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 24 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Premium Plus Deep Clean Active FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb851fe5c-d904-12da-e053-2a95a90a86f92026-01-08WarningsExact identifier
application number: M021
Crest Baking Soda and Peroxide Whitening with Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyadebbd47-011d-4cd3-a002-1eb67e885e5b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Stain ShieldSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c9b5ef-8dd4-a842-e053-2a95a90ad3872026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7baa77f5-fe45-6566-e053-2991aa0a381f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Vibrant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf63c3354-a264-8130-e053-2a95a90a20222026-01-08Exact identifier
application number: M021
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Luminous PurpleSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfbfcd837-4d88-5f82-e053-6394a90afbf62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
application number: M021
Crest 3D White Ultra Vivid MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companycba96ef0-0519-059f-e053-2a95a90a43ad2026-01-08WarningsExact identifier
application number: M021
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact 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