Nicotine
Nicotine is an ingredient found in multiple stop-smoking products — including gum, lozenges, nasal spray, and inhaler — used to reduce nicotine withdrawal symptoms and cravings when quitting smoking.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 521 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Nicotine replacement (gum, lozenges, patches, nasal spray and more) eases withdrawal and cravings when you quit smoking by acting on the same brain receptors cigarettes do, without the harm of burning tobacco, and it is a familiar first step, on the market since the 1980s and available as a generic. Most people tolerate it well, noticing mouth irritation, hiccups or nausea with gum and lozenges, or a runny, irritated nose with the spray. Stop and get help for signs of too much nicotine, such as vomiting, dizziness or a racing heartbeat, and check with your doctor first if you have heart disease, uncontrolled high blood pressure or are pregnant.
Clinical pearls
- Start on your quit day and use it on a set schedule that tapers down, not only when a craving hits.
- Avoid eating or drinking for 15 minutes before and during gum or lozenge use, since it blunts absorption.
- Quitting smoking can raise levels of caffeine, theophylline and some antidepressants and boost insulin absorption, so tell prescribers you quit.
- Used gum, lozenges and even worn patches still hold enough nicotine to harm a child or pet, so wrap and discard them.
Patient information guide A plain-language walkthrough of Nicotine, written from its FDA label.
What Nicotine is used for
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Nicotine replacement products are approved to reduce withdrawal symptoms — including cravings — that happen when you stop smoking. This applies across the full range of supported forms and brands.
- Nicorette 4mg Cinnamon Surge and Nicorette Fruit Chill gum reduce nicotine withdrawal symptoms associated with quitting smoking
- Nicotine Polacrilex gum (multiple brands) reduces nicotine withdrawal symptoms associated with quitting smoking
- Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon gum reduces nicotine withdrawal symptoms associated with quitting smoking
- Equate Nicotine, Basic Care Nicotine, care one nicotine, exchange select nicotine, foster and thrive nicotine, and Good Sense Nicotine lozenges reduce nicotine withdrawal symptoms associated with quitting smoking
- Nicotrol nasal spray reduces nicotine withdrawal symptoms associated with quitting smoking
How Nicotine works
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Nicotine binds to nicotinic-cholinergic receptors — nerve receptors that normally respond to the chemical acetylcholine — in the brain, adrenal glands, and other tissues. This triggers the release of several brain chemicals, including dopamine and norepinephrine, which create mild stimulating and rewarding feelings. By delivering a controlled, lower amount of nicotine than cigarettes do, replacement products ease the discomfort of withdrawal without the toxic chemicals in tobacco smoke.
At low doses, nicotine's stimulating effects are most noticeable. At higher doses, the calming, reward-related effects become more prominent. The body does build tolerance to some of nicotine's effects over time, which is why the 12-week tapering approach gradually reduces how much you use.
Nicotine dosage
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Nicotine replacement products are started on your planned quit day and used on a structured 12-week schedule that gradually reduces frequency. The strength you use may depend on when you smoke your first cigarette of the day — those who smoke within 30 minutes of waking typically need a higher strength.
- Gum: Chewed slowly using the "chew and park" technique — chew until a tingle, rest it in your cheek, repeat — for about 30 minutes per piece. Avoid food and drink for 15 minutes before use.
- Lozenges: Allowed to dissolve slowly in the mouth for 20–30 minutes. Do not chew or swallow. Avoid food and drink for 15 minutes before and during use.
- Nicotrol nasal spray: Used as directed by a prescriber, sprayed into each nostril. Frequency is tapered over time.
Always follow the full instructions included with your specific product and consult your prescriber or pharmacist with any questions.
Dosing details from the FDA-approved label
From the Nicotine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Nicotine lozenge, 2 mg (for smokers whose first cigarette is more than 30 minutes after waking up)
- Begin on quit day. 12 week schedule: Weeks 1 to 6: 1 lozenge every 1 to 2 hours
- Weeks 7 to 9: 1 lozenge every 2 to 4 hours
- Weeks 10 to 12: 1 lozenge every 4 to 8 hours
- Use at least 9 lozenges per day for the first 6 weeks
- Let the lozenge slowly dissolve (about 20-30 minutes)
- Do not chew or swallow
- Maximum: Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
- If under 18 years of age, ask a doctor before use
- Nicotine lozenge, 4 mg (for smokers whose first cigarette is within 30 minutes of waking up)
- Begin on quit day. 12 week schedule: Weeks 1 to 6: 1 lozenge every 1 to 2 hours
- Weeks 7 to 9: 1 lozenge every 2 to 4 hours
- Weeks 10 to 12: 1 lozenge every 4 to 8 hours
- Use at least 9 lozenges per day for the first 6 weeks
- Let the lozenge slowly dissolve (about 20-30 minutes)
- Do not chew or swallow
- Maximum: Do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
- If under 18 years of age, ask a doctor before use
- Nicotine gum, 2 mg (for smokers whose first cigarette is more than 30 minutes after waking up)
- Begin on quit day. 12 week schedule: Weeks 1 to 6: 1 piece every 1 to 2 hours
- Weeks 7 to 9: 1 piece every 2 to 4 hours
- Weeks 10 to 12: 1 piece every 4 to 8 hours
- Use at least 9 pieces per day for the first 6 weeks
- With strong or frequent cravings, may use a second piece within the hour
- Chew slowly until it tingles, then park it between cheek and gum
- Re
- Maximum: Do not use more than 24 pieces a day
- If under 18 years of age, ask a doctor before use
- Nicotine gum, 4 mg (for smokers whose first cigarette is within 30 minutes of waking up)
- Begin on quit day. 12 week schedule: Weeks 1 to 6: 1 piece every 1 to 2 hours
- Weeks 7 to 9: 1 piece every 2 to 4 hours
- Weeks 10 to 12: 1 piece every 4 to 8 hours
- Use at least 9 pieces per day for the first 6 weeks
- With strong or frequent cravings, may use a second piece within the hour
- Chew slowly until it tingles, then park it between cheek and gum
- Re
- Maximum: Do not use more than 24 pieces a day
- If under 18 years of age, ask a doctor before use
Read the label’s full dosing text
Directions • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours • nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider. Other information • store at 20-25˚C (68-77˚F) • keep vial tightly closed and protect from light
Read the full Dosage and Administration section on DailyMed →
Nicotine side effects
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Side effects vary by the form of nicotine replacement used.
Common side effects
- Nasal irritation, runny nose, or sneezing (especially with Nicotrol nasal spray)
- Nausea or upset stomach
- Headache
- Hiccups or heartburn
- Mouth or throat irritation
- Dizziness
- Coughing or watery eyes
- Trouble sleeping
- Jaw soreness (with gum, from chewing technique)
When to get medical help
- Get medical help right away if you have symptoms of nicotine overdose: nausea, vomiting, dizziness, diarrhea, weakness, or rapid heartbeat
- Stop use and call a doctor if you develop an irregular heartbeat or palpitations
- Stop use and call a doctor if you have signs of an allergic reaction, such as difficulty breathing or a rash
- Stop use and call a doctor if mouth, teeth, or jaw problems occur
- Call Poison Control (1-800-222-1222) immediately if a child or pet is exposed to any nicotine product
Nicotine warnings and precautions
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- Heart conditions: Nicotine raises heart rate and blood pressure. People with heart disease, a recent heart attack, irregular heartbeat, or uncontrolled high blood pressure should consult a doctor before use.
- Pregnancy and breastfeeding: Only use nicotine replacement during pregnancy or while breastfeeding on a doctor's advice. Quitting smoking is the safest option; the risks of nicotine replacement to the baby are not fully understood.
- Children and pets: Keep all nicotine products out of reach. Even a small amount can cause serious harm to a child or pet. Dispose of used lozenges or gum safely by wrapping in paper and discarding in the trash.
- Other medical conditions: Check with a doctor before use if you have a stomach ulcer, diabetes, a history of seizures, or are on a sodium-restricted diet.
- Medicines: Tell your doctor or pharmacist about all prescriptions — especially for depression or asthma — since quitting smoking can change how your body processes several medications.
Nicotine interactions
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Quitting smoking — with or without nicotine replacement — changes how your body handles several medications, so some doses may need to be adjusted.
- Acetaminophen, caffeine, theophylline, some antidepressants (e.g., imipramine): Blood levels may rise when you quit smoking; lower doses may be needed
- Insulin: Absorption under the skin improves after quitting; blood sugar should be monitored more closely
- Beta-blockers (e.g., propranolol) and alpha-blockers (e.g., prazosin, labetalol): May become stronger after quitting; dose reductions may be needed
- Adrenergic agonists (e.g., isoproterenol, phenylephrine): May become less effective after quitting; doses may need to increase
- Nasal decongestants (e.g., xylometazoline): When used with Nicotrol nasal spray, these can delay how quickly nicotine is absorbed
- Colds and nasal congestion: Can reduce the amount of nicotine absorbed from Nicotrol nasal spray
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Nicotine
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- Tell your doctor if you have heart disease, a recent heart attack, or irregular heartbeat
- Tell your doctor if you have high blood pressure not well-controlled by medication
- Tell your doctor if you have a stomach ulcer, diabetes, or a history of seizures
- Tell your doctor if you follow a sodium-restricted diet
- Tell your doctor or pharmacist if you take any prescription medications, especially for depression or asthma
- Do not use if you are allergic to nicotine or any ingredient in the product
- Pregnant or breastfeeding? Use only under a doctor's guidance — quitting without medication is preferred if possible
- Under age 18? Ask a doctor before use; no studies confirm effectiveness in this age group
Nicotine overdose
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Signs of too much nicotine include nausea, abdominal pain, vomiting, diarrhea, sweating, flushing, dizziness, confusion, weakness, palpitations (feeling your heart racing or fluttering), and low blood pressure. If you or someone else takes too much, call Poison Control right away at 1-800-222-1222 or seek emergency medical help immediately. Keep all nicotine products away from children and pets, as even small amounts can be dangerous.
What Nicotine does in the body
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Nicotine causes the blood vessels near the skin to narrow (peripheral vasoconstriction), raises heart rate (tachycardia), and increases blood pressure. Both the body and brain develop tolerance to some of these effects — meaning the same amount produces a weaker response over time — though tolerance does not develop to nicotine's ability to raise stress hormones (catecholamines). Nicotine withdrawal causes a distinct set of symptoms including irritability, anxiety, difficulty concentrating, increased appetite, and weight gain; nicotine replacement helps reduce these by maintaining lower but steady nicotine levels in the blood.
How your body processes Nicotine
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When Nicotrol nasal spray is used, nicotine is absorbed quickly through the nasal lining — about half the dose reaches the bloodstream, with peak blood levels appearing within about 4 to 15 minutes. The apparent absorption half-life (the time for half the nicotine to be absorbed) is approximately 3 minutes for the nasal spray, making it one of the faster-acting delivery methods. Blood levels vary widely between individuals; about 1 in 5 people using a standard dose reach levels similar to smoking one cigarette.
How to store Nicotine
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store at 20 - 25°C (68 - 77°F) protect from light
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Nicotine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Nicotine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
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How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
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I tried the gum before and it made me feel sick — am I using it wrong?
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Can I use this if I have heart problems or high blood pressure?
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Is it safe to use nicotine replacement if I'm pregnant?
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What should I do if I accidentally take too much or a child gets into the product?
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Is Nicotine available over the counter?
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When was Nicotine first available?
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Who makes Nicotine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Nicotine on HelloPharmacist
Nicotine forms and strengths (how it comes)
Nicotine is available in 8 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Nicotine inactive ingredients by manufacturer.
Lozenge
How this form is used
- Equate Nicotine lozenge reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Basic Care Nicotine lozenge reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- care one nicotine lozenge reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- foster and thrive nicotine lozenge reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Place the lozenge in your mouth and let it dissolve slowly — about 20 to 30 minutes; do not chew or swallow it
- Occasionally move the lozenge from one side of your mouth to the other while it dissolves
- Do not eat or drink for 15 minutes before using or while the lozenge is in your mouth
- Follow the 12-week tapering schedule: more frequent use early on, then gradually spacing out doses
Chewing gum
How this form is used
- Nicorette gum reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon gum reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Chew slowly until you feel a tingle, then park the gum between your cheek and gum; repeat until the tingle fades — about 30 minutes per piece
- Do not eat or drink for 15 minutes before chewing nicotine gum
- Begin using on your quit day and follow the 12-week tapering schedule
- If you smoke your first cigarette within 30 minutes of waking, use the higher-strength gum; if later, use the lower-strength gum
Skin patch
Show 16 more strengths Show fewer strengths
Buccal tablet
How this form is used
- Nicorette 4mg Cinnamon Surge reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Nicotine Polacrilex (buccal) reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Begin using on your quit day
- Use the strength that matches when you smoke your first cigarette of the day — earlier smokers typically need the higher strength
- Follow the 12-week tapering schedule included with your product, gradually reducing how often you use it
- Do not eat or drink for 15 minutes before use
Oral solution
Nasal spray
How this form is used
- Nicotrol nasal spray reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
- Nicotrol nasal spray is sprayed into each nostril as directed — one dose equals one spray in each nostril
- Nasal irritation is very common when starting Nicotrol, especially in the first few days; it usually becomes milder with continued use
- If you have a cold or nasal congestion, nicotine absorption from Nicotrol may be reduced or delayed
- Follow your prescriber's instructions for how often to use Nicotrol and how to taper off
Spray
Topical cream, ointment or gel
Nicotine on the U.S. market: products, makers and brands
How Nicotine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
84 companies list 755 Nicotine product records with the FDA, mostly as lozenge, chewing gum, skin patch; the earliest marketing or approval year on record is 1984. Brand names on the directory include Thrive, Nicotrol, Nicorette and 13 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (27) · Kit (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Nicotine is used (Medicaid data)
A general measure of how commonly Nicotine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Nicotine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Nicotine prescribed? Of the 1,601 medications we measure, Nicotine ranks #113 by Medicaid prescriptions — more than 93% of them.
Utilization by Nicotine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
24 HR nicotine 0.875 MG/HR Transdermal System Most dispensed
Summed across the 21 of 115 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198030
24 HR nicotine 0.583 MG/HR Transdermal System
Summed across the 14 of 82 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198029
nicotine 4 MG Chewing Gum
Summed across the 34 of 417 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311975
24 HR nicotine 0.292 MG/HR Transdermal System
Summed across the 14 of 74 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198031
nicotine 2 MG Chewing Gum
Summed across the 29 of 401 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314119
nicotine 4 MG Oral Lozenge
Summed across the 20 of 456 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 359818
nicotine 2 MG Oral Lozenge
Summed across the 18 of 451 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 359817
nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797886
Other Nicotine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 344 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nicotine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 153 of 2,341 listed Nicotine NDCs with Medicaid activity.
Compare Nicotine products
A representative set of FDA-listed product records for Nicotine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Buccal tablet | ||||
| 2 mg | Buccal | A-S Medication Solutions | ANDA | View NDC → |
| 2 mg | Buccal | AAFES/Your Military Exchanges × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | View NDC → |
| 4 mg | Buccal | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | ANDA | View NDC → |
| 2 mg | Buccal | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 4 mg | Buccal | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 2 mg | Buccal | Cardinal Health 107, LLC | ANDA | View NDC → |
| 2 mg | Buccal | Cardinal Health 110, Llc. Dba Leader 70000 × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | Chain Drug Consortium, LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | CVS Pharmacy × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 4 mg | Buccal | Fertin Pharma A/S | ANDA | View NDC → |
| 4 mg | Buccal | Lil' Drug Store products, Inc. × 2 listings | NDA | View NDC → |
| 2 mg | Buccal | P & L Development, LLC | ANDA | View NDC → |
| 2 mg | Buccal | Publix Supermarkets, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | Rugby Laboratories × 2 listings | ANDA | View NDC → |
| 2 mg | Buccal | Walgreens × 2 listings | ANDA | View NDC → |
| 💊Chewing gum | ||||
| 2 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 4 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 2 mg | Oral | Amazon.com Services LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | American Sales Company × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Bjwc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Blip Products, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Costco Wholesale Company × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated | ANDA | View NDC → |
| 4 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated | ANDA | View NDC → |
| 4 mg | Oral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Dolgencorp Inc | ANDA | View NDC → |
| 2 mg | Oral | Dr. Reddy's Laboratories Inc. × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Family Dollar (FAMILY WELLNESS) | ANDA | View NDC → |
| 4 mg | Oral | Guangzhou Shuimu Jiahe Trading Co., Ltd. × 2 listings | OTC MONOGRAPH DRUG | View NDC → |
| 2 mg | Oral | Haleon US Holdings LLC × 2 listings | NDA | View NDC → |
| 2 mg | Oral | H E B × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | HyVee Inc | ANDA | View NDC → |
| 4 mg | Oral | HyVee Inc | ANDA | View NDC → |
| 2 mg | Oral | Kroger Company × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | L. Perrigo Company × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Lil' Drug Store Products, Inc. × 2 listings | NDA | View NDC → |
| 2 mg | Oral | Lucy Goods, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | McKesson Corporation dba SKY Packaging | ANDA | View NDC → |
| 4 mg | Oral | McKesson Corporation dba SKY Packaging | ANDA | View NDC → |
| 2 mg | Oral | Meijer, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Meijer Distribution Inc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | P & L Development, LLC | ANDA | View NDC → |
| 4 mg | Oral | P & L Development, LLC | ANDA | View NDC → |
| 2 mg | Oral | Padagis Israel Pharmaceuticals Ltd | ANDA | View NDC → |
| 4 mg | Oral | Padagis Israel Pharmaceuticals Ltd | ANDA | View NDC → |
| 2 mg | Oral | Publix Super Markets Inc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Quitine Llc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Rite Aid Corporation × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Safeway × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Sam's West Inc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Strategic Sourcing Services LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Target Corporation × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | The Kroger Co. | ANDA | View NDC → |
| 4 mg | Oral | The Kroger Co. | ANDA | View NDC → |
| 2 mg | Oral | Topco Associates LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Wal-Mart Stores Inc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Walgreen Company × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Walgreens × 2 listings | ANDA | View NDC → |
| 💊Lozenge | ||||
| 2 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 4 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 2 mg | Oral | Amazon.com Services LLC × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | American Sales Company × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Army & Air Force Exchange Service × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Atlantic Biologicals Corp. | ANDA | View NDC → |
| 2 mg | Oral | Aurohealth LLC | ANDA | View NDC → |
| 2 mg | Oral | Bjwc | ANDA | View NDC → |
| 2 mg | Oral | Blip Products, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 2 mg | Oral | Cardinal Health (Leader) 70000 | ANDA | View NDC → |
| 4 mg | Oral | Chain Drug Consortium, LLC | ANDA | View NDC → |
| 2 mg | Oral | Costco Wholesale Company | ANDA | View NDC → |
| 2 mg | Oral | CVS Pharmacy | ANDA | View NDC → |
| 2 mg | Oral | Cvs Woonsocket Prescription Center, Incorporated | ANDA | View NDC → |
| 4 mg | Oral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ANDA | View NDC → |
| 4 mg | Oral | Dolgencorp, LLC | ANDA | View NDC → |
| 4 mg | Oral | Dolgencorp Inc | ANDA | View NDC → |
| 2 mg | Oral | Dr. Reddy's Laboratories Inc. | ANDA | View NDC → |
| 2 mg | Oral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | View NDC → |
| 2 mg | Oral | Haleon US Holdings LLC | NDA | View NDC → |
| 2 mg | Oral | HC Jones, Inc. | ANDA | View NDC → |
| 2 mg | Oral | H E B | ANDA | View NDC → |
| 2 mg | Oral | HyVee Inc | ANDA | View NDC → |
| 2 mg | Oral | Kroger Company | ANDA | View NDC → |
| 2 mg | Oral | L. Perrigo Company | ANDA | View NDC → |
| 2 mg | Oral | Meijer, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Meijer Distribution Inc | ANDA | View NDC → |
| 4 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2 mg | Oral | P & L Development, LLC | ANDA | View NDC → |
| 2 mg | Oral | Padagis Israel Pharmaceuticals Ltd | ANDA | View NDC → |
| 2 mg | Oral | PLD Acquisitions LLC DBA Avma Pharma Solutions | ANDA | View NDC → |
| 2 mg | Oral | Publix Super Markets Inc | ANDA | View NDC → |
| 2 mg | Oral | Quitine Llc | ANDA | View NDC → |
| 2 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Rite Aid Corporation | ANDA | View NDC → |
| 2 mg | Oral | Rugby Laboratories, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Safeway | ANDA | View NDC → |
| 2 mg | Oral | Sam's West Inc | ANDA | View NDC → |
| 2 mg | Oral | Sixarp, LLC | ANDA | View NDC → |
| 2 mg | Oral | Strategic Sourcing Services LLC | ANDA | View NDC → |
| 2 mg | Oral | Target Corporation | ANDA | View NDC → |
| 2 mg | Oral | Topco Associates LLC | ANDA | View NDC → |
| 2 mg | Oral | Wal-Mart Stores Inc | ANDA | View NDC → |
| 2 mg | Oral | Walgreen Company | ANDA | View NDC → |
| 2 mg | Oral | Walgreens | ANDA | View NDC → |
| 2 mg | Oral | Walmart Inc. | ANDA | View NDC → |
| 2 mg | Oral | WALMART INC. (see also Equate) | ANDA | View NDC → |
| 💊Nasal spray | ||||
| 10 mg/mL | Nasal | Pharmacia & Upjohn Company LLC | NDA | View NDC → |
| 💊Skin patch | ||||
| NICOTINE 7 mg/24h | Transdermal | A-S Medication Solutions | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | AmerisourceBergen Drug Corporation | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Aveva Drug Delivery Systems, Inc. | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Aveva Drug Delivery Systems Inc. | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | BluePoint Laboratories | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Cardinal Health | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Cardinal Health 110, Llc. Dba Leader | NDA | View NDC → |
| NICOTINE 14 mg/24h | Transdermal | Chain Drug Marketing Association INC | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | CVS Pharmacy | NDA | View NDC → |
| NICOTINE 21 mg/24h | Transdermal | Dolgencorp, Llc | NDA | View NDC → |
| 21 mg | Transdermal | Dongkou County Hecheng Network Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Dr. Reddy's Laboratories Inc. | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Golden State Medical Supply, Inc. | NDA | View NDC → |
| 7 mg | Transdermal | Guangxi Keyun E-commerce Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 28 mg | Transdermal | Guangzhou Ouruisi Biotechnology Co., Ltd | OTC MONOGRAPH DRUG | View NDC → |
| 7 mg | Transdermal | Guangzhou Yunzhen Trading Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| NICOTINE 14 mg/24h | Transdermal | H-e-b | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Haleon US Holdings LLC | NDA | View NDC → |
| 21 mg | Topical | Henan Jiugao Cross-border Ecommerce Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 21 mg/g | Topical | Jiashen International Trade Limited | OTC MONOGRAPH DRUG | View NDC → |
| 7 mg | Transdermal | Medline Industries, LP | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Meijer, Inc. | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Quitine LLC | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Rite Aid Corporation | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Rugby Laboratories | ANDA | View NDC → |
| NICOTINE 21 mg/24h | Transdermal | Sam's West Inc | NDA | View NDC → |
| 3 mg/1001 | Topical | Shenzhen Paxi Trading Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 21 mg | Transdermal | Shenzhen Shandian Jingling Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 21 mg/1001 | Topical | Shenzhen TeLaFaErJiaLuo Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| 28 mg/1001 | Topical | Shenzhen Xinxin Yunhai Technology Co., Ltd. | OTC MONOGRAPH DRUG | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Strategic Sourcing Services LLC | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Target Corporation | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | The Kroger Co. | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Topco Associates LLC | NDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Wal-Mart Stores Inc | NDA AUTHORIZED GENERIC | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Walgreens | ANDA | View NDC → |
| NICOTINE 7 mg/24h | Transdermal | Walgreens Company | NDA | View NDC → |
| 7 mg/g | Transdermal | Yitongbada (shenzhen) International Trade Co., Ltd | UNAPPROVED DRUG OTHER | View NDC → |
| 7 mg/7 mg | Transdermal | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | OTC MONOGRAPH DRUG | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 42 mg/42 mg | Topical | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | OTC MONOGRAPH DRUG | View NDC → |
| 💊Kits | ||||
| — | Transdermal | Dr. Reddy's Laboratories Inc. | NDA | View NDC → |
| — | Transdermal | Dr. Reddys Laboratories Inc. | NDA | View NDC → |
| — | Transdermal | Rite Aid Corporation | NDA | View NDC → |
Showing 200 of 755 products — FDA National Drug Code Directory. See every product, package size and price: browse all 755 Nicotine NDCs →
Nicotine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nicotine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nicotine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Nicotine FDA approval history
How Nicotine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Nicotine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Nicotine recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. Lots: Lot #: 56841, Expires: 03/2028 FDA record D-0550-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 7407 6 dose forms · 15 strengths
-
Dose form (SCDF) Chewing Gum RxCUI 154906In current FDA listings -
Dose form (SCDF) Inhalation Solution RxCUI 2108539No current FDA listingClinical drug / strength (SCD) 4 MGRxCUI 250983 -
Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797885In current FDA listingsClinical drug / strength (SCD) 0.5 MG/ACTUATRxCUI 1797886 -
Dose form (SCDF) Oral Lozenge RxCUI 379040In current FDA listings -
Dose form (SCDF) Sublingual Tablet RxCUI 385621No current FDA listingClinical drug / strength (SCD) 2 MGRxCUI 227177 -
Dose form (SCDF) Transdermal System RxCUI 1805957In current FDA listingsClinical drug / strength (SCD) 2 HR nicotine 1.5 MG/HRRxCUI 272872124 HR nicotine 0.292 MG/HRRxCUI 19803124 HR nicotine 0.313 MG/HRRxCUI 104684724 HR nicotine 0.583 MG/HRRxCUI 19802924 HR nicotine 0.625 MG/HRRxCUI 41916824 HR nicotine 0.875 MG/HRRxCUI 19803024 HR nicotine 1.17 MG/HRRxCUI 2707585
Look up RxCUI 7407 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Nicotine supply and shortage status
Whether Nicotine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Nicotine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Lozenge · Oral | 2 mg | $0.347 each | NDC details & price history |
| Lozenge · Oral | 4 mg | $0.344–$0.348 each | NDC details & price history |
| Gum, Chewing · Oral | 4 mg | $0.287 each | NDC details & price history |
| Gum, Chewing · Oral | 2 mg | $0.233 each | NDC details & price history |
| Patch · Transdermal | NICOTINE 21 mg/24h | $1.87 each | NDC details & price history |
| Patch · Transdermal | NICOTINE 7 mg/24h | $1.82 each | NDC details & price history |
| Patch · Transdermal | NICOTINE 14 mg/24h | $1.85 each | NDC details & price history |
| Patch · Transdermal | 21 mg/24h | $1.87 each | NDC details & price history |
| Patch · Transdermal | 14 mg/24h | $1.85 each | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Nicotine brand names
Nicotine is sold under 16 brand names in the FDA directory — Thrive, Nicotrol, Nicorette, Habitrol and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Nicotine: manufacturers and labelers
84 companies list Nicotine products with the FDA. By number of product records, the largest are Amazon.com Services LLC, CVS Pharmacy, Haleon US Holdings LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 60 more on the FDA NDC directory.
Nicotine drug class (RxNorm)
Nicotine belongs to the Cholinergic Nicotinic Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Nicotine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mechanical Servants LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →