Home NDC 41250-029 nicotine
Product NDC 41250-029
11-digit product format 412500029
Labeler code 41250
Product ID 41250-029_36362e3e-34dc-49b4-a126-91f29a204b5b
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Meijer Distribution Inc
Application ANDA076775
Marketing category ANDA
Marketing start 2005-02-06
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 42 .
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 A076775-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076775-001 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 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 e64feba35796…
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 41250-029-25 nicotine 110 in 1 CARTON GUM, CHEWING 110 8 41250-029-25 nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 41250-029-29 nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 41250-029-29 nicotine 220 in 1 CARTON GUM, CHEWING 220 8 41250-029-96 nicotine 170 in 1 CARTON GUM, CHEWING 170 8 41250-029-96 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 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 NICOTINE ACTIVE MOIETY 6M3C89ZY6R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-029 NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC] 7 Current NDC, Legacy NDC, 6 package rows 20250328_db0d922a-407f-49ac-b5d3-acc7112a373e.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 · 15 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 41250-029-25 41250002925 110 in 1 CARTON Historical 41250-029-29 41250002929 220 BLISTER PACK in 1 CARTON (41250-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK 220 blister pack 2019-04-24 0000-00-00 No No Current 41250-029-96 41250002996 170 BLISTER PACK in 1 CARTON (41250-029-96) / 1 GUM, CHEWING in 1 BLISTER PACK 170 blister pack 2005-02-06 0000-00-00 No No Current