FDA.reportPublic FDA data

Therabreath Anticavity

Product NDC
10237-260
11-digit product format
102370260
Labeler code
10237
Product ID
10237-260_53d7150b-d8de-145c-e063-6394a90ac434
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-13
Substance
SODIUM FLUORIDE
Active strength
.005 mg/10mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10237-26010237-260-01DDiscontinued by firm2026-10-12

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 Anticavity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.005 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
feab3d45-ff95-4b32-8258-7d932a7380c9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-260-01Therabreath Anticavity1000 mL in 1 BOTTLE, PLASTICRINSE10004
10237-260-03Therabreath Anticavity88.7 mL in 1 BOTTLE, PLASTICRINSE88.74
10237-260-16Therabreath Anticavity473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-260-26Therabreath Anticavity2 in 1 PACKAGERINSE24
10237-260-26Therabreath Anticavity473 mL in 1 BOTTLERINSE4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-260THERABREATH ANTICAVITY (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]3Current NDC, 5 package rows20241109_feab3d45-ff95-4b32-8258-7d932a7380c9.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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEDONG IL PHARMS CO.,LTD3fb1a2ee-381e-a9e8-e063-6394a90a864b2025-09-26WarningsExact identifier
application number: M021
unpa Cha Cha ToothpasteSODIUM MONOFLUOROPHOSPHATELycl Inc.230b3cf2-053a-4e8b-8d50-05bbc877faa82025-09-25WarningsExact identifier
application number: M021
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact identifier
application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.f70d378b-d4d6-454c-90a9-794459960c8c2025-09-17WarningsExact identifier
application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.26b9b2dd-7cb2-47c3-8bbb-94a48f02dd212025-09-16WarningsExact identifier
application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.3436532d-e078-4dbb-a823-b4542e9615342025-09-16WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
application number: M021
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
application number: M021
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
application number: M021
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
application number: M021
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.e911effb-d59f-4054-9501-803b64369ab42025-09-05WarningsExact identifier
application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc.fc794fe5-7135-4b2b-b002-a75908223f202025-08-13WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-260-01102370260011000 mL in 1 BOTTLE, PLASTIC1000 mlHistorical
10237-260-031023702600388.7 mL in 1 BOTTLE, PLASTIC (10237-260-03) 88.7 ml2023-02-13NoNoCurrent
10237-260-101023702601010 PACKET in 1 CARTON (10237-260-10) / 10 mL in 1 PACKET10 packet2026-06-01NoNoCurrent
10237-260-1610237026016473 mL in 1 BOTTLE, PLASTIC (10237-260-16) 473 ml2023-02-13NoNoCurrent
10237-260-201023702602020 POUCH in 1 CARTON (10237-260-20) / 10 mL in 1 POUCH20 pouch2026-06-01NoNoCurrent
10237-260-26102370260262 BOTTLE in 1 PACKAGE (10237-260-26) / 473 mL in 1 BOTTLE2 bottle2025-05-28NoNoCurrent