FDA.reportPublic FDA data

Therabreath

Product NDC
10237-271
11-digit product format
102370271
Labeler code
10237
Product ID
10237-271_5cb8aa68-be0c-9332-e063-6294a90a0ee9
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
STANNOUS FLUORIDE
Active strength
.454 g/100g
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
Therabreath
Brand name suffix
Healthy Gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.454 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-271-04TherabreathHealthy Gums1 in 1 CARTONPASTE, DENTIFRICE11
10237-271-04TherabreathHealthy Gums113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-271-07TherabreathHealthy Gums19 g in 1 TUBEPASTE, DENTIFRICE191
10237-271-07TherabreathHealthy Gums1 in 1 CARTONPASTE, DENTIFRICE11
10237-271-24TherabreathHealthy Gums113 g in 1 TUBEPASTE, DENTIFRICE1131
10237-271-24TherabreathHealthy Gums2 in 1 CARTONPASTE, DENTIFRICE21

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 6 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEMKJ BRANDS LLC525662da-42be-eaa6-e063-6294a90af1102026-07-14WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEMKJ BRANDS LLC526acbdd-6531-692d-e063-6394a90ab9f12026-07-14WarningsExact identifier
application number: M021
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY3c3683f0-8047-a648-e063-6394a90a258f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-271-04102370271041 TUBE in 1 CARTON (10237-271-04) / 113 g in 1 TUBE1 tube2025-12-15NoNoCurrent
10237-271-07102370271071 TUBE in 1 CARTON (10237-271-07) / 19 g in 1 TUBE1 tube2025-09-15NoNoCurrent
10237-271-22102370271222 CARTON in 1 PACKAGE (10237-271-22) / 2 TUBE in 1 CARTON / 130 g in 1 TUBE2 carton2026-10-01NoNoCurrent
10237-271-24102370271242 TUBE in 1 CARTON (10237-271-24) / 113 g in 1 TUBE2 tube2025-08-01NoNoCurrent