Home NDC 0536-3029 Rugby Nicotine Polacrilex Gum, Original Flavor
Product NDC 0536-3029
11-digit product format 005363029
Labeler code 0536
Product ID 0536-3029_a7fad73a-749d-4287-b756-2cd203b85d35
Type HUMAN OTC DRUG
Nonproprietary name Nicotine Polacrilex
Dosage form GUM, CHEWING
Route BUCCAL
Labeler Rugby Laboratories
Application ANDA074507
Marketing category ANDA
Marketing start 1999-03-15
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.
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 A074507-001 NICOTINE POLACRILEX EQ 2MG BASE GUM, CHEWING / BUCCAL 1999-03-15 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 · 11 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Rugby Nicotine Polacrilex Gum, Original Flavor
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 0536-3029-06 Rugby Nicotine Polacrilex Gum, Original Flavor 5 in 1 CARTON GUM, CHEWING 5 27 0536-3029-06 Rugby Nicotine Polacrilex Gum, Original Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 27 0536-3029-23 Rugby Nicotine Polacrilex Gum, Original Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 27 0536-3029-23 Rugby Nicotine Polacrilex Gum, Original Flavor 11 in 1 CARTON GUM, CHEWING 11 27 0536-3029-34 Rugby Nicotine Polacrilex Gum, Original Flavor 10 in 1 BLISTER PACK GUM, CHEWING 10 27 0536-3029-34 Rugby Nicotine Polacrilex Gum, Original Flavor 2 in 1 CARTON GUM, CHEWING 2 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NICOTINE ACTIVE INGREDIENT 6M3C89ZY6R RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 NICOTINE ACTIVE MOIETY 6M3C89ZY6R RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 SORBITOL INACTIVE INGREDIENT 506T60A25R RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-3029 RUGBY NICOTINE POLACRILEX GUM, ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.] 24 Current NDC, Legacy NDC, 6 package rows 20250201_1fc88637-4329-486e-82ab-19eeb06080a6.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 0536-3029-06 00536302906 5 BLISTER PACK in 1 CARTON (0536-3029-06) / 10 GUM, CHEWING in 1 BLISTER PACK 5 blister pack 1999-03-15 0000-00-00 No No Current 0536-3029-23 00536302923 11 BLISTER PACK in 1 CARTON (0536-3029-23) / 10 GUM, CHEWING in 1 BLISTER PACK 11 blister pack 1999-03-15 0000-00-00 No No Current 0536-3029-34 00536302934 2 BLISTER PACK in 1 CARTON (0536-3029-34) / 10 GUM, CHEWING in 1 BLISTER PACK 2 blister pack 1999-03-15 0000-00-00 No No Current