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 26 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 69271b7a-18c0-4445-8164-cb1620fb5475 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 40bd7406-7ee6-47fe-8481-0a4c8cefce65 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 43194fe1-87a1-4ffa-ad73-a1dcec91fd63 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. b0b3ab27-704a-44b8-8473-d21ac3359ba1 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 39f64f10-f442-45a9-a060-9f99e78c678d 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. ed5a294a-fc03-43dd-825d-23a232060900 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. be558e5b-cf35-4035-a69c-8d66deeac6b2 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. a2591a96-ed66-45b1-abf6-6b26d0bb4f44 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. efe92e48-5086-4b61-a298-0d8ceefe100e 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022
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