FDA.reportPublic FDA data

Tri-Vite Drops with Fluoride

Product NDC
58657-324
11-digit product format
586570324
Labeler code
58657
Product ID
58657-324_41b76910-3e18-3254-e063-6294a90adb54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D
Dosage form
SOLUTION
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tri-Vite Drops with Fluoride
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58657-324-502020-02-11C16284748780-19d75b9d0-0b1a-f424-e053-dadaa90a57ceTri-Vite Drops with Fluroide 0_5 mg
58657-324-502020-02-11C16284748780-19d75b9d0-0b1a-f424-e053-dadaa90a57ceTri-Vite Drops with Fluroide 0_5 mg
58657-324-502020-01-31C16284748780-19d75b9d0-0b1a-f424-e053-dadaa90a57ceTri-Vite Drops with Fluroide 0_5 mg
58657-324-502020-01-31C16284748780-19d75b9d0-0b1a-f424-e053-dadaa90a57ceTri-Vite Drops with Fluroide 0_5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-324-50Tri-Vite Drops with Fluoride1 in 1 CARTONSOLUTION17
58657-324-50Tri-Vite Drops with Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-324-50ML - Milliliter58657-32492d8a941-cbe7-4308-93a1-5d625dec2b6912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-324TRI-VITE DROPS WITH FLUORIDE (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D) SOLUTION [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20241126_5acff360-8d44-44d7-864d-52f213501d03.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
1365984ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSCD5acff360-8d44-44d7-864d-52f213501d037
1365984ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral SolutionSY5acff360-8d44-44d7-864d-52f213501d037
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 SolutionSY5acff360-8d44-44d7-864d-52f213501d037
1365984vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY5acff360-8d44-44d7-864d-52f213501d037
1365984vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY5acff360-8d44-44d7-864d-52f213501d037
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 startMarketing endSampleExclude flagStatus
58657-324-50586570324501 BOTTLE, DROPPER in 1 CARTON (58657-324-50) / 50 mL in 1 BOTTLE, DROPPER2018-07-250000-00-00NoNoCurrent