TheraBreath for Kids Anticavity Strawberry Splash

Product NDC
10237-256
11-digit product format
102370256
Labeler code
10237
Product ID
10237-256_4477ea94-1abc-9fed-e063-6294a90a7cd4
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
2023-01-01
Substance
SODIUM FLUORIDE
Active strength
.5 mg/mL
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 for Kids Anticavity Strawberry Splash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 mg/mL

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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
578f8010-6b1c-4c6b-91d3-e483ace40f66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-256-10TheraBreath for Kids Anticavity Strawberry Splash296 mL in 1 BOTTLE, PLASTICRINSE2964
10237-256-16TheraBreath for Kids Anticavity Strawberry Splash473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-256-26TheraBreath for Kids Anticavity Strawberry Splash473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-256-26TheraBreath for Kids Anticavity Strawberry Splash2 in 1 PACKAGERINSE24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-256THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON (SODIUM FLUORIDE) RINSE THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH (SODIUM FLUORIDE) RINSE THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20250216_578f8010-6b1c-4c6b-91d3-e483ace40f66.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 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact identifier
application number: M021
Just For KidsSTANNOUS FLUORIDESolventum US LLC0f1afc36-f699-4072-b90b-c9f5be989a492024-08-01WarningsExact identifier
application number: M021
Clinpro Tooth CremeSODIUM FLUORIDESolventum US LLC786c6184-6bc8-4376-9ce2-3e35af1932102024-08-01WarningsExact identifier
application number: M021
PerioMedSTANNOUS FLUORIDESolventum US LLC7f79eb00-86df-4284-b415-47f45e4849da2024-08-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN578f8010-6b1c-4c6b-91d3-e483ace40f664
240698sodium fluoride 0.5 MG/ML MouthwashSCD578f8010-6b1c-4c6b-91d3-e483ace40f664
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY578f8010-6b1c-4c6b-91d3-e483ace40f664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-256-1010237025610296 mL in 1 BOTTLE, PLASTIC (10237-256-10) 296 ml2023-01-010000-00-00NoNoCurrent
10237-256-1610237025616473 mL in 1 BOTTLE, PLASTIC (10237-256-16) 473 ml2023-03-30NoNoCurrent
10237-256-26102370256262 BOTTLE, PLASTIC in 1 PACKAGE (10237-256-26) / 473 mL in 1 BOTTLE, PLASTIC2025-09-01NoNoCurrent