FDA.reportPublic FDA data

COLGATE

Product NDC
35000-960
11-digit product format
350000960
Labeler code
35000
Product ID
35000-960_59ae8eda-bcf0-4f0a-baa0-7049a09a0914
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-96035000-960-64DDiscontinued by firm2026-10-16
excluded packagepackage35000-96035000-960-82DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
COLGATE
Brand name suffix
BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
263fef13-347b-489b-987d-933a63dbc900Available on FDA.report

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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-960-35350000960353 TUBE in 1 CARTON (35000-960-35) / 170 g in 1 TUBE3 tube2024-01-01NoNoCurrent
35000-960-60350000960601 TUBE in 1 CARTON (35000-960-60) / 170 g in 1 TUBE1 tube2020-01-010000-00-00NoNoCurrent
35000-960-64350000960641 TUBE in 1 CARTON (35000-960-64) > 181 g in 1 TUBE1 tube2011-08-200000-00-00NoNoCurrent
35000-960-69350000960691 TUBE in 1 CARTON (35000-960-69) / 113 g in 1 TUBE1 tube2020-01-010000-00-00NoNoCurrent
35000-960-82350000960821 TUBE in 1 CARTON (35000-960-82) > 232 g in 1 TUBE1 tube2011-08-200000-00-00NoNoCurrent