Home NDC 68196-029 members mark nicotine
Product NDC 68196-029
11-digit product format 681960029
Labeler code 68196
Product ID 68196-029_15245ea7-be50-4512-af1f-95bfd0bea453
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Sam's West Inc
Application ANDA076775
Marketing category ANDA
Marketing start 2005-09-30
Substance NICOTINE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base members mark 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 68196-029-01 members mark nicotine 2 in 1 PACKAGE GUM, CHEWING 2 8 68196-029-06 members mark nicotine 160 in 1 CARTON GUM, CHEWING 160 8 68196-029-06 members mark nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 68196-029-36 members mark nicotine 160 in 1 CARTON GUM, CHEWING 160 8 68196-029-36 members mark nicotine 2 in 1 PACKAGE GUM, CHEWING 2 8 68196-029-38 members mark nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 68196-029-38 members mark nicotine 380 in 1 CARTON GUM, CHEWING 380 8 68196-029-56 members mark nicotine 190 in 1 CARTON GUM, CHEWING 190 8 68196-029-56 members mark nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 68196-029-70 members mark nicotine 2 in 1 PACKAGE GUM, CHEWING 2 8 68196-029-70 members mark nicotine 120 in 1 CARTON GUM, CHEWING 120 8 68196-029-76 members mark nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 8 68196-029-76 members mark nicotine 120 in 1 CARTON GUM, CHEWING 120 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 NICOTINE ACTIVE MOIETY 6M3C89ZY6R MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-029 MEMBERS MARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [SAM'S WEST INC] 7 Current NDC, Legacy NDC, 13 package rows 20240713_2c43a498-a4fb-4ed1-b4ae-aecfd334945b.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 68196-029-01 68196002901 2 CARTON in 1 PACKAGE (68196-029-01) / 190 BLISTER PACK in 1 CARTON (68196-029-56) / 1 GUM, CHEWING in 1 BLISTER PACK 2 carton 2019-06-22 0000-00-00 No No Current 68196-029-06 68196002906 160 in 1 CARTON Historical 68196-029-36 68196002936 160 in 1 CARTON Historical 68196-029-38 68196002938 380 BLISTER PACK in 1 CARTON (68196-029-38) / 1 GUM, CHEWING in 1 BLISTER PACK 380 blister pack 2025-09-16 No No Current 68196-029-56 68196002956 190 in 1 CARTON Historical 68196-029-70 68196002970 2 in 1 PACKAGE Historical 68196-029-76 68196002976 1 in 1 BLISTER PACK Historical