Nicorette

Product NDC
0135-8070
11-digit product format
001358070
Labeler code
0135
Product ID
0135-8070_3724f342-04db-e129-e063-6294a90a6c7d
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA022360
Marketing category
NDA
Marketing start
2026-04-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Nicorette
Brand name suffix
Cherry Peppermint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817, 359818, 968849, 968851

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-8070-20NicoretteCherry Peppermint20 in 1 VIALLOZENGE202
0135-8070-20NicoretteCherry Peppermint1 in 1 PACKAGELOZENGE12
0135-8070-81NicoretteCherry Peppermint27 in 1 VIALLOZENGE272
0135-8070-81NicoretteCherry Peppermint3 in 1 PACKAGELOZENGE32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968849Nicorette 2 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG Oral LozengePSN35438b53-2760-bcfe-e063-6394a90a65c02
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD35438b53-2760-bcfe-e063-6394a90a65c02
968851nicotine 4 MG Oral Lozenge [Nicorette]SBD35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG Oral LozengeSCD35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG Oral LozengeSCD35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968849Nicorette 2 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
968851Nicorette 4 MG Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359817nicotine 2 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY35438b53-2760-bcfe-e063-6394a90a65c02
359818nicotine 4 MG TrocheSY35438b53-2760-bcfe-e063-6394a90a65c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-8070-20001358070201 VIAL in 1 PACKAGE (0135-8070-20) / 20 LOZENGE in 1 VIAL1 vial2026-04-01NoNoHistorical
0135-8070-81001358070813 VIAL in 1 PACKAGE (0135-8070-81) / 27 LOZENGE in 1 VIAL3 vial2026-04-01NoNoHistorical