Home NDC 36800-206 Topcare Nicotine
Product NDC 36800-206
11-digit product format 368000206
Labeler code 36800
Product ID 36800-206_77e8701e-f9a3-42bf-ac4d-424b9e96d7fc
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Topco Associates LLC
Application ANDA078325
Marketing category ANDA
Marketing start 2005-04-22
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 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 A078325-001 NICOTINE POLACRILEX NICOTINE POLACRILEX EQ 2MG 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 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078325-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2006-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078325-001 NICOTINE POLACRILEX EQ 2MG 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 36800-206-25 Topcare Nicotine 110 in 1 CARTON GUM, CHEWING 110 7 36800-206-25 Topcare Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 NICOTINE ACTIVE MOIETY 6M3C89ZY6R TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-206 TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 2 package rows 20210409_0ee4ea1d-eac9-4282-b3a4-359f3319fdee.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 · 1 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 36800-206-25 36800020625 110 BLISTER PACK in 1 CARTON (36800-206-25) / 1 GUM, CHEWING in 1 BLISTER PACK 110 blister pack 2005-04-22 0000-00-00 No No Current