Home NDC 0126-0022 PreviDent 5000 Enamel Protect
Product NDC 0126-0022
11-digit product format 001260022
Labeler code 0126
Product ID 0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM FLUORIDE and POTASSIUM NITRATE
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Colgate Oral Pharmaceuticals, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-03-30
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 57.5; 5.8 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PreviDent 5000 Enamel Protect
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 57.5 mg/mL POTASSIUM NITRATE 5.8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII 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 0126-0022-92 PreviDent 5000 Enamel Protect 100 mL in 1 BOTTLE GEL, DENTIFRICE 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0126-0022 PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20220820_bbc66b1b-e05c-4e14-bef3-b8bae419fc89.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0126-0022-12 00126002212 3.5 mL in 1 PACKET (0126-0022-12) 3.5 ml 2011-03-30 0000-00-00 No No Current 0126-0022-92 00126002292 100 mL in 1 BOTTLE (0126-0022-92) 100 ml 2011-03-30 0000-00-00 No No Current