FDA.reportPublic FDA data

PEROXICARE

Product NDC
10237-655
11-digit product format
102370655
Labeler code
10237
Product ID
10237-655_45b5a6b7-132b-ad91-e063-6394a90a9f06
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-29
Substance
SODIUM FLUORIDE
Active strength
2.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PEROXICARE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g

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
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
10237-655-12PEROXICARE170 g in 1 TUBEPASTE, DENTIFRICE1707
10237-655-12PEROXICARE2 in 1 CARTONPASTE, DENTIFRICE27
10237-655-46PEROXICARE4 in 1 PACKAGEPASTE, DENTIFRICE47
10237-655-46PEROXICARE1 in 1 CARTONPASTE, DENTIFRICE17
10237-655-60PEROXICARE170 g in 1 TUBEPASTE, DENTIFRICE1707
10237-655-60PEROXICARE1 in 1 CARTONPASTE, DENTIFRICE17
10237-655-72PEROXICARE204 g in 1 TUBEPASTE, DENTIFRICE2047
10237-655-72PEROXICARE1 in 1 CARTONPASTE, DENTIFRICE17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS99618PEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-655PEROXIE CARE TARTAR CONTROL HEALTHY GUMS BAKING SODA AND PEROXIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]6Current NDC, Legacy NDC, 8 package rows20241123_55262538-15ce-455c-93b1-bb02b5f81d6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN55262538-15ce-455c-93b1-bb02b5f81d6b7
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD55262538-15ce-455c-93b1-bb02b5f81d6b7
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY55262538-15ce-455c-93b1-bb02b5f81d6b7
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY55262538-15ce-455c-93b1-bb02b5f81d6b7
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY55262538-15ce-455c-93b1-bb02b5f81d6b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-655-09102370655091 TUBE in 1 CARTON (10237-655-09) / 25 g in 1 TUBE1 tube2026-06-070Current
10237-655-12102370655122 TUBE in 1 CARTON (10237-655-12) / 170 g in 1 TUBE2 tube2012-01-290000-00-00NoNoCurrent
10237-655-46102370655464 CARTON in 1 PACKAGE (10237-655-46) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE4 carton2025-01-01NoNoCurrent
10237-655-60102370655601 TUBE in 1 CARTON (10237-655-60) / 170 g in 1 TUBE1 tube2012-01-290000-00-00NoNoCurrent
10237-655-7210237065572204 g in 1 TUBE204 gHistorical