Prescription and over-the-counter medicine
Nicotine Brand names: Nicorette, Habitrol, Nicoderm, Nicotrol; first approved as Nicoderm Cq
Nicotine (Nicorette) is a prescription and over-the-counter medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 69 generic labelers, and pharmacies paid $1.87 per nicotine 21 mg/24hr patch in the October 7, 2026 NADAC survey; its other strengths are brand-only, $12.96 per mL (Nicotrol ns 10 mg/mL spray).
- Generic listed
Check it at the source: the nicotine FDA label on DailyMed (effective July 25, 2024, Dr. Reddys Laboratories Inc.); the NDA 20165 record on Drugs@FDA; every nicotine label on DailyMed.
Highlights of the record
FDA label of July 25, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagereduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Forms and strengths
- 2 mg
- 4 mg
- 7 mg
- 14 mg
- 21 mg
- 7 mg/24h
- 10 mg/ml
- 14 mg/24h
- 21 mg/24h
Lozenge; gum (chewing); extended-release patch; patch; extended-release film.
On the market
- Earliest approval on file
- November 7, 1991 Nicoderm Cq, Chattem Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first October 20, 1997; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 76 of which 69 under generic applications, 21 under brand applications, repackagers included; 16 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $1.87 per patch Nicotine 21 mg/24hr patch
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2014 0 Class I among all firms' recalls; latest May 14, 2026
- FAERS reports
- 60,636 through July 30, 2026
What is nicotine used for?
From the label: indications and usagereduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Conditions named in the indications of nicotine's FDA labels, with every medicine labeled for each:
From other nicotine labelsQuitting smoking: INDICATIONS AND USAGE NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms.
FDA pharmacologic class: Cholinergic Nicotinic Agonist.
Source: FDA drug label (Nicotine transdermal system), Dr. Reddys Laboratories Inc., effective July 25, 2024 (SPL set e2391b29-9bac-fc09-f2a5-a3370bc4e2c3), via openFDA; the full label on DailyMed
Is there a generic for nicotine (Nicorette)?
The FDA approved the first generic nicotine on October 20, 1997. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nicotine from 69 labelers under a generic (ANDA) application and from 21 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 1997 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nicotine (Nicorette)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.87 per Nicotine 21 mg/24hr patch, up 26% from $1.49 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nicotine 21 mg/24hr patch (generic)
- Nicotrol ns 10 mg/mL spray (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft nicotine 14 mg/24hr patch | Generic | $1.85 per patch | n/a | +22% |
| Ft nicotine 2 mg chewing gum | Generic | $0.233 per unit | n/a | +2% |
| Ft nicotine 2 mg lozenge | Generic | $0.347 per lozenge | n/a | -0.9% |
| Ft nicotine 2 mg mini lozenge | Generic | $0.374 per lozenge | n/a | +8% |
| Ft nicotine 21 mg/24hr patch | Generic | $1.87 per patch | n/a | +26% |
| Ft nicotine 4 mg chewing gum | Generic | $0.287 per unit | n/a | +7% |
| Ft nicotine 4 mg lozenge | Generic | $0.344 per lozenge | n/a | +3% |
| Ft nicotine 4 mg mini lozenge | Generic | $0.389 per lozenge | n/a | +8% |
| Ft nicotine 7 mg/24hr patch | Generic | $1.82 per patch | n/a | +18% |
| Gnp nicotine 2 mg chewing gum | Generic | $0.233 per unit | n/a | +2% |
| Gnp nicotine 2 mg lozenge | Generic | $0.347 per lozenge | n/a | -0.9% |
| Gnp nicotine 2 mg mini lozenge | Generic | $0.374 per lozenge | n/a | +8% |
| Gnp nicotine 21 mg/24hr patch | Generic | $1.87 per patch | n/a | +26% |
| Gnp nicotine 4 mg chewing gum | Generic | $0.287 per unit | n/a | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nicotine been recalled?
The FDA's Enforcement Report lists 8 recalls naming nicotine since 2014: 0 Class I (the most serious), 0 Class II, 8 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 14, 2026 | Class III | AVEVA Drug Delivery Systems, Inc. | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of … |
| August 19, 2014 | Class III | Perrigo Holland Inc | Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges. |
| February 20, 2014 | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nicotine label say about other medicines?
The nicotine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name nicotine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
| Caffeine | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
| Imipramine | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
| Isoproterenol | drug interactions (prescription label) | May Require an Increase in Dose at Cessation of Smoking Possible Mechanism Adrenergic agonists (e.g. isoproterenol, phenylephrine) Decrease in circulating catecholamines with smoking cessation. |
| Labetalol | drug interactions (prescription label) | Adrenergic antagonists (e.g. prazosin, labetalol) Decrease in circulating catecholamines with smoking cessation. |
| Oxazepam | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
| Phenylephrine | drug interactions (prescription label) | May Require an Increase in Dose at Cessation of Smoking Possible Mechanism Adrenergic agonists (e.g. isoproterenol, phenylephrine) Decrease in circulating catecholamines with smoking cessation. |
| Prazosin | drug interactions (prescription label) | Adrenergic antagonists (e.g. prazosin, labetalol) Decrease in circulating catecholamines with smoking cessation. |
| Propranolol | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
| Theophylline | drug interactions (prescription label) | May Require a Decrease in Dose at Cessation of Smoking: Acetaminophen, caffeine, imipramine, oxazepam, pentazocine, propranolol, or other beta-blockers, theophylline; Possible Mechanism: Deinduction of hepatic enzymes on smoking cessation. |
Other labels that name nicotine
Source: FDA drug label (Nicotine transdermal system), Dr. Reddys Laboratories Inc., effective July 25, 2024 (SPL set e2391b29-9bac-fc09-f2a5-a3370bc4e2c3), via openFDA; the full label on DailyMed
What do FAERS reports show for nicotine?
The FDA Adverse Event Reporting System holds 60,636 reports that list nicotine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,992 are coded as a death and 6,707 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Nicotine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other