Pearl White

Product NDC
42199-005
11-digit product format
421990005
Labeler code
42199
Product ID
42199-005_4b897d6f-13a1-487f-9aa1-1ee48fd787ab
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
BEYOND TECHNOLOGY CORP.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-10-05
Marketing end
0000-00-00
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
0 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42199-005DDiscontinued by firm2026-08-17
excluded packagepackage42199-00542199-005-05DDiscontinued by firm2026-08-17
excluded packagepackage42199-00542199-005-06DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42199-005-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42199-005-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42199-005-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42199-005-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42199-005-05DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42199-005-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42199-005-05DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42199-005-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42199-005-05DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42199-005-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42199-005-05DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42199-005-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42199-005-05DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42199-005-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42199-005-05DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42199-005-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42199-005-05DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42199-005-06DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42199-005-05DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42199-005-06DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42199-005-05DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42199-005-06DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42199-005-05DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42199-005-06DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42199-005-06IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42199-005-05IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42199-005-06IInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42199-005-05IInactivated by FDA110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
NITRATE IONACTIVE MOIETYT93E9Y2844PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO91PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWNPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)INACTIVE INGREDIENTX70SE62ZARPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SODIUM PERBORATEINACTIVE INGREDIENTY52BK1W96CPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
SORBITOLINACTIVE INGREDIENT506T60A25RPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1
WATERINACTIVE INGREDIENT059QF0KO0RPEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND TECHNOLOGY CORP. ]1