TheraBreath Complete Oral Rinse

Product NDC
10237-267
11-digit product format
102370267
Labeler code
10237
Product ID
10237-267_4b7fc579-156a-6f86-e063-6394a90ab66a
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
.002 mg/10mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TheraBreath Complete Oral Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.002 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
10237-267-16TheraBreath Complete Oral Rinse473 mL in 1 BOTTLERINSE4732
10237-267-26TheraBreath Complete Oral Rinse2 in 1 PACKAGERINSE22
10237-267-26TheraBreath Complete Oral Rinse473 mL in 1 BOTTLERINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-267THERABREATH COMPLETE ORAL RINSE (ANTICAVITY ORAL RINSE) RINSE [CHURCH & DWIGHT CO., INC.]1Current NDC, 3 package rows20250101_27c33ae1-52c7-baad-e063-6394a90a0611.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-267-1610237026716473 mL in 1 BOTTLE (10237-267-16) 473 ml2024-12-31NoNoCurrent
10237-267-26102370267262 BOTTLE in 1 PACKAGE (10237-267-26) / 473 mL in 1 BOTTLE2 bottle2026-01-01NoNoCurrent