FDA.reportPublic FDA data

Topcare Nicotine

Product NDC
36800-170
11-digit product format
368000170
Labeler code
36800
Product ID
36800-170_4f06963f-85fc-408a-bc4d-8bc3352f10d5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA076789
Marketing category
ANDA
Marketing start
2005-04-19
Substance
NICOTINE
Active strength
4 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
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-170-25Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING111
36800-170-25Topcare Nicotine110 in 1 CARTONGUM, CHEWING11011
36800-170-60Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING111
36800-170-60Topcare Nicotine20 in 1 CARTONGUM, CHEWING2011
36800-170-71Topcare Nicotine1 in 1 BLISTER PACKGUM, CHEWING111
36800-170-71Topcare Nicotine50 in 1 CARTONGUM, CHEWING5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-170-25EA - Each36800-1701cf0c698-2f23-4a1d-bdb0-822a3b56810912012-07-24
36800-170-71EA - Each36800-170a037389f-37c9-4357-a2f4-a2f0c056a79812012-07-24

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
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-170TOPCARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [TOPCO ASSOCIATES LLC]10Current NDC, Legacy NDC, 6 package rows20250403_1a916693-6092-4875-872a-7438816c0ddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN1a916693-6092-4875-872a-7438816c0ddf11
311975nicotine 4 MG Chewing GumSCD1a916693-6092-4875-872a-7438816c0ddf11
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY1a916693-6092-4875-872a-7438816c0ddf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-170-2536800017025110 BLISTER PACK in 1 CARTON (36800-170-25) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2005-04-200000-00-00NoNoCurrent
36800-170-603680001706020 BLISTER PACK in 1 CARTON (36800-170-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-02-140000-00-00NoNoCurrent
36800-170-713680001707150 BLISTER PACK in 1 CARTON (36800-170-71) > 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2005-04-190000-00-00NoNoCurrent