ORAL PROJEQT O1 TOOTHPASTETABLETS

Product NDC
76058-500
11-digit product format
760580500
Labeler code
76058
Product ID
76058-500_e6de7e90-4789-18dc-e053-2995a90a63d5
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
TABLET
Route
ORAL
Labeler
Sungwon Pharmaceutical Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-08-01
Marketing end
0000-00-00
Substance
PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SODIUM FLUORIDE; SODIUM PYROPHOSPHATE
Active strength
0 g/1; g/1; g/1; g/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76058-500-01ORAL PROJEQT O1 TOOTHPASTETABLETS62 in 1 BOTTLE, GLASSTABLET621

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76058-500ORAL PROJEQT O1 TOOTHPASTETABLETS (SODIUM FLUORIDE) TABLET [SUNGWON PHARMACEUTICAL CO., LTD.]1Legacy NDC, 1 package rows20220824_e6de7e8a-08c8-962f-e053-2995a90aee46.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76058-500-017605805000162 TABLET in 1 BOTTLE, GLASS (76058-500-01) 62 tablet2022-08-010000-00-00NoNoCurrent