NICORETTE

Product NDC
0135-0510
Requested package NDC
0135-0510-01
11-digit product format
001350510
Labeler code
0135
Product ID
0135-0510_142b2250-8264-423f-e063-6394a90ab05b
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021330
Marketing category
NDA
Marketing start
2010-10-19
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-05100135-0510-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021330-001NICORETTENICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31
N021330-002NICORETTENICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31782e0a99824c…
2021-12-28 21:50 UTC2021-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
NICORETTE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359817Internal RxNorm lookup
359818Internal RxNorm lookup
968849Internal RxNorm lookup
968851Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
991704ed-781a-489b-8b56-0b558e8fc385Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0510-012020-11-16Drug Facts
0135-0510-062020-11-16Drug Facts
0135-0510-072020-11-16Drug Facts
0135-0510-012020-01-31Drug Facts
0135-0510-062020-01-31Drug Facts
0135-0510-072020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0510-01NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-01NICORETTE3 in 1 CARTONLOZENGE320
0135-0510-06NICORETTE1 in 1 CARTONLOZENGE120
0135-0510-06NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-07NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-07NICORETTE6 in 1 CARTONLOZENGE620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0510-01EA - Each0135-0510f0ffc1c3-e692-4905-aa88-2faaadb4753112012-07-24
0135-0510-02EA - Each0135-05109ee598da-64eb-4003-8a5c-0d14031d685112012-07-24
0135-0510-03EA - Each0135-051054781fa4-261f-4ce0-a75f-73ff3363547312014-05-02
0135-0510-05EA - Each0135-05105be5cc82-ba49-45eb-898e-05ba8dfcad3312012-07-24
0135-0510-06EA - Each0135-05106b500f22-c3c2-40fb-af1c-142d8b79420d12016-06-14
0135-0510-07EA - Each0135-05104a75b975-1405-40dc-883f-9d90afcdeb0f12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
EUGENOLINACTIVE INGREDIENT3T8H1794QWNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0510NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 6 package rows20240322_991704ed-781a-489b-8b56-0b558e8fc385.zip

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 LLCf350e050-2173-43e0-8738-848382ce07002025-06-04WarningsExact identifier
application applno (NDA): 021330
application number: NDA021330
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLC991704ed-781a-489b-8b56-0b558e8fc3852024-03-21WarningsExact identifier
application applno (NDA): 021330
application number: NDA021330
ndc (package): 0135-0510-01
ndc (product): 0135-0510
ndc11 (package): 00135051001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968849Nicorette 2 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD991704ed-781a-489b-8b56-0b558e8fc38520
968851nicotine 4 MG Oral Lozenge [Nicorette]SBD991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG Oral LozengeSCD991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG Oral LozengeSCD991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0510-01001350510013 CONTAINER in 1 CARTON (0135-0510-01) / 24 LOZENGE in 1 CONTAINER3 container2010-10-190000-00-00NoNoCurrent