FDA.reportPublic FDA data

PEROXICARE

Product NDC
10237-655
Requested package NDC
10237-655-60
11-digit product format
102370655
Labeler code
10237
Product ID
10237-655_53d6b975-5f6c-c431-e063-6294a90a445c
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
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
PEROXICARE
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55262538-15ce-455c-93b1-bb02b5f81d6bAvailable 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
10237-655-12PEROXICARE170 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

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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021

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
10237-655-60102370655601 TUBE in 1 CARTON (10237-655-60) / 170 g in 1 TUBE1 tube2012-01-290000-00-00NoNoCurrent