Home NDC 42199-006 Pearl White
Product NDC 42199-006
11-digit product format 421990006
Labeler code 42199
Product ID 42199-006_0b3e6b1d-3644-3f2c-e063-6394a90a25a1
Type HUMAN OTC DRUG
Nonproprietary name Potassium nitrate, Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Beyond International Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-06-12
Marketing end 2026-11-27
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1 mg/g; mg/g
NDC exclude flag No
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 Pearl White Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 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 42199-006-05 Pearl White 1 in 1 CARTON PASTE, DENTIFRICE 1 2 42199-006-05 Pearl White 120 g in 1 TUBE PASTE, DENTIFRICE 120 2 42199-006-06 Pearl White 1 in 1 CARTON PASTE, DENTIFRICE 1 2 42199-006-06 Pearl White 40 g in 1 TUBE PASTE, DENTIFRICE 40 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42199-006 PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND INTERNATIONAL INC.] 2 Current NDC, Legacy NDC, 4 package rows 20231129_51c79544-9536-5863-e054-00144ff8d46c.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 29 of 40 · 786 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 42199-006-05 42199000605 1 TUBE in 1 CARTON (42199-006-05) / 120 g in 1 TUBE 1 tube 2017-06-12 2026-11-27 No No Current 42199-006-06 42199000606 1 TUBE in 1 CARTON (42199-006-06) / 40 g in 1 TUBE 1 tube 2017-06-12 2026-11-27 No No Current