Multi-vitamin Fluoride Drops
NDC Package 52959-593-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Multi-vitamin Fluoride Drops is supplementation of the diet with vitamins A, C and D.Multi-Vitamin Fluoride Drops 0.25 mg also provide fluoride for caries prophylaxis.The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Fluoride 0.25 mg drops. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 52959-593.

Identification & Billing

NDC Package Code
52959-593-50
Package Description
50 mL in 1 BOTTLE, DROPPER
Product Code
52959-593
11-Digit Billing Format
52959059350
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk
  • RxCUI: 1234482 - ascorbic 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 Solution
  • RxCUI: 1234482 - ascorbic 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 Solution
  • RxCUI: 1234482 - vitamin 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 Solution
  • RxCUI: 1234482 - vitamin 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 Solution
  • RxCUI: 1234482 - vitamin 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 Solution

Clinical Specifications

Proprietary Name
Multi-vitamin Fluoride Drops
Dosage Form
-
Usage Information
Supplementation of the diet with vitamins A, C and D.Multi-Vitamin Fluoride Drops 0.25 mg also provide fluoride for caries prophylaxis.The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Fluoride 0.25 mg drops. (see Dosage and Administration).Multi-Vitamin Fluoride 0.25 mg drops supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-04-2011
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52959-593-50 identifies a specific commercial package of 50 ml in 1 bottle, dropper of Multi-vitamin Fluoride Drops, labeled by H.j. Harkins Company, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 50 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by H.j. Harkins Company, Inc. on May 04, 2011. The current certification is valid through December 31, 2017.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959059350. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52959-593-50
11-Digit CMS (5-4-2)
52959-0593-50

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.