Home NDC 0363-0365-78 Nicotine
Product NDC 0363-0365
Requested package NDC 0363-0365-78
11-digit product format 003630365
Labeler code 0363
Product ID 0363-0365_3f364d1d-07d0-4b85-bda1-bc5edcac2652
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Walgreen Company
Application ANDA091349
Marketing category ANDA
Marketing start 2013-03-22
Marketing end 0000-00-00
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-0365 0363-0365-78 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-0365 0363-0365-78 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091349-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20
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 · 43 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 2026-09-14 22:38:34 2026-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091349-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2011-07-20 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 NICOTINE ACTIVE MOIETY 6M3C89ZY6R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 ACACIA INACTIVE INGREDIENT 5C5403N26O NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 MALTITOL INACTIVE INGREDIENT D65DG142WK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0365 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 9 Legacy NDC 20221020_9adf55d6-330b-4828-bab3-befad8c950ef.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0365-78 00363036578 100 BLISTER PACK in 1 CARTON (0363-0365-78) > 1 GUM, CHEWING in 1 BLISTER PACK 100 blister pack 2013-06-07 0000-00-00 No No Current