FDA.reportPublic FDA data

Aspirin 81mg Enteric Coated Tablets

Manufacturer
NewVue LLC
Effective date
2023-11-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:44

Label at a glance#

ProductAspirin 81 mg
Active ingredientASPIRIN
Label structure15 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: - are age 60 or older - have had stomach ulcers or bleeding problems - take a blood thinning (anticoagulant) or steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

INDICATIONS & USAGE SECTION

Pin Reliever

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 83813-001-01

AspirinAspirin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN1
308416aspirin 81 MG Delayed Release Oral TabletSCD1
308416ASA 81 MG Delayed Release Oral TabletSY1
308416aspirin 81 MG Enteric Coated Oral TabletSY1

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83813-001-012025-01-30C16284748780-12cef2736-99ed-d83d-e063-dadaa90ab31fAspirin 81mg Enteric Coated Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83813-001-01Aspirin 81 mg1000 in 1 BOTTLETABLET, DELAYED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83813-001ASPIRIN 81 MG (ASPIRIN ENTERIC COATED TABLETS 81 MG) TABLET, DELAYED RELEASE [NEWVUE LLC]11 package rows20231125_0adde1a9-1f82-7923-e063-6394a90a7f58.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83813-00183813-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIACETINXHX3C3X673IACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM LAURYL SULFATE368GB5141JIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)XRK36F13ZZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TALC7SEV7J4R1UIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
ASPIRINR16CO5Y76EACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0adde55f-f93a-71c5-e063-6394a90aa1bf0adde1a9-1f82-7923-e063-6394a90a7f582023-11-23WarningsExact identifier
spl id: 0adde55f-f93a-71c5-e063-6394a90aa1bf
spl set id: 0adde1a9-1f82-7923-e063-6394a90a7f58

Reported adverse events (FAERS/openFDA)#

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