Home NDC 39892-0603 MediChoice Premium Anticavity Fluoride
Product NDC 39892-0603
11-digit product format 398920603
Labeler code 39892
Product ID 39892-0603_40b23569-3539-20aa-e063-6394a90ae6ea
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler O&M HALYARD, INC.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-03-01
Substance SODIUM FLUORIDE
Active strength 2.43 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 MediChoice Premium Anticavity Fluoride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 2.43 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 891775 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 39892-0603-2 MediChoice Premium Anticavity Fluoride 24 g in 1 TUBE PASTE, DENTIFRICE 24 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 POLYETHYLENE GLYCOL 1500 INACTIVE INGREDIENT 1212Z7S33A MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE INACTIVE INGREDIENT B70850QPHR MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39892-0603 MEDICHOICE PREMIUM ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [OWENS & MINOR] 5 Current NDC, Legacy NDC, 1 package rows 20231213_c6ba9b51-b958-4836-adc8-871529a43fc6.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 37 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE Acuseplanet Inc 3c0e1862-293f-4d23-e063-6294a90a33e1 2025-08-10 Warnings Exact identifier application number: M021 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 Warnings Exact identifier application number: M021 Dentalclean Green Diamond Alcohol Free Mouthwash SODIUM FLUORIDE 0.05% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 5653aa33-4f0e-46b2-9be0-6219143556ec 2025-07-14 Warnings Exact identifier application number: M021 Colgate Total Gum Protect Fresh Mint STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 570e3bd6-eede-4270-9d78-055aeb2b8c17 2025-07-14 Warnings Exact identifier application number: M021 OraPro Fluoride Anticavity FLUORIDE TOOTHPASTE Protegera, Inc. 93b0181c-e29f-42f4-80f5-366463b68f09 2025-07-10 Warnings Exact identifier application number: M021 Enamur Fluoride AntiCavity Toothpast FLUORIDE TOOTHPAST Protegera, Inc 557ced45-f54e-43d8-aa13-46f75b79367c 2025-07-10 Warnings Exact identifier application number: M021 Super Strawberry STRAWBERRY TOOTHPASTE SuperMouth, LLC. a8c2b68d-d28b-41c0-a383-cc706b25aa1a 2025-07-05 Warnings Exact identifier application number: M021 Super Mint SUPER MINT TOOTHPASTE SuperMouth, LLC. be0915f3-36c4-4200-9d15-704cfbd632b4 2025-07-05 Warnings Exact identifier application number: M021 Super Vanilla VANILLA TOOTHPASTE SuperMouth, LLC. 3ddfe20a-86f1-4566-bb77-82c9749411f6 2025-07-05 Warnings Exact identifier application number: M021 Super Chocolate CHOCOLATE TOOTHPASTE SuperMouth, LLC. 48607622-7c5e-4ddc-8d83-707f26c0553f 2025-07-05 Warnings Exact identifier application number: M021 Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. 13dba3ce-88a8-490c-a906-cfd206d1d290 2025-07-01 Warnings Exact identifier application number: M021 evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. baae4f4a-54ef-472a-9c94-31703435750b 2025-07-01 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 39892-0603-2 39892060302 24 g in 1 TUBE (39892-0603-2) 24 g 2013-03-01 0000-00-00 No No Current