FDA.reportPublic FDA data

Enamel Defense

Product NDC
10237-666
11-digit product format
102370666
Labeler code
10237
Product ID
10237-666_2763d4eb-e0e9-c03a-e063-6394a90af967
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
2020-04-01
Substance
SODIUM FLUORIDE
Active strength
.24 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Enamel Defense
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 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
9e8f1ce9-b161-50db-e053-2995a90ad32bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
10237-666-09Enamel Defense1 in 1 CARTONPASTE, DENTIFRICE13
10237-666-09Enamel Defense25 g in 1 TUBEPASTE, DENTIFRICE253
10237-666-43Enamel Defense121 g in 1 TUBEPASTE, DENTIFRICE1213
10237-666-43Enamel Defense1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-666ENAMEL DEFENSE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20241123_9e8f1ce9-b161-50db-e053-2995a90ad32b.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 17 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN9e8f1ce9-b161-50db-e053-2995a90ad32b3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD9e8f1ce9-b161-50db-e053-2995a90ad32b3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY9e8f1ce9-b161-50db-e053-2995a90ad32b3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY9e8f1ce9-b161-50db-e053-2995a90ad32b3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY9e8f1ce9-b161-50db-e053-2995a90ad32b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-666-09102370666091 TUBE in 1 CARTON (10237-666-09) / 25 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent
10237-666-43102370666431 TUBE in 1 CARTON (10237-666-43) / 121 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent