Home NDC 49035-422 equate nicotine
Product NDC 49035-422
11-digit product format 490350422
Labeler code 49035
Product ID 49035-422_e87b40ed-0d7b-4c5e-986f-42e78595a521
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA078326
Marketing category ANDA
Marketing start 2005-03-08
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 A078326-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30
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 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base equate nicotine
Listing expiration 2027-12-31 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 49035-422-20 equate nicotine 200 in 1 CARTON GUM, CHEWING 200 8 49035-422-20 equate nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 49035-422-96 equate nicotine 170 in 1 CARTON GUM, CHEWING 170 8 49035-422-96 equate nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 NICOTINE ACTIVE MOIETY 6M3C89ZY6R EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-422 EQUATE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WAL-MART STORES INC] 7 Current NDC, Legacy NDC, 4 package rows 20241022_768e3f3d-d867-4574-8a5d-07572e2e4a04.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 49035-422-20 49035042220 200 BLISTER PACK in 1 CARTON (49035-422-20) / 1 GUM, CHEWING in 1 BLISTER PACK 200 blister pack 2025-08-22 No No Current 49035-422-96 49035042296 170 BLISTER PACK in 1 CARTON (49035-422-96) / 1 GUM, CHEWING in 1 BLISTER PACK 170 blister pack 2005-04-06 0000-00-00 No No Current