TheraBreath

Product NDC
10237-268
11-digit product format
102370268
Labeler code
10237
Product ID
10237-268_4618e390-903a-a1d0-e063-6294a90ab294
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
KIT
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TheraBreath
Brand name suffix
AM-PM Twin Pack
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui240698

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-268-01TheraBreathAM-PM Twin Pack1 in 1 CARTONKIT11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
10237-268-01102370268011 KIT in 1 CARTON (10237-268-01) * 473 mL in 1 BOTTLE, PLASTIC * 473 mL in 1 BOTTLE, PLASTIC1 kit2025-02-03NoNoCurrent