Over-the-counter drug · NDA
Nicorette White Ice Mint (nicotine polacrilex) NDC 0135-0475
Nicotine 4 mg/1 · Gum, Chewing · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0475-01 | 00135047501 | 1 BLISTER PACK in 1 CARTON (0135-0475-01) / 20 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 29, 2009 | |
| 0135-0475-02 | 00135047502 | 1 BLISTER PACK in 1 CARTON (0135-0475-02) / 100 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 29, 2009 | |
| 0135-0475-05 | 00135047505 | 1 BLISTER PACK in 1 CARTON (0135-0475-05) / 160 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 29, 2009 | |
| 0135-0475-08 | 00135047508 | 20 GUM, CHEWING in 1 CARTON (0135-0475-08)Marketed from Jun 29, 2009 | |
| 0135-0475-17 | 00135047517 | 1 BLISTER PACK in 1 CARTON (0135-0475-17) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 29, 2009 | |
| 0135-0475-18 | 00135047518 | 2 CARTON in 1 PACKAGE (0135-0475-18) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Aug 1, 2014 | |
| 0135-0475-19 | 00135047519 | 12 BLISTER PACK in 1 CARTON (0135-0475-19) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 1, 2018 | |
| 0135-0475-20 | 00135047520 | 18 BLISTER PACK in 1 CARTON (0135-0475-20) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Dec 3, 2018 |
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 White Ice MintSuffix: White Ice Mint
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Haleon US Holdings LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020066
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0135-0475_1f929250-cbfa-d6eb-e063-6394a90a7281SPL ID 1f929250-cbfa-d6eb-e063-6394a90a7281SPL set ID 673fd19f-69b3-4f73-b9b4-18b5f4cbf69cRxCUI 105071, 209326, 311975, 314119UNII 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
N400135047501followed by a unit qualifier and the quantityPackage 00135-0475-01. 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 020066
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 Spearmint Burstnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0355 |
| Nicorette Spearmint Burstnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0533 |
| Nicorette Cinnamon Surgenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0467 |
| Nicorette Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0230 |
| Nicorette 4mg Cinnamon Surgenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store products, Inc. | 66715-8123 |
| Nicorette 4mg Fruit Chill Gum, Lil Drug Storenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store Products, Inc. | 66715-8124 |
| Nicorette 4mg White Ice Mint Gum, Lil Drug Storenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Lil' Drug Store Products, Inc. | 66715-8125 |
| Nicorette Fruit Chill nicotine polacrilexnicotine | Nicotine 4 mg/1 | Gum, ChewingOral | Lil' Drug Store Products, Inc. | 29485-5270 |
| Nicorette White Mint nicotine polacrilexnicotine | Nicotine 4 mg/1 | Gum, ChewingOral | Lil' Drug Store Products, Inc. | 29485-5271 |
| Nicorette Fruit Chillnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0242 |
| Nicorette Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Haleon US Holdings LLC | 0135-0158 |