Home NDC 50090-8146 Nicotine Polacrilex
Product NDC 50090-8146
11-digit product format 500908146
Labeler code 50090
Product ID 50090-8146_739217a2-97f4-401e-bf5a-2812c1e7c32b
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078697
Marketing category ANDA
Marketing start 2023-08-10
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078697-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29
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 · 44 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 2026-10-15 13:18:30 2026-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078697-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2008-12-29 3a93d1ddd44b…
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 Polacrilex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 4 mg/1
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 · 13 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8146-0 50090814600 110 BLISTER PACK in 1 CARTON (50090-8146-0) / 1 GUM, CHEWING in 1 BLISTER PACK 110 blister pack 2026-10-12 No No Current