FDA.reportPublic FDA data

Complete Care Whole Mouth Protection

Product NDC
10237-675
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10237-67510237-675-12DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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 18 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDELidl US, LLCc47475aa-3125-410f-aa31-0add6e4ce1252026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf4c02924-95ee-09d2-e053-2995a90a81212026-02-03Exact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5d97011-7be3-3b1c-e053-2a95a90ade862026-02-03Exact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc.c28c3475-efbb-4099-83ab-ab91bac9dfc32026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEDemoulas Super Markets, Inc65abfb4d-3a1e-42df-b343-f270ce60a3bf2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company102e4d9c-0fae-d48a-e063-6294a90aac942026-02-03WarningsExact identifier
application number: M021
Crest Plus Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08767b0f-ed6e-8d32-e063-6294a90a10cd2026-02-03WarningsExact identifier
application number: M021
Crest Braces Care Anticavity Fluoride RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd8398cfd-9af6-690d-e053-2995a90a9b7c2026-02-03WarningsExact identifier
application number: M021
AutoBrush bubblegumSODIUM FLUORIDELander Enterprises, LLC2e85d6f7-2df8-4eb9-bc97-d7b7af7fb4602026-02-03WarningsExact identifier
application number: M021
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLCd859d02d-a036-4d90-bed4-9a5c31e9e1ef2026-02-03WarningsExact identifier
application number: M021
Glowing WhiteSODIUM FLUORIDEDemoulas Super Markets, Inc32faf47d-b64f-4454-9f14-51503504c6b52026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Sodium fluorideSODIUM FLUORIDEDemoulas Super Markets, Inc2f5d3c75-1a11-47e1-b297-e2302177efe72026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEDemoulas Super Markets, Inc096e6a1d-316b-432a-bf27-70e8a13337cc2026-02-03Warnings, Adverse reactionsExact identifier
application number: M021
Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d1932f-a85c-7b8f-e063-6394a90a6aca2026-02-02WarningsExact identifier
application number: M021
Listerine Total Care Mild Alcohol Free Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC49d4f96f-e61f-e6e6-e063-6294a90ab0a02026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Toy Story Wild West WatermelonSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d69901-0b07-b07d-e063-6394a90a3c342026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Frozen Blizzard BerrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6c1c9-cd21-cac6-e063-6294a90a81d62026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Princesses Grand GrapeSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d6f926-da4e-26df-e063-6294a90a1c0c2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker PunchSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d70b88-d57c-37cd-e063-6294a90a4a592026-02-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERite Aid Corporation54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe2026-02-02Warnings, Adverse reactionsExact 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 startMarketing endSampleExclude flagStatus
10237-675-09102370675091 TUBE in 1 CARTON (10237-675-09) / 25.5 g in 1 TUBE1 tube2021-12-310000-00-00NoNoCurrent
10237-675-12102370675121 TUBE in 1 CARTON (10237-675-12) > 340 g in 1 TUBE1 tube2021-12-310000-00-00NoNoCurrent
10237-675-60102370675601 TUBE in 1 CARTON (10237-675-60) / 170 g in 1 TUBE1 tube2021-12-310000-00-00NoNoCurrent
10237-675-62102370675622 TUBE in 1 CARTON (10237-675-62) / 170 g in 1 TUBE2 tube2023-08-24NoNoCurrent
10237-675-64102370675644 CARTON in 1 PACKAGE (10237-675-64) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE4 carton2022-03-04NoNoCurrent