FDA.reportPublic FDA data

Therabreath Overnight Chamomile Mint

Product NDC
10237-262
11-digit product format
102370262
Labeler code
10237
Product ID
10237-262_45a8183b-aa06-ed02-e063-6394a90a46f5
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
2024-01-22
Substance
SODIUM FLUORIDE
Active strength
5 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Therabreath Overnight Chamomile Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-262-16Therabreath Overnight Chamomile Mint473 mL in 1 BOTTLE, PLASTICRINSE4734
10237-262-26Therabreath Overnight Chamomile Mint2 in 1 PACKAGERINSE24
10237-262-26Therabreath Overnight Chamomile Mint473 mL in 1 BOTTLE, PLASTICRINSE4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-262THERABREATH OVERNIGHT CHAMOMILE MINT (SODIUM FLUORIDE) RINSE [CHURCH & DWIGHT CO., INC.]2Current NDC, 3 package rows20241122_cc0c533c-145e-4877-b421-1baf3a3a572e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.5 MG/ML MouthwashSCDcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYcc0c533c-145e-4877-b421-1baf3a3a572e4
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN4618e390-9039-a1d0-e063-6294a90ab2941
240698sodium fluoride 0.5 MG/ML MouthwashSCD4618e390-9039-a1d0-e063-6294a90ab2941
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY4618e390-9039-a1d0-e063-6294a90ab2941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-262-1610237026216473 mL in 1 BOTTLE, PLASTIC (10237-262-16) 473 ml2024-01-22NoNoCurrent
10237-262-26102370262262 BOTTLE, PLASTIC in 1 PACKAGE (10237-262-26) / 473 mL in 1 BOTTLE, PLASTIC2024-01-22NoNoCurrent