TheraBreath Fresh Breath Anticavity Mild Mint

Product NDC
10237-263
11-digit product format
102370263
Labeler code
10237
Product ID
10237-263_679b3591-0e35-4795-b75c-131588fefc34
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-08
Substance
SODIUM FLUORIDE
Active strength
.24 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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 Fresh Breath Anticavity Mild Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 g/100g

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
19ce5324-7d8d-4d70-ad9b-238f7e612eacAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
10237-263-04TheraBreath Fresh Breath Anticavity Mild Mint113.5 g in 1 TUBEPASTE, DENTIFRICE113.51
10237-263-04TheraBreath Fresh Breath Anticavity Mild Mint1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-263THERABREATH FRESH BREATH ANTICAVITY MILD MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1Current NDC, 2 package rows20240208_19ce5324-7d8d-4d70-ad9b-238f7e612eac.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 46 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum FlavorSODIUM FLUORIDEAshtel Studios Inc.bbf6cfe7-c5e5-4e63-ac7d-4535a0ca39732024-07-31WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.32780fe9-82bf-42f8-8218-bed5bc579c722024-07-30WarningsExact identifier
application number: M021
Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.7ba8cff2-92a4-4432-aaf3-50358d9483a22024-07-30WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.ed057c95-90cd-4edb-ac00-78db8f6a065b2024-07-29WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.f01c5eaf-7e81-4b30-bb6f-50566a7273642024-07-29WarningsExact identifier
application number: M021
Sodium MonofluorophosphateWHITE TOOTHPASTEDynarex Corporation1be422b9-6320-ed5c-e063-6294a90a7e422024-07-03WarningsExact identifier
application number: M021
Wpgcng Antiacvity Fluoride MouthwashSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.5756206e-43cc-8cc7-e063-6394a90a29502024-07-03WarningsExact identifier
application number: M021
dentalux Kids ANTI-CAVITY FLUORIDE Bubble GumSODIUM FLUORIDELidl US, LLC0c77ba33-acb9-4c83-aa75-7d5c82f903eb2024-07-02WarningsExact identifier
application number: M021
dentalux ANTI-CAVITY FLUORIDE WHITENING MINTSODIUM FLUORIDELidl US, LLC37011052-16ef-4ae4-aade-a86f9fa9cdac2024-07-02WarningsExact identifier
application number: M021
dentalux ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATELidl US, LLCccf54743-81c2-43f8-9c5c-d4baa85fc18d2024-07-02WarningsExact identifier
application number: M021
SmileSenseSTANNOUS FLUORIDESGII, INC1c371393-da75-c9c8-e063-6294a90a58402024-07-01WarningsExact identifier
application number: M021
Sodium FluorideCLEAR MINT, GEL TOOTHPASTEDynarex Corporation1be193b6-4c07-4f0a-e063-6394a90a32c72024-06-27WarningsExact identifier
application number: M021
CREST CAVITY PROTECTION COOL MINTSODIUM FLUORIDEA-S Medication Solutionsdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d2024-06-12WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.a37e9d9c-dca9-4d58-a716-4514ebe8ec882024-06-11WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVORSODIUM FLUORIDEAshtel Studios Inc.0e6b01a4-1132-489f-936c-d3a54e9e21e02024-06-11WarningsExact identifier
application number: M021
Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.ffb8c43c-8f45-42ec-83eb-f0c83f7f99f82024-06-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening ToothpasteSODIUM FLUORIDETai Guk Pharm. Co., Ltd.1a26ad70-9773-dc4f-e063-6294a90ac3332024-05-31WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening ToothpasteSODIUM FLUORIDELG H&H Co.,Ltd.1a01481f-3e02-634e-e063-6394a90ac5fc2024-05-31WarningsExact identifier
application number: M021
Brush Buddies - Hot Wheels ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.86dd5e9c-71c3-46ce-ae4c-45d19468667d2024-05-29WarningsExact identifier
application number: M021
Dentalclean Doctor Duck Kids Flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda18806738-82fa-1a37-e063-6294a90a38882024-05-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN19ce5324-7d8d-4d70-ad9b-238f7e612eac1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD19ce5324-7d8d-4d70-ad9b-238f7e612eac1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY19ce5324-7d8d-4d70-ad9b-238f7e612eac1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY19ce5324-7d8d-4d70-ad9b-238f7e612eac1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY19ce5324-7d8d-4d70-ad9b-238f7e612eac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-263-04102370263041 TUBE in 1 CARTON (10237-263-04) / 113.5 g in 1 TUBE1 tube2024-02-08NoNoCurrent