Home NDC 0363-1012 nicotine
Product NDC 0363-1012
11-digit product format 003631012
Labeler code 0363
Product ID 0363-1012_f0cba5af-3e27-4aa0-ba5d-d2db526e4d3f
Type HUMAN OTC DRUG
Nonproprietary name Nicotine polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Walgreen Company
Application ANDA206394
Marketing category ANDA
Marketing start 2018-02-02
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A206394-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG 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 · 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 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206394-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2016-12-15 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 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 314119 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 0363-1012-06 nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 6 0363-1012-06 nicotine 160 in 1 CARTON GUM, CHEWING 160 6 0363-1012-76 nicotine 120 in 1 CARTON GUM, CHEWING 120 6 0363-1012-76 nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 6 0363-1012-78 nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 6 0363-1012-78 nicotine 100 in 1 CARTON GUM, CHEWING 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1012 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY] 5 Current NDC, Legacy NDC, 6 package rows 20250427_a1258f0a-24d2-40b0-8f44-06f2cafd7d26.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 2 of 3 · 44 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 0363-1012-06 00363101206 160 BLISTER PACK in 1 CARTON (0363-1012-06) > 1 GUM, CHEWING in 1 BLISTER PACK 160 blister pack 2018-02-05 0000-00-00 No No Current 0363-1012-76 00363101276 120 BLISTER PACK in 1 CARTON (0363-1012-76) > 1 GUM, CHEWING in 1 BLISTER PACK 120 blister pack 2018-02-05 0000-00-00 No No Current 0363-1012-78 00363101278 100 BLISTER PACK in 1 CARTON (0363-1012-78) / 1 GUM, CHEWING in 1 BLISTER PACK 100 blister pack 2018-02-02 0000-00-00 No No Current