FDA.reportPublic FDA data

Tri-Vite Drops with Fluoride

Product NDC
63629-1141
11-digit product format
636291141
Labeler code
63629
Product ID
63629-1141_5ad59217-87ba-4028-8971-f9e377fc679b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-07-25
Substance
ASCORBIC ACID; SODIUM FLUORIDE; VITAMIN A; VITAMIN D
Active strength
35; .5; 1500; 400 mg/mL; mg/mL; [iU]/mL; [iU]/mL
Pharmacologic classes
Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin C [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tri-Vite Drops with Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID35 mg/mL
SODIUM FLUORIDE.5 mg/mL
VITAMIN A1500 [iU]/mL
VITAMIN D400 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPQ6CK8PD0R, 8ZYQ1474W7, 81G40H8B0T, 9VU1KI44GP
Rxcui1365984

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1141-1Tri-Vite Drops with Fluoride50 mL in 1 BOTTLESOLUTION50104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1141-1ML - Milliliter63629-1141f985e363-305a-42c6-9fc0-f96a3cac70d412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1141TRI-VITE DROPS WITH FLUORIDE (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D) SOLUTION [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240515_fe9da1e9-9b36-4702-bec2-13187f0f6548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365984ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSCDfe9da1e9-9b36-4702-bec2-13187f0f6548104
1365984ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral SolutionSYfe9da1e9-9b36-4702-bec2-13187f0f6548104
1365984sodium fluoride 1.1 MG (fluoride ion 0.5 MG) / vitamin A palmitate 1500 UNT / vitamin C 35 MG / vitamin D3 0.01 MG (400 UNT) per ML Oral SolutionSYfe9da1e9-9b36-4702-bec2-13187f0f6548104
1365984vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSYfe9da1e9-9b36-4702-bec2-13187f0f6548104
1365984vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSYfe9da1e9-9b36-4702-bec2-13187f0f6548104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1141-16362911410150 mL in 1 BOTTLE (63629-1141-1) 50 ml2020-10-060000-00-00NoNoCurrent