NDC Package 83191-003-03 Level Select Menthol Camphor Roll On

10% Menthol,5% Camphor Roll On Gel Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83191-003-03
Package Description:
70.87 g in 1 TUBE, WITH APPLICATOR
Product Code:
Proprietary Name:
Level Select Menthol Camphor Roll On
Non-Proprietary Name:
10% Menthol, 5% Camphor Roll On Gel
Substance Name:
Camphor (synthetic); Menthol
Usage Information:
Adults and Children 12 years and older:Apply a thin layer of gel to affected area no more than 3-4 times dailyAllow gel to absorb before covering areaWash hands, if used, after appliation with soap and water_______________________________________________________________Children under 12 years of age:Consult a physician before use
11-Digit NDC Billing Format:
83191000303
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Kandenwood Llc
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Sample Package:
No
FDA Application Number:
M017
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
02-13-2023
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 83191-003-03?

The NDC Packaged Code 83191-003-03 is assigned to a package of 70.87 g in 1 tube, with applicator of Level Select Menthol Camphor Roll On, a human over the counter drug labeled by Kandenwood Llc. The product's dosage form is gel and is administered via topical form.

Is NDC 83191-003 included in the NDC Directory?

Yes, Level Select Menthol Camphor Roll On with product code 83191-003 is active and included in the NDC Directory. The product was first marketed by Kandenwood Llc on February 13, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83191-003-03?

The 11-digit format is 83191000303. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-283191-003-035-4-283191-0003-03