Vanalice Gel
NDC Package 58809-650-08

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

Package Information

Vanalice (piperonyl butoxide, pyrethrum) gel is important: Read warnings before use Adults and children 2 years and over:Inspectcheck each household member with a magnifying glass in bright light for lice/nits (eggs)look for tiny nits near scalp, beginning at back of neck and behind earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this productTreatapply thoroughly to DRY HAIR or other affected area. This formulation utilizes a gel delivery system. Marketed by Gm Pharmaceuticals, Inc, this product is identified by NDC 58809-650 and is authorized under FDA application M031.

Identification & Billing

NDC Package Code
58809-650-08
Package Description
237 mL in 1 BOTTLE
Product Code
58809-650
11-Digit Billing Format
58809065008
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
RxNorm Crosswalk
  • RxCUI: 2058503 - piperonyl butoxide 3.5 % / pyrethrins 0.3 % Topical Gel
  • RxCUI: 2058503 - piperonyl butoxide 0.035 MG/MG / pyrethrins 0.003 MG/MG Topical Gel
  • RxCUI: 2058508 - VanaLice 3.5 % / 0.03 % Topical Gel
  • RxCUI: 2058508 - piperonyl butoxide 0.035 MG/MG / pyrethrins 0.003 MG/MG Topical Gel [Vanalice]
  • RxCUI: 2058508 - Vanalice (piperonyl butoxide 3.5 % / pyrethrins 0.03 % ) Topical Gel

Clinical Specifications

Proprietary Name
Vanalice
Non-Proprietary Name
Piperonyl Butoxide, Pyrethrum
Substance Name
Piperonyl Butoxide; Pyrethrum Extract
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Important: Read warnings before use Adults and children 2 years and over:Inspectcheck each household member with a magnifying glass in bright light for lice/nits (eggs)look for tiny nits near scalp, beginning at back of neck and behind earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this productTreatapply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.allow product to remain for 10 minutes, but no longerwash area thoroughly with warm water and soap or shampoo for head lice, towel dry hair and comb out tanglesRemove lice and their eggs (nits)use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).hair should remain slightly damp while removing nitsif hair dries during combing, dampen slightly with waterfor head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.lift a 1-to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.pin back each strand of hair after combingclean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.check daily for any lice/nits that you misseda second treatment must be done in 7 to 10 days to kill any newly hatched liceif infestation continues, see a doctor for other treatmentsChildren under 2 years: ask a doctor

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals, Inc
Product Type
Human Otc Drug
FDA Application #
M031
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-05-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 58809-650-08 identifies a specific commercial package of 237 ml in 1 bottle of Vanalice, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. This gel is formulated for topical use and contains piperonyl butoxide; pyrethrum extract as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gm Pharmaceuticals, Inc on August 05, 2018. The current certification is valid through December 31, 2026.

How is this Gm Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58809065008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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)
58809-650-08
11-Digit CMS (5-4-2)
58809-0650-08

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