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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Space Jam Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company54cbfb09-8fd7-ef08-99fd-14fc019c81ff2024-11-14WarningsExact identifier
application number: M021
Colgate Kids Llama Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolivea7b02cb2-cfb3-7b35-42da-7924d156dcc32024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Clean MintSODIUM FLUORIDEColgate-Palmolive Company82bc1101-84d7-4e21-be9c-870ad88a4b7c2024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDECOLGATE PALMOLIVE COMPANYb6ca4ec7-5087-4693-82b7-199b44d7f9312024-11-13WarningsExact identifier
application number: M021
Listerine Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
application number: M021
Listerine Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLCee9a962d-83c7-4b13-bff6-140e48785e8a2024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint ShieldSODIUM FLUORIDEKenvue Brands LLCd69d2e0d-a3e3-4d95-992d-c0c59172b3a52024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDELG H&H Co.,Ltd.2697fa68-b991-ab09-e063-6394a90aec4c2024-11-01WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.2698d6d8-051b-6c10-e063-6394a90a94182024-11-01WarningsExact identifier
application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)SODIUM FLUORIDEMADE BY DENTISTS INC263c448b-728f-4370-bcdb-148d614d9b342024-10-30WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.17f589e9-f4ba-46d3-a345-db38f9a9067d2024-10-17WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
application number: M021
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
application number: M021
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDENavajo Manufacturing Company Inc.23851360-e30e-dd97-e063-6394a90a54742024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact 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