FDA.reportPublic FDA data

Therabreath

Product NDC
10237-271
Requested package NDC
10237-271-07
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 26 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc5d5bc17-e81b-34aa-e053-2a95a90ad77f2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960fef18-4533-5250-e053-2995a90aaf762026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance BlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d9a1754-8d38-054f-e053-2991aa0a46532026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
application number: M021
Crest Gum Detoxify plus WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company63779942-0f6c-11c5-e053-2991aa0a25ab2026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Sensitivity Active FoamSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Companyb8535d1c-cf15-f353-e053-2a95a90a79742026-01-08WarningsExact identifier
application number: M021
Burts Bees Extra White Zen PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Company81279e1f-6224-8114-e053-2991aa0aab082026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Advanced Whitening Fresh MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyc8350ab3-9347-58c0-e053-2995a90a72382026-01-08Exact identifier
application number: M021
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyddcb0871-9900-125f-e053-2a95a90a75de2026-01-08Exact identifier
application number: M021
Burts Bees Deep Clean plus WhiteningSODIUM FLUORIDEProcter & Gamble Manufacturing Companyc924b8dd-8d84-1329-e053-2995a90a45312026-01-08WarningsExact identifier
application number: M021
Crest Plus Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company07ed767e-225c-e9c5-e063-6394a90af9312026-01-08WarningsExact identifier
application number: M021
Crest Plus Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company0813171e-bda5-b004-e063-6394a90ad3642026-01-08WarningsExact identifier
application number: M021
Burts Bees Kids Strawberry SplashSODIUM FLUORIDEProcter & Gamble Manufacturing Company087b3434-2636-74ce-e063-6394a90a25ad2026-01-08WarningsExact 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
10237-271-07102370271071 TUBE in 1 CARTON (10237-271-07) / 19 g in 1 TUBE1 tube2025-09-15NoNoCurrent