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
.ALPHA.-TOCOPHEROL SUCCINATE, D-5 [iU]/mL
ASCORBIC ACID35 mg/mL
CHOLECALCIFEROL400 [iU]/mL
FERROUS SULFATE10 mg/mL
NIACINAMIDE8 mg/mL
PYRIDOXINE HYDROCHLORIDE.4 mg/mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM.6 mg/mL
SODIUM FLUORIDE.25 mg/mL
THIAMINE HYDROCHLORIDE.5 mg/mL
VITAMIN A PALMITATE1500 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLU4B53JYVE, PQ6CK8PD0R, 1C6V77QF41, 39R4TAN1VT, 25X51I8RD4, 68Y4CF58BV, 20RD1DZH99, 8ZYQ1474W7, M572600E5P, 1D1K0N0VVC

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

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