Tri-Vit With Fluoride And Iron Drops

Product NDC: 0603-1787
Requested package NDC: 0603-1787-47
11-digit product format: 006031787
Labeler code: 0603
Product ID: 0603-1787_8cd59725-07c6-4782-927a-86be94418028
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vitamin a palmitate and ascorbic acid and cholecalciferol and ferrous sulfate and sodium fluoride
Dosage form: SOLUTION
Route: ORAL
Labeler: Par Pharmaceutical
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1997-11-17
Marketing end: 2021-03-31
Substance: VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; SODIUM FLUORIDE
Active strength: 1500 [iU]/mL; mg/mL; [iU]/mL; mg/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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-1787	0603-1787-47	D	Discontinued by firm		2026-10-05

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-1787-47	ML - Milliliter	0603-1787	6343baa9-0693-43da-b834-36111be8f14d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASCORBIC ACID	ACTIVE INGREDIENT	PQ6CK8PD0R	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
FERROUS SULFATE	ACTIVE INGREDIENT	39R4TAN1VT	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
VITAMIN A PALMITATE	ACTIVE INGREDIENT	1D1K0N0VVC	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
ASCORBIC ACID	ACTIVE MOIETY	PQ6CK8PD0R	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
IRON	ACTIVE MOIETY	E1UOL152H7	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
VITAMIN A	ACTIVE MOIETY	81G40H8B0T	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRI-VIT WITH FLUORIDE AND IRON DROPS (VITAMIN A PALMITATE AND ASCORBIC ACID AND CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION) SOLUTION [QUALITEST PHARMACEUTICALS]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1D1K0N0VVC	VITAMIN A PALMITATE	79-81-2	VITAMIN A PALMITATE
PQ6CK8PD0R	ASCORBIC ACID	50-81-7	ASCORBIC ACID
1C6V77QF41	CHOLECALCIFEROL	67-97-0	CHOLECALCIFEROL
39R4TAN1VT	FERROUS SULFATE	7782-63-0	FERROUS SULFATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-1787-47	00603178747	1 BOTTLE, PLASTIC in 1 CARTON (0603-1787-47) > 50 mL in 1 BOTTLE, PLASTIC	1997-11-17	2021-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRI-VIT WITH FLUORIDE 0.25 mg AND IRON DROPS Rx only	Par Pharmaceutical	2019-11-11	HUMAN PRESCRIPTION DRUG LABEL	9