Multi-Vitamin with Fluoride

Product NDC
58657-325
Requested package NDC
58657-325-50
11-digit product format
586570325
Labeler code
58657
Product ID
58657-325_41b6304f-4d34-9022-e063-6394a90af95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE and SODIUM FLUORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-24
Substance
.ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE
Active strength
5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multi-Vitamin with Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VITAMIN A PALMITATE5 [iU]/mL
ASCORBIC ACID35 mg/mL
CHOLECALCIFEROL400 [iU]/mL
.ALPHA.-TOCOPHEROL SUCCINATE, D-2 ug/mL
THIAMINE HYDROCHLORIDE8 mg/mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM.4 mg/mL
CYANOCOBALAMIN.6 mg/mL
NIACINAMIDE.25 mg/mL
PYRIDOXINE HYDROCHLORIDE.5 mg/mL
SODIUM FLUORIDE1500 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1D1K0N0VVCInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup
1C6V77QF41Internal UNII lookup
LU4B53JYVEInternal UNII lookup
M572600E5PInternal UNII lookup
20RD1DZH99Internal UNII lookup
P6YC3EG204Internal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234482Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
880df628-5bba-4dc4-b557-1fcc822adba8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-325-50Multi-Vitamin with Fluoride1 in 1 BOXLIQUID110
58657-325-50Multi-Vitamin with Fluoride50 mL in 1 BOTTLE, DROPPERLIQUID5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-325-50ML - Milliliter58657-3257657d4ac-b091-4f30-9637-1122e7d6107d12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-325MULTI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 2 package rows20241126_880df628-5bba-4dc4-b557-1fcc822adba8.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi-Vitamin with FluorideVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLC880df628-5bba-4dc4-b557-1fcc822adba82025-10-21Warnings, Adverse reactionsExact identifier
ndc (package): 58657-325-50
ndc (product): 58657-325
ndc11 (package): 58657032550

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234482ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSCD880df628-5bba-4dc4-b557-1fcc822adba810
1234482ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY880df628-5bba-4dc4-b557-1fcc822adba810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-325-50586570325501 BOTTLE, DROPPER in 1 BOX (58657-325-50) / 50 mL in 1 BOTTLE, DROPPER2017-02-240000-00-00NoNoCurrent