58657-327 NDC - MULTI-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)

Drug Information

  • Product NDC: 58657-327
  • Proprietary Name: Multi-Vitamin Drops with Fluoride and Iron
  • Non Proprietary Name: VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDE
  • Active Ingredient(s): 5 [iU]/mL .ALPHA.-TOCOPHEROL SUCCINATE, D-; 35 mg/mL ASCORBIC ACID; 400 [iU]/mL CHOLECALCIFEROL; 10 mg/mL FERROUS SULFATE; 8 mg/mL NIACINAMIDE; .4 mg/mL PYRIDOXINE HYDROCHLORIDE; .6 mg/mL RIBOFLAVIN 5'-PHOSPHATE SODIUM; .25 mg/mL SODIUM FLUORIDE; .5 mg/mL THIAMINE HYDROCHLORIDE; 1500 [iU]/mL VITAMIN A PALMITATE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Method Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/24/2017

Package Information

No. Package Code Package Description Billing Unit
158657-327-501 BOTTLE, DROPPER in 1 BOX (58657-327-50) / 50 mL in 1 BOTTLE, DROPPERML

NDC Record

Field Name Field Value Definition
PRODUCT NDC58657-327The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMulti-Vitamin Drops with Fluoride and IronThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEVITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/24/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEMethod Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME.ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 
ACTIVE INGRED UNIT[iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL 
PHARM CLASSESAnalogs/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] 

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This page was last updated on: 12/19/2025

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