About this document
Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020385
· View the label on DailyMed
Revision date stated in the text: June 2024
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Drug information for Nicotrol Nasal
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Cholinergic Nicotinic Agonist |
| Active ingredient |
Nicotine 10 mg/mL
|
| Dosage form |
Spray, metered |
| Route |
Nasal |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
PFIZER INC |
| FDA approval |
NDA 020385New Drug Application (NDA)
Approved March 22, 1996
|
| Reference listed drug |
This is the reference listed drug (RLD) that generics are compared with. |
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
10 mg/mL – 10 ml in 1 bottle, spray / 4 in 1 box
NDC 0009-5401-01
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.