FDA.reportPublic FDA data

Made by Dentists Enamel Rebuilding Professional

Product NDC
62776-003
11-digit product format
627760003
Labeler code
62776
Product ID
62776-003_383e8249-c326-68b6-e063-6294a90a17cd
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
Fulijaya Manufacturing Sdn. Bhd
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Made by Dentists Enamel Rebuilding Professional
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62776-003-01Made by Dentists Enamel Rebuilding Professional120 g in 1 TUBEPASTE1202
62776-003-01Made by Dentists Enamel Rebuilding Professional1 in 1 CARTONPASTE12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN178d7538-c178-b8ca-e063-6394a90a7d332
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD178d7538-c178-b8ca-e063-6394a90a7d332
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY178d7538-c178-b8ca-e063-6394a90a7d332
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY178d7538-c178-b8ca-e063-6394a90a7d332
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY178d7538-c178-b8ca-e063-6394a90a7d332
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY178d7538-c178-b8ca-e063-6394a90a7d332
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY178d7538-c178-b8ca-e063-6394a90a7d332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62776-003-01627760003011 TUBE in 1 CARTON (62776-003-01) / 120 g in 1 TUBE1 tube2024-01-01NoNoCurrent