Over-the-counter drug · NDA
Nicorette Cherry Peppermint (nicotine polacrilex) NDC 0135-8071
Nicotine 4 mg/1 · Lozenge · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-8071-20 | 00135807120 | 1 VIAL in 1 PACKAGE (0135-8071-20) / 20 LOZENGE in 1 VIALMarketed from Apr 1, 2026 | |
| 0135-8071-81 | 00135807181 | 3 VIAL in 1 PACKAGE (0135-8071-81) / 27 LOZENGE in 1 VIALMarketed from Apr 1, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Nicorette Cherry PeppermintSuffix: Cherry Peppermint
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- Haleon US Holdings LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022360
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0135-8071_3724f342-04db-e129-e063-6294a90a6c7dSPL ID 3724f342-04db-e129-e063-6294a90a6c7dSPL set ID 35438b53-2760-bcfe-e063-6394a90a65c0RxCUI 359817, 359818, 968849, 968851UNII 6M3C89ZY6R
- Pharmacologic class
- Cholinergic Nicotinic Agonist
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400135807120followed by a unit qualifier and the quantityPackage 00135-8071-20. 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)
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022360
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 |
|---|---|---|---|---|
| Nicorette Peppermintnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-8050 |
| Nicorettenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-1500 |
| Nicorette Peppermintnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-8060 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-2800 |
| Nicorette Cherry Peppermintnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-8070 |
| Nicorettenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Haleon US Holdings LLC | 0135-0508 |