NDC Package 58809-650-08 Vanalice

Piperonyl Butoxide,Pyrethrum Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

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:

58809-650-08

Package Description:

237 mL in 1 BOTTLE

Product Code:

58809-650

Proprietary Name:

Vanalice

Non-Proprietary Name:

Piperonyl Butoxide, Pyrethrum

Substance Name:

Piperonyl Butoxide; Pyrethrum Extract

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

11-Digit NDC Billing Format:

58809065008

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

237 ML

NDC to 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

Product Type:

Human Otc Drug

Labeler Name:

Gm Pharmaceuticals, Inc

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.

Active Ingredient(s):

Sample Package:

FDA Application Number:

M031

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

08-05-2018

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

58809 - Gm Pharmaceuticals, Inc
- 58809-650 - Vanalice
  - 58809-650-08 - 237 mL in 1 BOTTLE

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 disclaimer below.

Frequently Asked Questions

What is NDC 58809-650-08?

The NDC Packaged Code 58809-650-08 is assigned to a package of 237 ml in 1 bottle of Vanalice, a human over the counter drug labeled by Gm Pharmaceuticals, Inc. The product's dosage form is gel and is administered via topical form.

Is NDC 58809-650 included in the NDC Directory?

Yes, Vanalice with product code 58809-650 is active and included in the NDC Directory. The product was first marketed by Gm Pharmaceuticals, Inc on August 05, 2018 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 NDC billing unit for package 58809-650-08?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 237.

What is the 11-digit format for NDC 58809-650-08?

The 11-digit format is 58809065008. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58809-650-08	5-4-2	58809-0650-08

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