FDA.reportPublic FDA data

LOW DOSE ASPIRIN

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-02-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:10

Label at a glance#

ProductLOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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
68071-4449-12023-01-30C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-32023-01-30C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-92023-01-30C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-12021-02-16C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-32021-02-16C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-92021-02-16C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-12021-01-29C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-32021-01-29C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0
68071-4449-92021-01-29C16284748780-1ba0f9c33-23f3-a910-e053-dadaa90a0b856d5b2167-8afc-7b71-e053-2991aa0aedf0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4449-1LOW DOSE ASPIRIN100 in 1 BOTTLETABLET, COATED1003
68071-4449-3LOW DOSE ASPIRIN30 in 1 BOTTLETABLET, COATED303
68071-4449-9LOW DOSE ASPIRIN90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4449LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20210217_6d5b2167-8afc-7b71-e053-2991aa0aedf0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-481-10EA - Each49483-48168c3b475-b23b-4a98-95f3-b88442ecc38e12017-06-15
49483-481-12EA - Each49483-4816d406952-771a-4b61-979e-0a5c9475bf6112017-06-15

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
68071-444968071-4449-3, 68071-4449-9, 68071-4449-1
49483-481

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
TRIETHYL CITRATE8Z96QXD6UMIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
POLYSORBATE 806OZP39ZG8HIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
ndc (product): 49483-481
bb7d7aef-92bc-2b6d-e053-2a95a90ad29d6d5b2167-8afc-7b71-e053-2991aa0aedf02021-02-16Exact identifier
spl id: bb7d7aef-92bc-2b6d-e053-2a95a90ad29d
spl set id: 6d5b2167-8afc-7b71-e053-2991aa0aedf0

Reported adverse events (FAERS/openFDA)#

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