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 46 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor SODIUM FLUORIDE Ashtel Studios Inc. bbf6cfe7-c5e5-4e63-ac7d-4535a0ca3973 2024-07-31 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 32780fe9-82bf-42f8-8218-bed5bc579c72 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 7ba8cff2-92a4-4432-aaf3-50358d9483a2 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ed057c95-90cd-4edb-ac00-78db8f6a065b 2024-07-29 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. f01c5eaf-7e81-4b30-bb6f-50566a727364 2024-07-29 Warnings Exact identifier application number: M021 Sodium Monofluorophosphate WHITE TOOTHPASTE Dynarex Corporation 1be422b9-6320-ed5c-e063-6294a90a7e42 2024-07-03 Warnings Exact identifier application number: M021 Wpgcng Antiacvity Fluoride Mouthwash SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 5756206e-43cc-8cc7-e063-6394a90a2950 2024-07-03 Warnings Exact identifier application number: M021 dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum SODIUM FLUORIDE Lidl US, LLC 0c77ba33-acb9-4c83-aa75-7d5c82f903eb 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE WHITENING MINT SODIUM FLUORIDE Lidl US, LLC 37011052-16ef-4ae4-aade-a86f9fa9cdac 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Lidl US, LLC ccf54743-81c2-43f8-9c5c-d4baa85fc18d 2024-07-02 Warnings Exact identifier application number: M021 SmileSense STANNOUS FLUORIDE SGII, INC 1c371393-da75-c9c8-e063-6294a90a5840 2024-07-01 Warnings Exact identifier application number: M021 Sodium Fluoride CLEAR MINT, GEL TOOTHPASTE Dynarex Corporation 1be193b6-4c07-4f0a-e063-6394a90a32c7 2024-06-27 Warnings Exact identifier application number: M021 CREST CAVITY PROTECTION COOL MINT SODIUM FLUORIDE A-S Medication Solutions dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d 2024-06-12 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. a37e9d9c-dca9-4d58-a716-4514ebe8ec88 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 0e6b01a4-1132-489f-936c-d3a54e9e21e0 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ffb8c43c-8f45-42ec-83eb-f0c83f7f99f8 2024-06-11 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 1a26ad70-9773-dc4f-e063-6294a90ac333 2024-05-31 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE LG H&H Co.,Ltd. 1a01481f-3e02-634e-e063-6394a90ac5fc 2024-05-31 Warnings Exact identifier application number: M021 Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios Inc. 86dd5e9c-71c3-46ce-ae4c-45d19468667d 2024-05-29 Warnings Exact identifier application number: M021 Dentalclean Doctor Duck Kids Flouride Mouthwash SODIUM FLUORIDE 0.02% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 18806738-82fa-1a37-e063-6294a90a3888 2024-05-15 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