Home NDC 49035-309 equate nicotine
Product NDC 49035-309
11-digit product format 490350309
Labeler code 49035
Product ID 49035-309_df49cc8e-01f1-4d6b-83e0-2173a0567f5c
Type HUMAN OTC DRUG
Nonproprietary name nicotine polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA206393
Marketing category ANDA
Marketing start 2020-03-25
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206393-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15
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 2 · 41 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 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206393-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2016-12-15 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base equate nicotine
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311975 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49035-309-78 equate nicotine 100 in 1 CARTON GUM, CHEWING 100 4 49035-309-78 equate nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-309 EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 4 Current NDC, Legacy NDC, 2 package rows 20250523_bfa8273c-5af8-4074-b6d4-a99a0d0ff712.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 3 · 46 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 49035-309-78 49035030978 100 BLISTER PACK in 1 CARTON (49035-309-78) / 1 GUM, CHEWING in 1 BLISTER PACK 100 blister pack 2020-03-25 0000-00-00 No No Current