NICORETTE

Manufacturer
Carilion Materials Management
Effective date
2018-02-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:54:24

Label at a glance#

ProductNICORETTE
Active ingredientNICOTINE
Label structure12 sections

Dosage and administration

• 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 cigarett...

Label contents#

Full prescribing information#

Active ingredient (in each lozenge)(2mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge)(4mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 4 mg

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

WARNINGS SECTION

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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 are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • mouth problems occur
  • persistent indigestion or severe sore throat 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions (2mg Lozenge)

DOSAGE & ADMINISTRATION SECTION

  • 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 1to 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.

Directions (4mg Lozenge)

DOSAGE & ADMINISTRATION SECTION

  • 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 1to 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

SPL UNCLASSIFIED SECTION

  • each lozenge contains: sodium, 5 mg
  • store at 20 – 25oC (68 – 77oF)
  • keep vial tightly closed and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, calcium polycarbophil, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-569-1743

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 68151-5980

NDC: 68151-5980-1 1 LOZENGE in a BLISTER PACK

NICORETTE (NICOTINE POLACRILEX) LOZENGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
968849Nicorette 2 MG Oral LozengePSN4
359817nicotine 2 MG Oral LozengePSN4
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD4
359817nicotine 2 MG Oral LozengeSCD4
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY4
968849Nicorette 2 MG Oral LozengeSY4
968849Nicorette 2 MG TrocheSY4
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY4
359817nicotine 2 MG TrocheSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-5980-12020-01-31C16284748780-19d75b9d0-106f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5980-1NICORETTE1 in 1 BLISTER PACKLOZENGE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5980NICORETTE (NICOTINE POLACRILEX) LOZENGE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20180207_e5f70dda-dd7a-49d4-992f-fb28b4bf0efc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0508-02EA - Each0135-05084cfc8acc-c2c6-4aee-a9b5-21a75902554e12012-07-24
0135-0508-03EA - Each0135-05084f481875-bff3-4635-bf3b-5199434b230512012-07-24
0135-0508-04EA - Each0135-05082108ac5f-c1cc-41bf-8f4d-5e7a53ad071b12017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68151-598068151-5980-1
0135-0508

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022360-001NICORETTENICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18
N022360-002NICORETTENICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022360-00189407722029-04-30Drug product2015-02-25
N022360-00185011642029-06-14Drug product2013-09-05
N022360-00289407722029-04-30Drug product2015-02-25
N022360-00285011642029-06-14Drug product2013-09-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1884e616aacf4f…
2026-09-14 22:38:342026-08N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1884e616aacf4f…
2026-08-18 06:07:402026-07N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022360-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2009-05-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022360-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2009-05-1874a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022360-00189407722029-04-30Drug product2015-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N022360-00185011642029-06-14Drug product2013-09-0584e616aacf4f…
2026-09-14 22:38:342026-08N022360-00289407722029-04-30Drug product2015-02-2584e616aacf4f…
2026-09-14 22:38:342026-08N022360-00285011642029-06-14Drug product2013-09-0584e616aacf4f…
2026-08-18 06:07:402026-07N022360-00189407722029-04-30Drug product2015-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022360-00185011642029-06-14Drug product2013-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022360-00289407722029-04-30Drug product2015-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022360-00285011642029-06-14Drug product2013-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022360-00189407722029-04-30Drug product2015-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00185011642029-06-14Drug product2013-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00289407722029-04-30Drug product2015-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022360-00285011642029-06-14Drug product2013-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00189407722029-04-30Drug product2015-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00185011642029-06-14Drug product2013-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00289407722029-04-30Drug product2015-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022360-00285011642029-06-14Drug product2013-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022360-00189407722029-04-30Drug product2015-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00185011642029-06-14Drug product2013-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00289407722029-04-30Drug product2015-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022360-00285011642029-06-14Drug product2013-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00189407722029-04-30Drug product2015-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00185011642029-06-14Drug product2013-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00289407722029-04-30Drug product2015-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022360-00285011642029-06-14Drug product2013-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00189407722029-04-30Drug product2015-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00185011642029-06-14Drug product2013-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00289407722029-04-30Drug product2015-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022360-00285011642029-06-14Drug product2013-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00189407722029-04-30Drug product2015-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00185011642029-06-14Drug product2013-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00289407722029-04-30Drug product2015-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022360-00285011642029-06-14Drug product2013-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00189407722029-04-30Drug product2015-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00185011642029-06-14Drug product2013-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00289407722029-04-30Drug product2015-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022360-00285011642029-06-14Drug product2013-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00189407722029-04-30Drug product2015-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00185011642029-06-14Drug product2013-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00289407722029-04-30Drug product2015-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022360-00285011642029-06-14Drug product2013-09-055bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCfdee1637-8049-4bc5-b196-b6d854c9f9f32024-03-05WarningsExact identifier
ndc (product): 0135-0508
62c04eb3-1970-4f9e-a94d-4e8fecbd0bd9e5f70dda-dd7a-49d4-992f-fb28b4bf0efc2018-02-06WarningsExact identifier
spl id: 62c04eb3-1970-4f9e-a94d-4e8fecbd0bd9
spl set id: e5f70dda-dd7a-49d4-992f-fb28b4bf0efc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.