Home NDC 36800-029-60 TopCare Nicotine
Product NDC 36800-029
Requested package NDC 36800-029-60
11-digit product format 368000029
Labeler code 36800
Product ID 36800-029_2a9d5005-ccae-4539-b949-e3d189cbb2a0
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route ORAL
Labeler Topco Associates LLC
Application ANDA076775
Marketing category ANDA
Marketing start 2005-04-20
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 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.
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 2026-08-01 22:54:32 2026-06 A076775-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 2004-09-16 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 15 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base TopCare 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 36800-029-25 TopCare Nicotine 110 in 1 CARTON GUM, CHEWING 110 10 36800-029-25 TopCare Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 36800-029-60 TopCare Nicotine 1 in 1 BLISTER PACK GUM, CHEWING 1 10 36800-029-60 TopCare Nicotine 20 in 1 CARTON GUM, CHEWING 20 10
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] 5 NICOTINE ACTIVE MOIETY 6M3C89ZY6R TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 POLACRILIN INACTIVE INGREDIENT RCZ785HI7S TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-029 TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC] 9 Current NDC, Legacy NDC, 4 package rows 20250327_beb2eddc-0fec-4f64-bceb-4e9bcee3616c.zip
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 36800-029-60 36800002960 20 BLISTER PACK in 1 CARTON (36800-029-60) > 1 GUM, CHEWING in 1 BLISTER PACK 20 blister pack 2013-02-12 0000-00-00 No No Current