FDA.reportPublic FDA data

TCL 481R TABLETS

Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2020-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:00:00

Label at a glance#

ProductLOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure2 sections

Label contents#

Full prescribing information#

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 53002-1673

NDC: 53002-1673-0 1000 TABLET, COATED in a BOTTLE, PLASTIC

Aspirin 81mg EC-Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1673-02023-11-08C16284748780-1f386c649-f2f3-0266-e053-dadaa90a7c1aTCL 481R TABLETS
53002-1673-02023-01-30C16284748780-1f386c649-f2f3-0266-e053-dadaa90a7c1aTCL 481R TABLETS

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
53002-167353002-1673-0
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
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
TRIETHYL CITRATE8Z96QXD6UMIACT
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
c187fcf7-4682-4894-897f-cbc90d41a3f6e2e17e35-1146-409b-a5a1-c2a44ac2a0c82023-11-07WarningsExact identifier
spl set id: e2e17e35-1146-409b-a5a1-c2a44ac2a0c8

Reported adverse events (FAERS/openFDA)#

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