Home NDC 10237-644 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 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.
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 Ingredient Strength SODIUM FLUORIDE 2.4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-644-40 CLOSE UPFreshening with Mouthwash 1 in 1 CARTON GEL, DENTIFRICE 1 11 10237-644-40 CLOSE UPFreshening with Mouthwash 113.4 g in 1 TUBE GEL, DENTIFRICE 113.4 11 10237-644-60 CLOSE UPFreshening with Mouthwash 170 g in 1 TUBE GEL, DENTIFRICE 170 11 10237-644-60 CLOSE UPFreshening with Mouthwash 1 in 1 CARTON GEL, DENTIFRICE 1 11 10237-644-72 CLOSE UPFreshening with Mouthwash 204 g in 1 TUBE GEL, DENTIFRICE 204 11 10237-644-72 CLOSE UPFreshening with Mouthwash 1 in 1 CARTON GEL, DENTIFRICE 1 11 10237-644-80 CLOSE UPFreshening with Mouthwash 1 in 1 CARTON GEL, DENTIFRICE 1 11 10237-644-80 CLOSE UPFreshening with Mouthwash 226.8 g in 1 TUBE GEL, DENTIFRICE 226.8 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 PEG-8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-644 CLOSE UP FRESHENING WITH MOUTHWASH (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 10 Current NDC, Legacy NDC, 8 package rows 20241123_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 48 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H CO., LTD. 13910b55-9b5d-af53-e063-6294a90acf5d 2024-03-13 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude e3bb60f8-2a06-42d6-a182-8c31bb982a2a 2024-03-01 Warnings Exact identifier application number: M021 Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10237-644-40 10237064440 1 TUBE in 1 CARTON (10237-644-40) / 113.4 g in 1 TUBE 1 tube 2001-03-01 0000-00-00 No No Current 10237-644-60 10237064460 1 TUBE in 1 CARTON (10237-644-60) / 170 g in 1 TUBE 1 tube 2001-03-01 0000-00-00 No No Current 10237-644-72 10237064472 1 TUBE in 1 CARTON (10237-644-72) > 204 g in 1 TUBE 1 tube 2001-03-01 0000-00-00 No No Current 10237-644-80 10237064480 1 TUBE in 1 CARTON (10237-644-80) / 226.8 g in 1 TUBE 1 tube 2001-03-01 0000-00-00 No No Current