Over-the-counter drug · OTC MONOGRAPH DRUG
Vanalice (Piperonyl butoxide, pyrethrum) NDC 58809-650
Piperonyl butoxide 35 mg/mL; Pyrethrum extract 3 mg/mL · Gel · Topical · GM Pharmaceuticals, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58809-650-08 | 5880906500858809065008 | 237 mL in 1 BOTTLE (58809-650-08)Marketed from Aug 5, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vanalice
- Generic name (nonproprietary)
- piperonyl butoxide, pyrethrum
- Active ingredients
- Piperonyl butoxide — 35 mg/mLPyrethrum extract — 3 mg/mL
- Dosage form
- Gel
- Route
- Topical
- Labeler
- GM Pharmaceuticals, INCNDC labeler code 58809
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 031
- Marketing start
- Listing expires
- Identifiers
- Product ID 58809-650_4510adbf-3258-b683-e063-6394a90a53d2SPL ID 4510adbf-3258-b683-e063-6394a90a53d2SPL set ID c0205fa6-c8f4-4a28-9341-56a120843706RxCUI 2058503, 2058508UNII LWK91TU9AH, ZUM06L90GV
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458809065008followed by a unit qualifier and the quantityPackage 58809-0650-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses treats head, pubic (crab), and body lice
Excerpt only. Read the full label for complete information.
About NDC 58809-650
- What is NDC 58809-650?
- 58809-650 is the product NDC for Vanalice, Piperonyl butoxide 35 mg/mL; Pyrethrum extract 3 mg/mL gel, listed with the FDA by GM Pharmaceuticals, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vanalice (Piperonyl butoxide, Pyrethrum).
- What is the active ingredient?
- Piperonyl butoxide, Pyrethrum extract.
- Who is the labeler?
- GM Pharmaceuticals, INC, NDC labeler code 58809. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vanalice?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 031
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| CVS 3 Step Lice Solutionpiperonyl butoxide, pyrethrum extract | — | KitTopical | CVS | 69842-255 |
| CVS 3 Step Lice Solutionpiperonyl butoxide, pyrethrum extract | — | KitTopical | CVS | 69842-255 |
| Major Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | Major Pharmaceuticals | 0904-7349 |
| Kroger Complete Lice Treatment Kitpiperonyl butoxide, pyrethrum extract | — | KitTopical | The Kroger Co | 30142-252 |
| Rite Aid Complete Lice Elimination Kitpiperonyl butoxide, pyrethrum extract | — | KitTopical | Rite Aid | 11822-6611 |
| Kroger Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | The Kroger Co | 30142-253 |
| Rite Aid Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | Rite Aid Corp | 11822-6616 |
| Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | Weeks & Leo Co., Inc. | 11383-310 |
| Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | PHARMACY VALUE ALLIANCE LLC | 68016-253 |
| Mata Piojos Licepiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | GRANDALL DISTRIBUTING, LLC | 48201-006 |
| ABC Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | Weeks & Leo Co., Inc. | 11383-312 |
| El Piojito Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | Pharmadel | 55758-253 |
| Topcare Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | Topco Associates, LLC | 76162-253 |
| Topcare Complete Lice Treatment Kitpiperonyl butoxide, pyrethrum extract | — | KitTopical | Topco Associates, LLC | 76162-255 |
| Premier Value Lice Treatment Kitpiperonyl butoxide, pyrethrum extract | — | KitTopical | PHARMACY VALUE ALLIANCE LLC | 68016-552 |
| Walgreens Lice Killingpiperonyl butoxide, pyrethrum extract | Piperonyl butoxide 4 g/100mL; Pyrethrum extract .33 g/100mL | ShampooTopical | Walgreens CO | 0363-1253 |
| Leader Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | LEADER/ Cardinal Health 110, Inc. | 70000-0633 |
| Walgreens Lice Eliminationpiperonyl butoxide, pyrethrum extract | — | KitTopical | Walgreens | 0363-3255 |
| Meijer Complete Lice Treatment Kitpiperonyl butoxide, pyrethrum extract | — | KitTopical | Meijer, Inc. | 79481-2550 |
| Meijer Lice Killingpiperonyl butoxide, pyrethrum extract | Pyrethrum extract .33 g/100mL; Piperonyl butoxide 4 g/100mL | ShampooTopical | Meijer, Inc. | 79481-2530 |
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