Home NDC 37808-753 Nicotine
Product NDC 37808-753
11-digit product format 378080753
Labeler code 37808
Product ID 37808-753_f70627db-fcc2-4786-8da2-732293e33cb5
Type HUMAN OTC DRUG
Nonproprietary name nicotine
Dosage form GUM, CHEWING
Route ORAL
Labeler H E B
Application ANDA078326
Marketing category ANDA
Marketing start 2019-05-06
Substance NICOTINE
Active strength 4 mg/1
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A078326-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30
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 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078326-001 NICOTINE POLACRILEX EQ 4MG BASE GUM, CHEWING / BUCCAL 2006-10-30 cb3db0bc1861…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-753-96 Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 3 37808-753-96 Nicotine 170 in 1 CARTON GUM, CHEWING 170 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-753 NICOTINE GUM, CHEWING [H E B] 3 Current NDC, Legacy NDC, 2 package rows 20210409_9081d573-b950-4f5e-b1bc-e77fc2ae00c5.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 · 2 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 37808-753-96 37808075396 170 BLISTER PACK in 1 CARTON (37808-753-96) / 1 GUM, CHEWING in 1 BLISTER PACK 170 blister pack 2019-05-06 0000-00-00 No No Current