FDA.reportPublic FDA data

Topcare Nicotine

Product NDC
36800-456
11-digit product format
368000456
Labeler code
36800
Product ID
36800-456_c38bbaa6-c1a2-4627-9c2c-67dd6f6fbfa6
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA076777
Marketing category
ANDA
Marketing start
2006-12-18
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

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-456-60Topcare Nicotine20 in 1 CARTONGUM, CHEWING2013
36800-456-60Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING113
36800-456-76Topcare Nicotine120 in 1 CARTONGUM, CHEWING12013
36800-456-76Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING113
36800-456-78Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING113
36800-456-78Topcare Nicotine100 in 1 CARTONGUM, CHEWING10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-456-60EA - Each36800-456119d4d3c-ee6e-4dd0-8bc5-09056366ec9d12024-04-05
36800-456-78EA - Each36800-4562ea25d22-6585-4c18-9d99-52368dce4bd512012-07-24

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
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
36800-456TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]12Current NDC, Legacy NDC, 6 package rows20240413_440178c0-e9e4-4729-bcd9-f640742c4080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN440178c0-e9e4-4729-bcd9-f640742c408013
314119nicotine 2 MG Chewing GumSCD440178c0-e9e4-4729-bcd9-f640742c408013
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY440178c0-e9e4-4729-bcd9-f640742c408013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-456-603680004566020 BLISTER PACK in 1 CARTON (36800-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-02-060000-00-00NoNoCurrent
36800-456-7636800045676120 BLISTER PACK in 1 CARTON (36800-456-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2014-08-190000-00-00NoNoCurrent
36800-456-7836800045678100 BLISTER PACK in 1 CARTON (36800-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2006-12-180000-00-00NoNoCurrent