1943e8fbaaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
77333-035-20AspirinEnteric Coated, Regular Strength150 in 1 BOXTABLET, DELAYED RELEASE1501
77333-035-25AspirinEnteric Coated, Regular Strength1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11

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 48 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c55aa-9932-0a55-e053-2a95a90a3d1e2025-02-10WarningsExact identifier
application number: M013
AeroTab Pain RelieverPAIN RELIEVERAero Healthcare40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f2025-02-10WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINTime-Cap Labs, Inc5fbd8bb3-46f9-4089-9a21-b6af97a061062025-02-08WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
application number: M013
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300dfbc-7137-79d1-e053-2995a90a636e2025-02-05WarningsExact identifier
application number: M013
Low dose aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300c30b-ab1a-a1b4-e053-2a95a90a12942025-02-05WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c3524-3e24-3410-e053-2995a90a73ed2025-01-30WarningsExact identifier
application number: M013
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENSb5a45daa-05b1-4d6d-e053-2995a90a84442025-01-30WarningsExact identifier
application number: M013
Aspirin 81ASPIRINWALGREENSd71a571e-e2ce-7e0a-e053-2a95a90a53e02025-01-30WarningsExact identifier
application number: M013
Regular strength aspirinASPIRINTARGET CORPORATIONe8c87ccb-8c0c-7830-e053-2995a90a88b72025-01-30WarningsExact identifier
application number: M013
Multi-Symptom Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATETARGET2368ac1b-d644-9908-e063-6394a90a4b892025-01-29WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Company28e275fb-d615-4725-998c-946fe1bfdc0c2025-01-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa1
198467aspirin 325 MG Delayed Release Oral TabletSCD10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa1
198467ASA 325 MG Delayed Release Oral TabletSY10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa1
198467aspirin 325 MG Enteric Coated Oral TabletSY10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77333-035-2077333003520150 BLISTER PACK in 1 BOX (77333-035-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-035-25) 150 blister pack2026-05-15NoNoCurrent