FDA.reportPublic FDA data

Tri-Vite Drops with Fluoride

Product NDC
72162-1659
11-digit product format
721621659
Labeler code
72162
Product ID
72162-1659_7a78e021-d49e-4d7c-bc21-c1e657017d77
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
72162-1659-2Tri-Vite Drops with Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION502
72162-1659-2Tri-Vite Drops with Fluoride1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1659-2ML - Milliliter72162-16599753f697-5f38-4923-a7d1-46e94ec8d01712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1659TRI-VITE DROPS WITH FLUORIDE (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D) SOLUTION [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20240622_15c78a03-17d7-43af-978f-1a64bd2240fe.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 SolutionSCD15c78a03-17d7-43af-978f-1a64bd2240fe2
1365984ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral SolutionSY15c78a03-17d7-43af-978f-1a64bd2240fe2
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 SolutionSY15c78a03-17d7-43af-978f-1a64bd2240fe2
1365984vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY15c78a03-17d7-43af-978f-1a64bd2240fe2
1365984vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY15c78a03-17d7-43af-978f-1a64bd2240fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1659-2721621659021 BOTTLE, DROPPER in 1 CARTON (72162-1659-2) / 50 mL in 1 BOTTLE, DROPPER2018-07-25NoNoHistorical