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 5 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021
Colgate Ultra White CharcoalSODIUM FLUORIDEColgate-Palmolive Company95d06fcc-f56d-43f1-924a-3f91fda59bdf2026-07-22WarningsExact identifier
application number: M021
COLGATE Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POPSODIUM FLUORIDEColgate-Palmolive Companybf465181-01e9-44ca-91f8-03110a6067742026-07-16WarningsExact identifier
application number: M021
Colgate Minions Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Company16634b99-f305-48bf-ac54-a9f53797a9e52026-07-16WarningsExact identifier
application number: M021
Colgate Kids Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Companye8398535-60eb-46fa-8f9f-dff59045a1922026-07-15WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEDabur India Limited56aaa9f5-7eac-11d9-e063-6294a90af3a82026-07-15WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEDabur India Limited56aaba60-523e-6ac7-e063-6394a90a27562026-07-15WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEDabur India Limited56aac050-73e7-298c-e063-6294a90a26eb2026-07-15WarningsExact identifier
application number: M021
Freshen Up twisted peppermintSODIUM FLUORIDEDabur India Limited56aac7a7-c086-2fa5-e063-6294a90aa9592026-07-15WarningsExact identifier
application number: M021
Freshen Up Vanilla MintSODIUM FLUORIDEDabur India Limited56aad223-db88-7cf6-e063-6394a90a6b722026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEMKJ BRANDS LLC2dcd4816-caa5-c006-e063-6394a90ac4872026-07-15WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDEDABUR INDIA LIMITED56acecd2-6966-2ee4-e063-6394a90a356f2026-07-15WarningsExact identifier
application number: M021
Colgate Max Fresh Advanced WhiteningSODIUM FLUORIDEColgate-Palmolive Company01c07c25-2748-4d90-9505-094e2c977c9c2026-07-15WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d51c67b-7409-e5a7-e053-2a91aa0a81fa2026-07-14WarningsExact 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