FDA.reportPublic FDA data

Acetylsalicylic Acid

Manufacturer
4Medical Group, LLC | Allegiant Health
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:52:37

Label at a glance#

ProductAcetylsalicylic Acid Coated
Active ingredientASPIRIN
Label structure1 sections

Label contents#

Full prescribing information#

4Medical Acetylsalicylic Acid 81mg - NDC: 83337-252-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4Medical Acetylsalicylic Acid4Medical Acetylsalicylic AcidBox Acetylsalicylic Acid - 4MedicalGroup. PC 252 - SPC 372Box Acetylsalicylic Acid - 4MedicalGroup. PC 252 - SPC 372Box Acetylsalicylic Acid - 4MedicalGroup. PC 252 - SPC 372

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7
308416aspirin 81 MG Delayed Release Oral TabletSCD7
308416ASA 81 MG Delayed Release Oral TabletSY7
308416aspirin 81 MG Enteric Coated Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83337-252-242024-01-30C16284748780-11030e364-fd9a-111a-e063-dadaa90a10e2030fb565-2006-a4c3-e063-6394a90a3505

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83337-252-24Acetylsalicylic AcidCoated40 in 1 BOXTABLET407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83337-252ACETYLSALICYLIC ACID COATED (ASPIRIN) TABLET [4MEDICAL GROUP, LLC]71 package rows20250116_030fb565-2006-a4c3-e063-6394a90a3505.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83337-25283337-252-24
69168-372

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
CROSPOVIDONE2S7830E561IACT
METHACRYLIC ACID1CS02G8656IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ASPIRINR16CO5Y76EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2bbffad1-45b7-928a-e063-6394a90a6f2c030fb565-2006-a4c3-e063-6394a90a35052025-01-15Exact identifier
spl id: 2bbffad1-45b7-928a-e063-6394a90a6f2c
spl set id: 030fb565-2006-a4c3-e063-6394a90a3505
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
ndc (product): 69168-372

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.