Habitrol Nicotine Polacrilex Lozenge Mint Nicotine Polacrilex Lozenge 4 mg 4 mg Lozenge, 27-count — NDC 43598-987-27 (Billing 43598-0987-27)
This is a package of 27 lozenges of Habitrol Nicotine Polacrilex Lozenge Mint Nicotine Polacrilex Lozenge 4 mg 4 mg Lozenge from Dr. Reddy's Laboratories Inc., marketed since May 2021 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 43598-987-27 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 43598 labeler · 987 product · 27 package
- Package marketed since
- May 21, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 4359898727 9
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 359817
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Nicotinic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- That's a really common concern, and it's worth addressing. Nicotine replacement products do deliver nicotine, but in a much more controlled way — without the tar, carbon monoxide,...
- What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
- Yes, it actually does matter. If you typically smoke your first cigarette within 30 minutes of waking up, your nicotine dependence is likely stronger, so you'd use the higher-stren...
- How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 43598-0987-13 43598-987-13 Main listing | 5 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE | 2021-05-21 | — | Active |
| 43598-0987-24 43598-987-24 | 1 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE | 2021-05-21 | — | Active |
| 43598-0987-27 You're viewing this | 1 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE | 2021-05-21 | — | Active |
| 43598-0987-72 43598-987-72 | 3 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE | 2021-05-21 | — | Active |
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 43598-0987-24?
What NDC number is used to bill for this package of Habitrol Nicotine Polacrilex Lozenge Mint Nicotine Polacrilex Lozenge 4 mg 4 mg Lozenge?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nicotine Polacrilex Lozenge Mint 4 mg 63868-0732-24 | Chain | 24 lozenges | — | — | Discontinued | — |
| Habitrol Nicotine Polacrilex Lozenge Mint 4 mgthis 43598-0987-27 | Dr. | 27 lozenges | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Nicotine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 1AEY1M553N
A natural oil extracted from spearmint or field mint leaves, used as a flavoring agent to give medicines a minty taste and aroma. It may also provide a cooling sensation in topical products.
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UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
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UNII AV092KU4JH
A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
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UNII RCZ785HI7S
A synthetic polymer made from acrylic acid that absorbs moisture. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active drug can be released and absorbed.
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UNII HM5Z15LEBN
Potassium bicarbonate is a salt that acts as a buffer and pH regulator in medicines. It helps maintain a stable acid-alkaline balance so the drug stays effective and doesn't irritate the stomach or mouth.
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UNII C269C4G2ZQ
Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
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UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Dr. Reddy's Laboratories Inc. labeler code 43598
- Rivaroxaban 2.5 mg Tablet NDC 43598-981-18
- Habitrol Lozenge Original Flavor Nicotine Polacrilex 2 mg Lozenge NDC 43598-982-13
- Habitrol Lozenge Original Flavor Nicotine Polacrilex 4 mg Lozenge NDC 43598-983-13
- Habitrol Lozenge Cherry Nicotine Polacrilex 2 mg Lozenge NDC 43598-984-13
- Habitrol Lozenge Cherry Nicotine Polacrilex 4 mg Lozenge NDC 43598-985-13
- Habitrol Nicotine Polacrilex Lozenge Mint Nicotine Polacrilex Lozenge 2 mg 2 mg Lozenge NDC 43598-986-13
- venlafaxine hydrochloride 37.5 mg Capsule, Extended Release NDC 43598-999-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
⏱️ Dosage and Administration ▾
Directions 2 mg : 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 (about 20-30 minutes).
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 (about 20-30 minutes) 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 leat 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time of 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. 4 mg : 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 more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 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 (about 20-30 minutes).
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 (about 20-30 minutes) 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 of 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.
⚠️ Warnings ▾
Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.
This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do not use if you are allergic to soya Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat.
Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you have using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
Stop use and ask doctor if mouth problems occur persistent indigestion or severe sore that occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children and pets Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash.
In case of overdose, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredients (in each lozenge) Nicotine polacrilex, 2 mg Nicotine polacrilex, 4 mg
🧪 Inactive Ingredients ▾
Inactive ingredients Acacia, corn mint oil, flavors, magnesium stearate, mannitol, menthol, peppermint oil, potassium bicarbonate, sodium alginate, sodium carbonate anhydrous, sucralose, triacetin and xanthan gum.
🎯 Purpose ▾
Purpose Stop smoking aid
📄 Do Not Use ▾
Do not use if you are allergic to soya
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes history of seizures
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you have using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask doctor if mouth problems occur persistent indigestion or severe sore that occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)
📄 Keep Out of Reach of Children ▾
Keep out of reach of children and pets Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? c all toll-free 1-800-585-8682 weekdays (8:00 am to 10:00 pm ET)
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Habitrol Nicotine Polacrilex Lozenge, 2 mg Mint- Container
Principal Display Panel Habitrol Nicotine Polacrilex Lozenge, 2 mg Mint- Carton
Principal Display Panel Habitrol Nicotine Polacrilex Lozenge, 4 mg Mint- Container
Principal Display Panel Habitrol Nicotine Polacrilex Lozenge, 4 mg mint- Carton
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |