FDA.reportPublic FDA data

Acido Acetilsalicilico

Manufacturer
4Medical Group LLC
Effective date
2023-07-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:29

Label at a glance#

ProductAcido Acetilsalicilico With enteric coat
Active ingredientASPIRIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspiring 81mg NDC 83337-232Aspiring 81mg NDC 83337-232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN3
308416aspirin 81 MG Delayed Release Oral TabletSCD3
308416ASA 81 MG Delayed Release Oral TabletSY3
308416aspirin 81 MG Enteric Coated Oral TabletSY3

DailyMed Pharmacologic Classes#

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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83337-232-242025-01-30C16284748780-11030e365-5c3f-111a-e063-dadaa90a10e2OTC Label - Aspirin - Allegiant Health
83337-232-242024-01-30C16284748780-11030e365-5c3f-111a-e063-dadaa90a10e2OTC Label - Aspirin - Allegiant Health

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83337-232-24Acido AcetilsalicilicoWith enteric coat40 in 1 BOXTABLET, COATED403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83337-232ACIDO ACETILSALICILICO WITH ENTERIC COAT (ASPIRIN) TABLET, COATED [4MEDICAL GROUP LLC]31 package rows20230708_f783afa1-e1aa-c686-e053-6294a90a3354.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83337-23283337-232-24
69168-405

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
BROWN IRON OXIDE1N032N7MFOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDRIDE23J3BHR95OIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
ASPIRINR16CO5Y76EACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT

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
ffdb39ca-51a5-2267-e053-6394a90adf3ff783afa1-e1aa-c686-e053-6294a90a33542023-07-06Exact identifier
spl id: ffdb39ca-51a5-2267-e053-6394a90adf3f
spl set id: f783afa1-e1aa-c686-e053-6294a90a3354
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINAllegiant Healthd6c7c8c9-b997-4acc-a066-133bfb1239cb2021-11-02WarningsExact identifier
ndc (product): 69168-405

Reported adverse events (FAERS/openFDA)#

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