Home NDC 0135-0508 NICORETTE
Product NDC 0135-0508
11-digit product format 001350508
Labeler code 0135
Product ID 0135-0508_12f1fec8-003a-8788-e063-6394a90a298a
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 2010-03-01
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0135-0508-02 excluded package package 0135-0508-04 excluded package package 0135-0508-03
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022360-001 NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 N022360-002 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022360-001 8940772 2029-04-30 Drug product 2015-02-25 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 N022360-002 8501164 2029-06-14 Drug product 2013-09-05
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022360-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2009-05-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022360-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2009-05-18 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022360-001 8940772 2029-04-30 Drug product 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022360-001 8501164 2029-06-14 Drug product 2013-09-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022360-002 8940772 2029-04-30 Drug product 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022360-002 8501164 2029-06-14 Drug product 2013-09-05 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base NICORETTE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359817 Internal RxNorm lookup 359818 Internal RxNorm lookup 968849 Internal RxNorm lookup 968851 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0508 NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC] 15 Current NDC, Legacy NDC, 5 package rows 20240307_fdee1637-8049-4bc5-b196-b6d854c9f9f3.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0135-0508-02 00135050802 3 CONTAINER in 1 CARTON (0135-0508-02) / 27 LOZENGE in 1 CONTAINER 3 container 2010-03-01 0000-00-00 No No Current 0135-0508-03 00135050803 5 CONTAINER in 1 CARTON (0135-0508-03) / 27 LOZENGE in 1 CONTAINER 5 container 2010-03-01 0000-00-00 No No Current 0135-0508-04 00135050804 20 LOZENGE in 1 CONTAINER (0135-0508-04) 20 lozenge 2010-03-01 0000-00-00 No No Current