FDA.reportPublic FDA data

Complete Care Whole Mouth Protection

Product NDC
10237-675
Requested package NDC
10237-675-62
11-digit product format
102370675
Labeler code
10237
Product ID
10237-675_3e6329fb-e4f4-d077-e063-6394a90a7530
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
2021-12-31
Substance
SODIUM FLUORIDE
Active strength
1.5 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
Complete Care Whole Mouth Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 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
d00f9d16-de0e-4ffc-e053-2a95a90a2069Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-675-09Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-09Complete Care Whole Mouth Protection25.5 g in 1 TUBEPASTE, DENTIFRICE25.54
10237-675-12Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-12Complete Care Whole Mouth Protection340 g in 1 TUBEPASTE, DENTIFRICE3404
10237-675-60Complete Care Whole Mouth Protection170 g in 1 TUBEPASTE, DENTIFRICE1704
10237-675-60Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14
10237-675-62Complete Care Whole Mouth Protection170 g in 1 TUBEPASTE, DENTIFRICE1704
10237-675-62Complete Care Whole Mouth Protection2 in 1 CARTONPASTE, DENTIFRICE24
10237-675-64Complete Care Whole Mouth Protection4 in 1 PACKAGEPASTE, DENTIFRICE44
10237-675-64Complete Care Whole Mouth Protection1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-675COMPLETE CARE WHOLE MOUTH PROTECTION (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 10 package rows20241123_d00f9d16-de0e-4ffc-e053-2a95a90a2069.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 36 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
application number: M021
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
application number: M021
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
application number: M021
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
application number: M021
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
application number: M021
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
application number: M021
ndc (package): 10237-675-62
ndc (product): 10237-675
ndc11 (package): 10237067562
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8264e849-a6b3-4953-a85b-da9d4e7f5a702025-09-02WarningsExact identifier
application number: M021
CAREKON ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEHunan Yinhuatang Pharmaceutical Technology Co., Ltd.3baca3b6-ff48-0579-e063-6394a90abd082025-08-29WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEAcuseplanet Inc3c0e1862-293f-4d23-e063-6294a90a33e12025-08-10WarningsExact identifier
application number: M021
Ipana Wintergreen FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Inc.5776cc3e-4fd1-4bd7-8d82-f82508e6b8d02025-07-28WarningsExact identifier
application number: M021
Ipana Bucky Beaver Bubble Gum Childrens FluorideSODIUM MONOFLUOROPHOSPHATEMaxill Ince7aa2a8d-7140-4718-bf69-917bb50d32c72025-07-28WarningsExact identifier
application number: M021
Dubai Chocolate FlavorANTICAVITY TOOTHPASTESuperMouth, LLC.d1615a53-ecfc-49d1-b836-f7643b9d26602025-07-24WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.0c7ede82-3b28-40ae-8dfd-cec58825f9382025-07-23WarningsExact identifier
application number: M021
Dubai Chocolate Fluoride MouthwashANTICAVITY MOUTHWASHSuperMouth, LLC.ef81a983-64c1-4913-9235-25451f0238522025-07-23WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.3409a749-4a1a-4950-8c21-364d1b977af72025-07-22WarningsExact identifier
application number: M021
Act Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.dc209500-2bf4-42fb-b3a1-d0fb8d63dbd82025-07-22WarningsExact identifier
application number: M021
Brush Buddies Oral Rinse Sparkle MintSODIUM FLUORIDEASHTEL STUDIOS, INCfe2c06fc-6497-4888-877f-1a88e02fad202025-07-15WarningsExact identifier
application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.1620c7fa-2af6-4462-af5d-9e122942788a2025-07-15WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNd00f9d16-de0e-4ffc-e053-2a95a90a20694
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDd00f9d16-de0e-4ffc-e053-2a95a90a20694
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYd00f9d16-de0e-4ffc-e053-2a95a90a20694
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYd00f9d16-de0e-4ffc-e053-2a95a90a20694
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYd00f9d16-de0e-4ffc-e053-2a95a90a20694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-675-62102370675622 TUBE in 1 CARTON (10237-675-62) / 170 g in 1 TUBE2 tube2023-08-24NoNoCurrent