Home NDC 0135-0626-01 NICORETTE
Product NDC 0135-0626
Requested package NDC 0135-0626-01
11-digit product format 001350626
Labeler code 0135
Product ID 0135-0626_36c1b8d5-e876-dc22-e063-6294a90aff3b
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 2019-04-11
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N021330-001 NICORETTE NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 N021330-002 NICORETTE NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31
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 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 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021330-001 NICORETTE EQ 2MG BASE TROCHE/LOZENGE / ORAL RLD 2002-10-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021330-002 NICORETTE EQ 4MG BASE TROCHE/LOZENGE / ORAL RLD, RS 2002-10-31 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base NICORETTE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 4 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0626 NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 6 package rows 20240711_f350e050-2173-43e0-8738-848382ce0700.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.
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 0135-0626-01 00135062601 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINER 1 container 2019-04-11 0000-00-00 No No Current