Home NDC 41250-456 Nicotine
Product NDC 41250-456
11-digit product format 412500456
Labeler code 41250
Product ID 41250-456_d06119b1-1c60-4a98-9f45-64c5f3e7314a
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA076777
Marketing category ANDA
Marketing start 2006-10-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A076777-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16
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 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076777-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 cb3db0bc1861…
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 41250-456-06 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 41250-456-06 Nicotine 160 in 1 CARTON GUM, CHEWING 160 10 41250-456-58 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 41250-456-58 Nicotine 40 in 1 CARTON GUM, CHEWING 40 10 41250-456-60 Nicotine 20 in 1 CARTON GUM, CHEWING 20 10 41250-456-60 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 41250-456-70 Nicotine 240 in 1 CARTON GUM, CHEWING 240 10 41250-456-70 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 41250-456-76 Nicotine 120 in 1 CARTON GUM, CHEWING 120 10 41250-456-76 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 41250-456-78 Nicotine 100 in 1 CARTON GUM, CHEWING 100 10 41250-456-78 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 NICOTINE ACTIVE MOIETY 6M3C89ZY6R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-456 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 9 Current NDC, Legacy NDC, 12 package rows 20250305_6d86cb8f-018e-41be-a6d0-9ca30e731855.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 · 11 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 41250-456-06 41250045606 160 BLISTER PACK in 1 CARTON (41250-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK 160 blister pack 2007-05-04 0000-00-00 No No Current 41250-456-58 41250045658 1 in 1 BLISTER PACK Historical 41250-456-60 41250045660 20 BLISTER PACK in 1 CARTON (41250-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK 20 blister pack 2014-06-20 0000-00-00 No No Current 41250-456-70 41250045670 240 BLISTER PACK in 1 CARTON (41250-456-70) / 1 GUM, CHEWING in 1 BLISTER PACK 240 blister pack 2011-06-03 0000-00-00 No No Current 41250-456-76 41250045676 120 BLISTER PACK in 1 CARTON (41250-456-76) / 1 GUM, CHEWING in 1 BLISTER PACK 120 blister pack 2007-11-07 0000-00-00 No No Current 41250-456-78 41250045678 100 BLISTER PACK in 1 CARTON (41250-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK 100 blister pack 2006-10-31 0000-00-00 No No Current