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
VITAMIN A35 mg/mL
ASCORBIC ACID.5 mg/mL
VITAMIN D1500 [iU]/mL
SODIUM FLUORIDE400 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81G40H8B0TInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
9VU1KI44GPInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1365984Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe9da1e9-9b36-4702-bec2-13187f0f6548Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepackfe9da1e9-9b36-4702-bec2-13187f0f65482026-03-18Warnings, Adverse reactionsExact identifier
ndc (product): 63629-1141

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