Home NDC 75065-033 Made by Dentists Enamel 10 Fluoride Anticavity
Product NDC 75065-033
11-digit product format 750650033
Labeler code 75065
Product ID 75065-033_5b9b278a-8dab-1f6b-e063-6394a90a788b
Type HUMAN OTC DRUG
Nonproprietary name POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form PASTE
Route DENTAL
Labeler Made By Dentists Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-01
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.5 mg/g; mg/g
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 Made by Dentists Enamel 10 Fluoride Anticavity
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.5 mg/g
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 19 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povi-One POVIDONE-IODINE 10% TOPICAL Elevate Oral Care f5252b4f-5e14-509e-e053-2995a90a6db8 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf25-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf28-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f19a1a7-c234-8d26-e063-6394a90ad7e9 2025-09-18 Warnings Exact identifier application number: M022 McKesson Orasol Gel BENZOCAINE 20% McKesson Medical-Surgical cc8724f4-c482-5e7d-e053-2a95a90a608f 2025-09-09 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Medical Group Care LLC 3d70bca7-e830-e693-e063-6294a90a73f9 2025-08-28 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Army & Air Force Exchange Service 3d70450f-04ea-1885-e063-6294a90a05bd 2025-08-28 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa2bad-5b8b-8aac-e063-6394a90a9f49 2025-08-27 Warnings Exact identifier application number: M022 R Cos CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa767a-1344-5ed9-e063-6394a90a5fe6 2025-08-27 Warnings Exact identifier application number: M022 Na Mi Cal CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cfbcd1-eb13-933c-e063-6294a90a7e59 2025-08-27 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cf8f80-c638-4d94-e063-6294a90a5400 2025-08-27 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE SODIUM MONOFLUOROPHOSPHATE Yangzhou Hongshengding Chemical Co.,Ltd. 63a69664-8611-4d69-b871-8d1d5b553e5c 2025-08-18 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE SODIUM CHLORIDE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) f51491d8-12ad-4b1b-a171-c621bfdcc341 2025-08-12 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. b9227966-847c-40c3-87f2-8bea3954ec84 2025-08-12 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 5f4b1960-43ac-4c74-9410-210c48bd8a1b 2025-08-12 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 113cdb83-0fdd-40f2-8ee6-b771dca99713 2025-08-12 Warnings Exact identifier application number: M022 CVS Pharmacy Maximum Strength BENZOCAINE CVS Pharmacy 13bf31c1-78e3-459f-9249-b0b6e2c17a13 2025-08-12 Warnings Exact identifier application number: M022 Rexall Maximum Strength BENZOCAINE Rexall 8f6e2780-cfb7-4bef-9b7d-13cb80d8923e 2025-08-12 Warnings Exact identifier application number: M022 Walgreens Maximum Strength BENZOCAINE Walgreens 8f24309d-d393-455a-a9a5-a55344adf36b 2025-08-12 Warnings Exact identifier application number: M022 Oral Anesthetic Liquid BENZOCAINE Meijer, Inc. 0321c480-e150-421d-e063-6294a90ad687 2025-08-12 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75065-033-06 75065003306 1 TUBE in 1 CARTON (75065-033-06) / 120 g in 1 TUBE 1 tube 2026-08-01 No No Current 75065-033-07 75065003307 1 TUBE in 1 CARTON (75065-033-07) / 20 g in 1 TUBE 1 tube 2026-09-01 Yes No Current