Colgate Optic White Stain Fighter

Product NDC
35000-809
11-digit product format
350000809
Labeler code
35000
Product ID
35000-809_6b8c76b7-89f3-4e27-91cb-c4bb2f06aaed
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
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 Optic White Stain Fighter
Brand name suffix
With Baking Soda
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
8e6113e2-101b-4bde-90e9-6ab32c6ebf5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-809-42Colgate Optic White Stain FighterWith Baking Soda1 in 1 CARTONPASTE, DENTIFRICE16
35000-809-42Colgate Optic White Stain FighterWith Baking Soda119 g in 1 TUBEPASTE, DENTIFRICE1196
35000-809-60Colgate Optic White Stain FighterWith Baking Soda170 g in 1 TUBEPASTE, DENTIFRICE1706
35000-809-60Colgate Optic White Stain FighterWith Baking Soda1 in 1 CARTONPASTE, DENTIFRICE16
35000-809-63Colgate Optic White Stain FighterWith Baking Soda85 g in 1 TUBEPASTE, DENTIFRICE856
35000-809-63Colgate Optic White Stain FighterWith Baking Soda1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-809COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]5Current NDC, Legacy NDC, 6 package rows20241225_8e6113e2-101b-4bde-90e9-6ab32c6ebf5c.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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Space Jam Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company54cbfb09-8fd7-ef08-99fd-14fc019c81ff2024-11-14WarningsExact identifier
application number: M021
Colgate Kids Llama Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolivea7b02cb2-cfb3-7b35-42da-7924d156dcc32024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Clean MintSODIUM FLUORIDEColgate-Palmolive Company82bc1101-84d7-4e21-be9c-870ad88a4b7c2024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDECOLGATE PALMOLIVE COMPANYb6ca4ec7-5087-4693-82b7-199b44d7f9312024-11-13WarningsExact identifier
application number: M021
Listerine Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
application number: M021
Listerine Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLCee9a962d-83c7-4b13-bff6-140e48785e8a2024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint ShieldSODIUM FLUORIDEKenvue Brands LLCd69d2e0d-a3e3-4d95-992d-c0c59172b3a52024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDELG H&H Co.,Ltd.2697fa68-b991-ab09-e063-6394a90aec4c2024-11-01WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.2698d6d8-051b-6c10-e063-6394a90a94182024-11-01WarningsExact identifier
application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)SODIUM FLUORIDEMADE BY DENTISTS INC263c448b-728f-4370-bcdb-148d614d9b342024-10-30WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.17f589e9-f4ba-46d3-a345-db38f9a9067d2024-10-17WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
application number: M021
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
application number: M021
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDENavajo Manufacturing Company Inc.23851360-e30e-dd97-e063-6394a90a54742024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN8e6113e2-101b-4bde-90e9-6ab32c6ebf5c6
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD8e6113e2-101b-4bde-90e9-6ab32c6ebf5c6
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY8e6113e2-101b-4bde-90e9-6ab32c6ebf5c6
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY8e6113e2-101b-4bde-90e9-6ab32c6ebf5c6
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY8e6113e2-101b-4bde-90e9-6ab32c6ebf5c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-809-10350000809101 TUBE in 1 CARTON (35000-809-10) / 164 g in 1 TUBE1 tube2026-04-01NoNoCurrent
35000-809-42350000809421 TUBE in 1 CARTON (35000-809-42) / 119 g in 1 TUBE1 tube2023-01-012027-11-01NoNoCurrent
35000-809-59350000809591 TUBE in 1 CARTON (35000-809-59) / 107 g in 1 TUBE1 tube2025-11-07NoNoCurrent
35000-809-60350000809601 TUBE in 1 CARTON (35000-809-60) / 170 g in 1 TUBE1 tube2023-01-012027-12-01NoNoCurrent
35000-809-63350000809631 TUBE in 1 CARTON (35000-809-63) / 85 g in 1 TUBE1 tube2024-05-28NoNoCurrent