Home NDC 69842-608 Nicotine Polacrilex
Product NDC 69842-608
11-digit product format 698420608
Labeler code 69842
Product ID 69842-608_0ab21cfd-645a-4c3a-b497-f77099ed1c9f
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler CVS Pharmacy
Application ANDA074507
Marketing category ANDA
Marketing start 2014-01-01
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 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 A074507-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15
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 · 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 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Polacrilex
Brand name suffix original
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311975 Internal RxNorm lookup 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 69842-608-15 Nicotine Polacrilexoriginal 1 in 1 BLISTER PACK GUM, CHEWING 1 17 69842-608-15 Nicotine Polacrilexoriginal 20 in 1 CARTON GUM, CHEWING 20 17 69842-608-50 Nicotine Polacrilexoriginal 50 in 1 CARTON GUM, CHEWING 50 17 69842-608-50 Nicotine Polacrilexoriginal 1 in 1 BLISTER PACK GUM, CHEWING 1 17 69842-608-79 Nicotine Polacrilexoriginal 10 in 1 CARTON GUM, CHEWING 10 17 69842-608-79 Nicotine Polacrilexoriginal 1 in 1 BLISTER PACK GUM, CHEWING 1 17 69842-608-98 Nicotine Polacrilexoriginal 1 in 1 BLISTER PACK GUM, CHEWING 1 17 69842-608-98 Nicotine Polacrilexoriginal 170 in 1 CARTON GUM, CHEWING 170 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-608 NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CVS PHARMACY] 11 Current NDC, Legacy NDC, 8 package rows 20241006_62231539-ae9f-4665-ba59-bef047e93d8a.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 69842-608-15 69842060815 20 BLISTER PACK in 1 CARTON (69842-608-15) / 1 GUM, CHEWING in 1 BLISTER PACK 20 blister pack 2014-01-01 0000-00-00 No No Current 69842-608-50 69842060850 50 BLISTER PACK in 1 CARTON (69842-608-50) / 1 GUM, CHEWING in 1 BLISTER PACK 50 blister pack 2014-01-01 0000-00-00 No No Current 69842-608-79 69842060879 10 BLISTER PACK in 1 CARTON (69842-608-79) / 1 GUM, CHEWING in 1 BLISTER PACK 10 blister pack 2014-01-01 0000-00-00 No No Current 69842-608-98 69842060898 170 BLISTER PACK in 1 CARTON (69842-608-98) / 1 GUM, CHEWING in 1 BLISTER PACK 170 blister pack 2014-01-01 0000-00-00 No No Current