FDA.reportPublic FDA data

Topcare Nicotine

Product NDC
36800-532
11-digit product format
368000532
Labeler code
36800
Product ID
36800-532_e3063a6a-a7d8-4aa1-9f69-36f812ed2d51
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA076779
Marketing category
ANDA
Marketing start
2006-10-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-532-60Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
36800-532-60Topcare Nicotine20 in 1 CARTONGUM, CHEWING2012
36800-532-76Topcare Nicotine120 in 1 CARTONGUM, CHEWING12012
36800-532-76Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING112
36800-532-78Topcare Nicotine100 in 1 CARTONGUM, CHEWING10012
36800-532-78Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-532-60EA - Each36800-532c68d914c-a94f-4d4a-a0b0-bb49d309195d12020-04-20
36800-532-78EA - Each36800-532e9433b02-db83-4733-9fee-d23cb7bffa1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
NICOTINEACTIVE MOIETY6M3C89ZY6RTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
GELATININACTIVE INGREDIENT2G86QN327LTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
POLACRILININACTIVE INGREDIENTRCZ785HI7STOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ETOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-532TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]12Current NDC, Legacy NDC, 6 package rows20250425_fa916f6b-0582-4e2a-bbed-6c47778c5d03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNfa916f6b-0582-4e2a-bbed-6c47778c5d0312
311975nicotine 4 MG Chewing GumSCDfa916f6b-0582-4e2a-bbed-6c47778c5d0312
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYfa916f6b-0582-4e2a-bbed-6c47778c5d0312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-532-603680005326020 BLISTER PACK in 1 CARTON (36800-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-01-230000-00-00NoNoCurrent
36800-532-7636800053276120 BLISTER PACK in 1 CARTON (36800-532-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2014-08-250000-00-00NoNoCurrent
36800-532-7836800053278100 BLISTER PACK in 1 CARTON (36800-532-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2006-10-300000-00-00NoNoCurrent