FDA.reportPublic FDA data

Colgate

Product NDC
35000-903
Requested package NDC
35000-903-01
11-digit product format
350000903
Labeler code
35000
Product ID
35000-903_14f9feea-6d53-476e-84c5-4a6cabd5c0ac
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-01
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Max Fresh Cool Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00652bb2-090c-4eaa-8fc2-e0be6913a724Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-903-01ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-01ColgateMax Fresh Cool Mint28.3 g in 1 TUBEGEL, DENTIFRICE28.36
35000-903-58ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-58ColgateMax Fresh Cool Mint70 g in 1 TUBEGEL, DENTIFRICE706
35000-903-60ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-60ColgateMax Fresh Cool Mint170 g in 1 TUBEGEL, DENTIFRICE1706
35000-903-75ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-75ColgateMax Fresh Cool Mint79 g in 1 TUBEGEL, DENTIFRICE796
35000-903-78ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-78ColgateMax Fresh Cool Mint221 g in 1 TUBEGEL, DENTIFRICE2216
35000-903-95ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-95ColgateMax Fresh Cool Mint178 g in 1 TUBEGEL, DENTIFRICE1786
35000-903-99ColgateMax Fresh Cool Mint1 in 1 CARTONGEL, DENTIFRICE16
35000-903-99ColgateMax Fresh Cool Mint53 g in 1 TUBEGEL, DENTIFRICE536

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-903COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Current NDC, Legacy NDC, 14 package rows20241127_00652bb2-090c-4eaa-8fc2-e0be6913a724.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 34 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact identifier
application number: M021
Gerigentle-Good morningSODIUM FLORIDEGeri-Gentle Corporatione69b3767-00c5-a535-e053-2995a90ad2152025-10-23WarningsExact identifier
application number: M021
Hello Penguin ChillSODIUM FLUORIDEColgate-Palmolive Company5c47a7d5-da34-4658-8006-b36f6477cb9b2025-10-23WarningsExact identifier
application number: M021
Auraglow WhiteningSODIUM FLUORIDEAuraglow LLC9d45e436-92f6-4a9e-9b82-329847dca9ba2025-10-22WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyed20cf9d-6162-4337-bb0b-1a6a6e9e1dc32025-10-21WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitudede21b326-f885-464b-b2df-f3866a0b3e9a2025-10-20WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY00652bb2-090c-4eaa-8fc2-e0be6913a7246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-903-01350000903011 TUBE in 1 CARTON (35000-903-01) / 28.3 g in 1 TUBE1 tube2020-05-180000-00-00NoNoCurrent