Vanalice Gel
NDC 58809-650

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58809-650?
  4. Vanalice Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Vanalice (piperonyl butoxide, pyrethrum) is a OTC MONOGRAPH DRUG-approved product labeled by Gm Pharmaceuticals, Inc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a gel for topical administration. This product entry covers the primary NDC 58809-650 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58809-650
Proprietary Name:
Vanalice
Non-Proprietary Name: [1]
Piperonyl Butoxide, Pyrethrum
Substance Name: [2]
Piperonyl Butoxide; Pyrethrum Extract
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Gm Pharmaceuticals, Inc
Labeler Code:
58809
Product Label ID:
c0205fa6-c8f4-4a28-9341-56a120843706
FDA Application Number: [6]
M031
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
08-05-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58809-650?

The NDC code 58809-650 is assigned by the FDA to the product Vanalice. It is commonly known by its generic name, piperonyl butoxide, pyrethrum. This pharmaceutical product is labeled by Gm Pharmaceuticals, Inc and is currently categorized as listed product. The medication is a gel administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58809-650-08. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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

What are Active Ingredients of this product?

An 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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

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

Patient Education

Pyrethrin and Piperonyl Butoxide Topical


Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An 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.
What kind of product is this? Indicates 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".