Tri-Vite Drops with Fluoride

Product NDC: 58657-323
Requested package NDC: 58657-323-50
11-digit product format: 586570323
Labeler code: 58657
Product ID: 58657-323_41b76910-3e17-3254-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; .25; 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
Ingredient	Strength
VITAMIN A	35 mg/mL
ASCORBIC ACID	.25 mg/mL
VITAMIN D	1500 [iU]/mL
SODIUM FLUORIDE	400 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81G40H8B0T	Internal UNII lookup
PQ6CK8PD0R	Internal UNII lookup
9VU1KI44GP	Internal UNII lookup
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1365980	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
003181d4-5412-4ffe-b99d-880f2010e3ad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-02-11	Tri-Vite Drops with Fluroide 0_25 mg
2020-02-11	Tri-Vite Drops with Fluroide 0_25 mg
2020-01-31	Tri-Vite Drops with Fluroide 0_25 mg
2020-01-31	Tri-Vite Drops with Fluroide 0_25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58657-323-50	Tri-Vite Drops with Fluoride	50 mL in 1 BOTTLE, DROPPER	SOLUTION	50		7
58657-323-50	Tri-Vite Drops with Fluoride	1 in 1 CARTON	SOLUTION	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-323-50	ML - Milliliter	58657-323	729a6e64-0967-4b7d-a67d-76e13039de07	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-323	TRI-VITE DROPS WITH FLUORIDE (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D) SOLUTION [METHOD PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241126_003181d4-5412-4ffe-b99d-880f2010e3ad.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tri-Vite Drops with Fluoride	ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D	Method Pharmaceuticals, LLC	003181d4-5412-4ffe-b99d-880f2010e3ad	2025-10-21	Warnings, Adverse reactions	Exact identifier ndc (package): 58657-323-50 ndc (product): 58657-323 ndc11 (package): 58657032350

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PQ6CK8PD0R	ASCORBIC ACID	50-81-7	ASCORBIC ACID
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE
81G40H8B0T	VITAMIN A	11103-57-4	VITAMIN A
9VU1KI44GP	VITAMIN D	1406-16-2	VITAMIN D

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1365980	vitamin C 35 MG/mL / cholecalciferol 0.01 MG/mL / sodium fluoride 0.55 MG/mL / vitamin A palmitate 450 MCG/mL Oral Solution	PSN	003181d4-5412-4ffe-b99d-880f2010e3ad	7
1365980	ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SCD	003181d4-5412-4ffe-b99d-880f2010e3ad	7
1365980	sodium fluoride 0.55 MG (fluoride ion 0.25 MG) / vitamin A palmitate 450 MCG (1500 UNT) / vitamin C 35 MG / vitamin D3 10 MCG (400 UNT) per ML Oral Solution	SY	003181d4-5412-4ffe-b99d-880f2010e3ad	7
1365980	vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SY	003181d4-5412-4ffe-b99d-880f2010e3ad	7
1365980	vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution	SY	003181d4-5412-4ffe-b99d-880f2010e3ad	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-323-50	58657032350	1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPER	2018-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tri-Vite Drops with Fluroide 0_25 mg	Method Pharmaceuticals, LLC	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	7