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 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companycef9a30c-a18c-47e9-b276-f56608f0400f2024-10-01WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company86c4b51e-b086-4566-8f94-a951bf0c62542024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening Fresh BoostSTANNOUS FLUORIDEColgate-Palmolive Companyc436382e-2755-c882-2970-4be1b9ca537b2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Whitening GelSTANNOUS FLUORIDEColgate-Palmolive Company27c4eed5-9121-4e09-9d42-e0a3e84301092024-09-30WarningsExact identifier
application number: M021
Colgate Total Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company56434e3d-ba0a-8b42-6c97-0d00556067932024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Mint Stripe GelSTANNOUS FLUORIDEColgate-Palmolive Companyabfbcacd-9c1a-4472-9e91-a85e78050a9e2024-09-30WarningsExact identifier
application number: M021
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef2024-09-27WarningsExact identifier
application number: M021
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios Inc.b197ac2d-f9d6-4937-a0a6-2f425e4c37962024-09-26WarningsExact identifier
application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVORSODIUM FLUORIDEAshtel Studios, Incdc04ee5c-3561-4579-8f9b-00266a8c88712024-09-25WarningsExact identifier
application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)SODIUM FLUORIDEMADE BY DENTISTS INC94939abe-b05e-4ea2-a1a6-204da857b4aa2024-09-18WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Arctic BlastSODIUM FLUORIDEChattem, Inc.2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c572024-08-22WarningsExact identifier
application number: M021
CinnaFreshSODIUM FLUORIDEBob Barker Company Inc.3fbd95f0-a10c-4351-ad80-7e90b2d6a6f52024-08-22WarningsExact identifier
application number: M021
Karl and Hans Botanic Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATIONd1233fc3-047c-4e26-bb2b-8ebde09c05a92024-08-08WarningsExact identifier
application number: M021
Karl and Hans Botanic JasmineSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION6c0335e6-f041-48c7-9da3-88c124b84b002024-08-08WarningsExact identifier
application number: M021
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact identifier
application number: M021
Just For KidsSTANNOUS FLUORIDESolventum US LLC0f1afc36-f699-4072-b90b-c9f5be989a492024-08-01WarningsExact identifier
application number: M021
Clinpro Tooth CremeSODIUM FLUORIDESolventum US LLC786c6184-6bc8-4376-9ce2-3e35af1932102024-08-01WarningsExact identifier
application number: M021
PerioMedSTANNOUS FLUORIDESolventum US LLC7f79eb00-86df-4284-b415-47f45e4849da2024-08-01WarningsExact 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