FDA.reportPublic FDA data

Rugby Nicotine Polacrilex Gum, Mint Flavor

Product NDC
0536-1362
Requested package NDC
0536-1362-23
11-digit product format
005361362
Labeler code
0536
Product ID
0536-1362_3264fa2c-9a96-4aff-979b-d83a990d0fcf
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Rugby Laboratories
Application
ANDA076569
Marketing category
ANDA
Marketing start
2004-07-29
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-13620536-1362-23DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076569-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076569-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL2004-07-29a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Polacrilex MINTNICOTINE POLACRILEXWalgreens53c5ae28-5638-4217-9080-2bceba9a88852026-05-19WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461225efd7a3c-b36c-4355-a646-bfeb7ba30ce52026-03-17WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-02-26WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
ndc (package): 0536-1362-23
ndc (product): 0536-1362
ndc11 (package): 00536136223
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXA-S Medication Solutions7b70162e-0087-466f-9b8b-8289b6e90e392025-09-23WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.62609a8d-bcbe-420c-aed8-edfdf022ff262025-06-27WarningsExact identifier
application applno (ANDA): 076569
application number: ANDA076569

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Nicotine Polacrilex Gum, Mint Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311975Internal RxNorm lookup
314119Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1362-06Rugby Nicotine Polacrilex Gum, Mint Flavor5 in 1 CARTONGUM, CHEWING518
0536-1362-06Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-1362-23Rugby Nicotine Polacrilex Gum, Mint Flavor11 in 1 CARTONGUM, CHEWING1118
0536-1362-23Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-1362-34Rugby Nicotine Polacrilex Gum, Mint Flavor2 in 1 CARTONGUM, CHEWING218
0536-1362-34Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1362-06EA - Each0536-1362f6aa756d-b9bf-4a97-9457-55210ab98cf212013-02-13
0536-1362-23EA - Each0536-1362b9e570a5-cd24-4c9b-bf29-fd400f0f6ba412013-02-13
0536-1362-34EA - Each0536-1362eebac00b-7910-4f44-9425-2020c54654e712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ERUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1362RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]16Current NDC, Legacy NDC, 6 package rows20241219_0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
311975nicotine polacrilex 4 MG Chewing GumPSN0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
314119nicotine 2 MG Chewing GumSCD0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
311975nicotine 4 MG Chewing GumSCD0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY0f5af06c-ab1c-48d0-a39f-4d1d7e78ff2518
314119nicotine polacrilex 2 MG Chewing GumPSN7b70162e-0087-466f-9b8b-8289b6e90e3916
314119nicotine 2 MG Chewing GumSCD7b70162e-0087-466f-9b8b-8289b6e90e3916
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY7b70162e-0087-466f-9b8b-8289b6e90e3916
314119nicotine polacrilex 2 MG Chewing GumPSN62609a8d-bcbe-420c-aed8-edfdf022ff264
314119nicotine 2 MG Chewing GumSCD62609a8d-bcbe-420c-aed8-edfdf022ff264
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY62609a8d-bcbe-420c-aed8-edfdf022ff264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1362-230053613622311 BLISTER PACK in 1 CARTON (0536-1362-23) / 10 GUM, CHEWING in 1 BLISTER PACK11 blister pack2004-07-290000-00-00NoNoCurrent