CLOSE UP

Product NDC
10237-644
11-digit product format
102370644
Labeler code
10237
Product ID
10237-644_3e62cc44-3168-5e02-e063-6294a90a129d
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-03-01
Substance
SODIUM FLUORIDE
Active strength
2.4 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 packagepackage10237-64410237-644-72DDiscontinued by firm2026-10-05

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 · 20 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0510237-644-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2610237-644-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2610237-644-72f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3110237-644-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3110237-644-722ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2810237-644-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2810237-644-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2110237-644-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2110237-644-72cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1010237-644-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1010237-644-72cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3110237-644-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3110237-644-72302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2010237-644-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2010237-644-72ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1010237-644-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1010237-644-720efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0810237-644-72ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0310237-644-72367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0910237-644-72557ba5c1ecfa…9c80585c8c6e…

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
CLOSE UP
Brand name suffix
Freshening with Mouthwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 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
e660b0d7-4cc5-4028-bdf5-016b85899728Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-644-40CLOSE UPFreshening with Mouthwash1 in 1 CARTONGEL, DENTIFRICE111
10237-644-40CLOSE UPFreshening with Mouthwash113.4 g in 1 TUBEGEL, DENTIFRICE113.411
10237-644-60CLOSE UPFreshening with Mouthwash170 g in 1 TUBEGEL, DENTIFRICE17011
10237-644-60CLOSE UPFreshening with Mouthwash1 in 1 CARTONGEL, DENTIFRICE111
10237-644-72CLOSE UPFreshening with Mouthwash204 g in 1 TUBEGEL, DENTIFRICE20411
10237-644-72CLOSE UPFreshening with Mouthwash1 in 1 CARTONGEL, DENTIFRICE111
10237-644-80CLOSE UPFreshening with Mouthwash1 in 1 CARTONGEL, DENTIFRICE111
10237-644-80CLOSE UPFreshening with Mouthwash226.8 g in 1 TUBEGEL, DENTIFRICE226.811

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ECLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-644CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]10Current NDC, Legacy NDC, 8 package rows20241123_e660b0d7-4cc5-4028-bdf5-016b85899728.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 25 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNe660b0d7-4cc5-4028-bdf5-016b8589972811
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDe660b0d7-4cc5-4028-bdf5-016b8589972811
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYe660b0d7-4cc5-4028-bdf5-016b8589972811
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe660b0d7-4cc5-4028-bdf5-016b8589972811
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe660b0d7-4cc5-4028-bdf5-016b8589972811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-644-40102370644401 TUBE in 1 CARTON (10237-644-40) / 113.4 g in 1 TUBE1 tube2001-03-010000-00-00NoNoCurrent
10237-644-60102370644601 TUBE in 1 CARTON (10237-644-60) / 170 g in 1 TUBE1 tube2001-03-010000-00-00NoNoCurrent
10237-644-72102370644721 TUBE in 1 CARTON (10237-644-72) > 204 g in 1 TUBE1 tube2001-03-010000-00-00NoNoCurrent
10237-644-80102370644801 TUBE in 1 CARTON (10237-644-80) / 226.8 g in 1 TUBE1 tube2001-03-010000-00-00NoNoCurrent