Home NDC 49035-998 Equate Nicotine
Product NDC 49035-998
11-digit product format 490350998
Labeler code 49035
Product ID 49035-998_0cbc7c2c-06e2-4e3e-9d48-bcfb0fb602d3
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form LOZENGE
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA077007
Marketing category ANDA
Marketing start 2006-12-15
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49035-998-10 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49035-998-11 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49035-998-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49035-998-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49035-998-10 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49035-998-11 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49035-998-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49035-998-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49035-998-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49035-998-11 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49035-998-03 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49035-998-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49035-998-11 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49035-998-09 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49035-998-11 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49035-998-09 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49035-998-11 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49035-998-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
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 A077007-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 A077007-002 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31
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 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077007-001 NICOTINE POLACRILEX EQ 2MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077007-002 NICOTINE POLACRILEX EQ 4MG BASE TROCHE/LOZENGE / ORAL 2006-01-31 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Equate Nicotine
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359817 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 49035-998 EQUATE NICOTINE (NICOTINE POLACRILEX) LOZENGE [WAL-MART STORES INC] 10 Current NDC, Legacy NDC, 6 package rows 20250205_19fad004-2997-4169-939a-dc525dc9e6cc.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 4 · 75 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 49035-998-03 49035099803 1 CONTAINER in 1 CARTON (49035-998-03) / 24 LOZENGE in 1 CONTAINER 1 container 2011-10-07 0000-00-00 No No Current 49035-998-09 49035099809 27 in 1 CONTAINER Historical 49035-998-10 49035099810 4 CONTAINER in 1 CARTON (49035-998-10) / 27 LOZENGE in 1 CONTAINER (49035-998-09) 4 container 2010-03-24 0000-00-00 No No Current 49035-998-11 49035099811 7 CONTAINER in 1 CARTON (49035-998-11) / 24 LOZENGE in 1 CONTAINER 7 container 2020-04-17 0000-00-00 No No Current