FDA.reportPublic FDA data

ASPIRIN 325 MG EC

Product NDC
69618-015
11-digit product format
696180015
Labeler code
69618
Product ID
69618-015_2bc81112-204e-2514-e063-6394a90a80ed
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
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
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 325 MG EC
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
2ab8564f-f958-7512-e054-00144ff88e88Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69618-015-012023-03-29ASPIRIN 325 MG EC TABLET
69618-015-102023-03-29ASPIRIN 325 MG EC TABLET
69618-015-012023-01-30ASPIRIN 325 MG EC TABLET
69618-015-102023-01-30ASPIRIN 325 MG EC TABLET

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-015-01ASPIRIN 325 MG EC100 in 1 BOTTLE, PLASTICTABLET1006
69618-015-10ASPIRIN 325 MG EC1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-015-01EA - Each69618-015296184d8-b7d1-4a4a-b254-1207752766ee12016-03-04
69618-015-10EA - Each69618-01534634cc6-a414-446f-891f-aba33a29692e12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-015ASPIRIN 325 MG EC (ASPIRIN) TABLET [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250117_2ab8564f-f958-7512-e054-00144ff88e88.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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN9d0449d2-c0c6-4e74-931b-35dc62584028102
198467aspirin 325 MG Delayed Release Oral TabletSCD9d0449d2-c0c6-4e74-931b-35dc62584028102
198467ASA 325 MG Delayed Release Oral TabletSY9d0449d2-c0c6-4e74-931b-35dc62584028102
198467aspirin 325 MG Enteric Coated Oral TabletSY9d0449d2-c0c6-4e74-931b-35dc62584028102
198467aspirin 325 MG Delayed Release Oral TabletPSN9f9355f7-024a-4adc-bb4c-2d9c0dd0cb777
198467aspirin 325 MG Delayed Release Oral TabletSCD9f9355f7-024a-4adc-bb4c-2d9c0dd0cb777
198467ASA 325 MG Delayed Release Oral TabletSY9f9355f7-024a-4adc-bb4c-2d9c0dd0cb777
198467aspirin 325 MG Enteric Coated Oral TabletSY9f9355f7-024a-4adc-bb4c-2d9c0dd0cb777
198467aspirin 325 MG Delayed Release Oral TabletPSN2ab8564f-f958-7512-e054-00144ff88e886
198467aspirin 325 MG Delayed Release Oral TabletSCD2ab8564f-f958-7512-e054-00144ff88e886
198467ASA 325 MG Delayed Release Oral TabletSY2ab8564f-f958-7512-e054-00144ff88e886
198467aspirin 325 MG Enteric Coated Oral TabletSY2ab8564f-f958-7512-e054-00144ff88e886
198467aspirin 325 MG Delayed Release Oral TabletPSNac25f45a-bfa6-71ce-e053-2a95a90a02ec1
198467aspirin 325 MG Delayed Release Oral TabletSCDac25f45a-bfa6-71ce-e053-2a95a90a02ec1
198467ASA 325 MG Delayed Release Oral TabletSYac25f45a-bfa6-71ce-e053-2a95a90a02ec1
198467aspirin 325 MG Enteric Coated Oral TabletSYac25f45a-bfa6-71ce-e053-2a95a90a02ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-015-0169618001501100 TABLET in 1 BOTTLE, PLASTIC (69618-015-01) 100 tablet2015-11-010000-00-00NoNoCurrent
69618-015-10696180015101000 TABLET in 1 BOTTLE, PLASTIC (69618-015-10) 1000 tablet2015-11-010000-00-00NoNoCurrent