Home NDC 66975-720 PRO-SYS
Product NDC 66975-720
11-digit product format 669750720
Labeler code 66975
Product ID 66975-720_4e53a23c-7977-632d-e063-6394a90a7ae6
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL; ORAL
Labeler Benco Dental
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance SODIUM FLUORIDE
Active strength .11 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 PRO-SYS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .11 g/100g
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 66975-720-01 PRO-SYS 113.4 g in 1 TUBE PASTE, DENTIFRICE 113.4 1 66975-720-02 PRO-SYS 24 g in 1 TUBE PASTE, DENTIFRICE 24 1
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 36 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MediChoice Fluoride SODIUM MONOFLUOROPHOSPHATE O&M HALYARD, INC. a87956fa-8975-4a44-9e9a-4b2191e401fe 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b6f893d-74ac-421e-a78b-f495ac425af0 2025-10-09 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. a3e989f8-e6a2-4e13-8faa-77e95895166d 2025-10-09 Warnings Exact identifier application number: M021 TARGET UP AND UP ANTICAVITY SODIUM FLUORIDE 0.05% TARGET CORPORATION 2992efce-1c66-df40-e063-6294a90ab3c0 2025-10-08 Warnings Exact identifier application number: M021 MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE O&M HALYARD, INC. c6ba9b51-b958-4836-adc8-871529a43fc6 2025-10-08 Warnings Exact identifier application number: M021 Tidalove SPICY CINNAMON TOOTHPASTE TABLETS Paranmare LLC 4092fcbf-27f7-b067-e063-6394a90a41c6 2025-10-07 Warnings Exact identifier application number: M021 Tidalove COOL MINT TOOTHPASTE TABLETS Paranmare LLC 4093060c-23a5-c77a-e063-6394a90a9304 2025-10-07 Warnings Exact identifier application number: M021 Tidalove YUZU MINT TOOTHPASTE TABLETS Paranmare LLC 40946943-21cf-b114-e063-6394a90aed3f 2025-10-07 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC fdb16e59-5be1-4bd0-a940-d542d67fb2df 2025-10-02 Warnings Exact identifier application number: M021 Intensive Enamel Repair Whitening TP INTENSIVE ENAMEL REPAIR WHITENING TP Topco Associates LLC 3012a8da-7595-2f7c-e063-6294a90ae120 2025-09-30 Warnings Exact identifier application number: M021 Made by Dentists For Kids Eyeball Juice (Watermelon) SODIUM FLUORIDE MADE BY DENTISTS INC b2ad2b19-6fdf-454d-9b1d-49b1c81016fd 2025-09-30 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. a38363e6-7105-4663-95a0-09ecb2948f83 2025-09-30 Warnings Exact identifier application number: M021 UNPA CHA CHA TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fae966e-0246-b9f2-e063-6394a90a494c 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Tooth SODIUM MONOFLUOROPHOSPHATE DONG IL PHARMS CO.,LTD 3fb01bea-7205-49ba-e063-6294a90a3841 2025-09-26 Warnings Exact identifier application number: M021 Cloveden Sensitive Care Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 3fb153f1-ba6e-7251-e063-6294a90abe62 2025-09-26 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE DONG IL PHARMS CO.,LTD 3fb1a2ee-381e-a9e8-e063-6394a90a864b 2025-09-26 Warnings Exact identifier application number: M021 unpa Cha Cha Toothpaste SODIUM MONOFLUOROPHOSPHATE Lycl Inc. 230b3cf2-053a-4e8b-8d50-05bbc877faa8 2025-09-25 Warnings Exact identifier application number: M021 TheraBreath Anticavity SODIUM FLUORIDE Church & Dwight Co., Inc. 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da 2025-09-19 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1 2025-09-18 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC c1bbdd36-53fb-43a3-ba20-afbeb6359d31 2025-09-18 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 Sample Exclude flag Status 66975-720-01 66975072001 113.4 g in 1 TUBE (66975-720-01) 113.4 g 2025-12-01 No No Current 66975-720-02 66975072002 24 g in 1 TUBE (66975-720-02) 24 g 2025-12-01 No No Current