FDA.reportPublic FDA data

Tri-Vit with Fluoride Drops

Product NDC
0603-1785
Requested package NDC
0603-1785-47
11-digit product format
006031785
Labeler code
0603
Product ID
0603-1785_af6dced4-37c8-47d3-82cb-fbc48cbabf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ascorbic acid and cholecalciferol and sodium fluoride and vitamin A palmitate
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Pharmaceutical
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1995-04-01
Marketing end
2021-02-28
Substance
VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE
Active strength
1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL
Pharmacologic classes
Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-17850603-1785-47DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1785-47ML - Milliliter0603-1785cbf8ac97-2a9d-454e-a667-3b959a671bdc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0RTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41TRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7TRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
VITAMIN A PALMITATEACTIVE INGREDIENT1D1K0N0VVCTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0RTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41TRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
VITAMIN A PALMITATEACTIVE MOIETY1D1K0N0VVCTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RTRI-VIT WITH FLUORIDE DROPS (ASCORBIC ACID AND CHOLECALCIFEROL AND SODIUM FLUORIDE AND VITAMIN A PALMITATE) SOLUTION [QUALITEST PHARMACEUTICALS]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0603-1785-47006031785471 BOTTLE, PLASTIC in 1 CARTON (0603-1785-47) > 50 mL in 1 BOTTLE, PLASTIC1995-04-012021-02-28NoNoCurrent