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 3 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SprinJene Fresh Boost SODIUM FLUORIDE Health and Natural Beauty USA Corp 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 2026-08-14 Warnings Exact identifier application number: M021 SprinJene Natural Sensitivity Relief SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE Health and Natural Beauty USA Corp 32cc5bc2-60c9-4cb4-acde-485ae494aba2 2026-08-14 Warnings Exact identifier application number: M021 SprinJene White Boost SODIUM FLUORIDE Health and Natural Beauty USA Corp 8c401bea-0148-46a0-bbb3-80c17f9e8e3e 2026-08-14 Warnings Exact identifier application number: M021 ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 2b123d70-4f7d-41b0-b48f-711999e97ee0 2026-08-13 Warnings Exact identifier application number: M021 COLGATE STRAWBERRY BURST SODIUM FLUORIDE Colgate-Palmolive Company d037f65c-3d22-4d2a-a0a9-3dcba2357ebd 2026-08-13 Warnings Exact identifier application number: M021 COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company cd954777-697a-4cc7-8f5f-b2caf357ef95 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE KIDS SILLY STRAWBERRY SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. e36ceb7a-9a29-41d8-8d08-a859e515f1f5 2026-08-13 Warnings Exact identifier application number: M021 TOMS OF MAINE WHOLE CARE SPEARMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 08d7ed04-67a4-437a-82c5-496f9893c6c7 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH COOL PEPPERMINT SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 27278b02-c4fd-4092-a632-a14e442f5a95 2026-08-10 Warnings Exact identifier application number: M021 TOMS OF MAINE WICKED FRESH SPEARMINT ICE SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 59a6b9ac-c28b-4ec3-8231-f35054ce0eaf 2026-08-10 Warnings Exact identifier application number: M021 Toms Kids Watermelon Wiggle SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids bubblegum SODIUM FLUORIDE Lander Enterprises, LLC 64b60e74-fceb-4de9-a966-73bf8dbd666c 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids strawberry SODIUM FLUORIDE Lander Enterprises, LLC 7e880d50-8aab-4d57-abc1-e900070f9a11 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush kids watermelon SODIUM FLUORIDE Lander Enterprises, LLC 5cb5eb46-705c-4bb7-bef1-e93a598636fd 2026-08-10 Warnings Exact identifier application number: M021 AutoBrush Mint SODIUM FLUORIDE Lander Enterprises, LLC 0e043431-9d87-478d-87f5-5aa8b0a932eb 2026-08-10 Warnings Exact identifier application number: M021 Willo Minty Mist Dye Free SODIUM FLUORIDE Willo 32, Inc. 3ee5b49e-ca9a-ece6-e063-6394a90a3d00 2026-08-10 Warnings Exact identifier application number: M021 Willo Bubble Twist SODIUM FLUORIDE Willo 32 Inc 36560d62-e901-1f93-e063-6394a90a2803 2026-08-10 Warnings Exact identifier application number: M021 Willo Berry Splash Dye Free SODIUM FLUORIDE Willo 32, Inc 3ea91af9-2895-e530-e063-6394a90a39e5 2026-08-10 Warnings Exact identifier application number: M021 Fluoride Mouth Rinse Anticavity SODIUM FLUORIDE Target Corporation 3daf3cc3-585a-4bb2-9b56-7117d220ed38 2026-08-10 Warnings, Adverse reactions Exact identifier application number: M021 TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 19de1e71-ab94-415f-b66d-e5748dea8317 2026-08-10 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