FDA.reportPublic FDA data

TheraBreath Kids Anticavity Oral Rinse Bubblegum

Product NDC
10237-266
11-digit product format
102370266
Labeler code
10237
Product ID
10237-266_4b814b9e-2b42-781e-e063-6294a90a2179
Type
HUMAN OTC DRUG
Nonproprietary name
Anticavity Oral Rinse
Dosage form
RINSE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-31
Substance
SODIUM FLUORIDE
Active strength
.005 mg/10mL
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 Kids Anticavity Oral Rinse Bubblegum
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
2770424d-7416-66d4-e063-6394a90ad4b1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-266-10TheraBreath Kids Anticavity Oral Rinse Bubblegum296 mL in 1 BOTTLERINSE2962
10237-266-16TheraBreath Kids Anticavity Oral Rinse Bubblegum473 mL in 1 BOTTLERINSE4732
10237-266-26TheraBreath Kids Anticavity Oral Rinse Bubblegum473 mL in 1 BOTTLERINSE4732
10237-266-26TheraBreath Kids Anticavity Oral Rinse Bubblegum2 in 1 PACKAGERINSE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-266THERABREATH KIDS ANTICAVITY ORAL RINSE BUBBLEGUM (ANTICAVITY ORAL RINSE) RINSE [CHURCH & DWIGHT CO., INC.]1Current NDC, 4 package rows20250101_2770424d-7416-66d4-e063-6394a90ad4b1.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 13 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYS Silver Sensitive Mouth Rinse Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.98a8cee8-9f3c-4a4a-89f8-72e1f1b067962026-04-01WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-266-1010237026610296 mL in 1 BOTTLE (10237-266-10) 296 ml2024-12-31NoNoCurrent
10237-266-1610237026616473 mL in 1 BOTTLE (10237-266-16) 473 ml2024-12-31NoNoCurrent
10237-266-26102370266262 BOTTLE in 1 PACKAGE (10237-266-26) / 473 mL in 1 BOTTLE2 bottle2026-02-06NoNoCurrent