FDA.reportPublic FDA data

COLGATE 2IN1

Product NDC
35000-927
Requested package NDC
35000-927-81
11-digit product format
350000927
Labeler code
35000
Product ID
35000-927_10b39656-1a49-42e2-a559-93c035c1b2f4
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-26
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-92735000-927-81DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-927-81COLGATE 2IN1ICY BLAST130 g in 1 BOTTLEGEL, DENTIFRICE1303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-927COLGATE 2IN1 ICY BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Legacy NDC, 1 package rows20241215_6aad9a91-ba1c-4a27-9269-ea8032feaad0.zip

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
COLGATE 2IN1 ICY BLASTSODIUM FLUORIDEColgate-Palmolive Company6aad9a91-ba1c-4a27-9269-ea8032feaad02026-08-26WarningsExact identifier
ndc (package): 35000-927-81
ndc (product): 35000-927
ndc11 (package): 35000092781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN6aad9a91-ba1c-4a27-9269-ea8032feaad03
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD6aad9a91-ba1c-4a27-9269-ea8032feaad03
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY6aad9a91-ba1c-4a27-9269-ea8032feaad03
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY6aad9a91-ba1c-4a27-9269-ea8032feaad03
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY6aad9a91-ba1c-4a27-9269-ea8032feaad03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-927-8135000092781130 g in 1 BOTTLE (35000-927-81) 130 g2016-08-110000-00-00NoNoCurrent