Multi-Vitamin Drops with Fluoride and Iron

Product NDC
58657-327
11-digit product format
586570327
Labeler code
58657
Product ID
58657-327_41b5d787-acb5-89e9-e063-6294a90aa957
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate 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; FERROUS SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE
Active strength
5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/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 6 [Chemical/Ingredient], 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 Drops with Fluoride and Iron
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-10 mg/mL
THIAMINE HYDROCHLORIDE8 mg/mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM.4 mg/mL
NIACINAMIDE.6 mg/mL
PYRIDOXINE HYDROCHLORIDE.25 mg/mL
FERROUS SULFATE.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
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
39R4TAN1VTInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5609742-e456-4409-bca9-706b0ea90d35Available 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
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
58657-327-50Multi-Vitamin Drops with Fluoride and Iron1 in 1 BOXLIQUID111
58657-327-50Multi-Vitamin Drops with Fluoride and Iron50 mL in 1 BOTTLE, DROPPERLIQUID5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-327-50ML - Milliliter58657-3273bf095d6-061a-4521-b73c-319a286baae512017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-327MULTI-VITAMIN DROPS WITH FLUORIDE AND IRON (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE AND SODIUM FLUORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]10Current NDC, Legacy NDC, 2 package rows20241126_d5609742-e456-4409-bca9-706b0ea90d35.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 Drops with Fluoride and IronVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE AND SODIUM FLUORIDEMethod Pharmaceuticals, LLCd5609742-e456-4409-bca9-706b0ea90d352025-10-21Warnings, Adverse reactionsExact identifier
ndc (product): 58657-327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-327-50586570327501 BOTTLE, DROPPER in 1 BOX (58657-327-50) / 50 mL in 1 BOTTLE, DROPPER2017-02-240000-00-00NoNoCurrent