FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-170
11-digit product format
722880170
Labeler code
72288
Product ID
72288-170_8544e051-d6d8-4817-8b22-4ed86ac8bc3c
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA076789
Marketing category
ANDA
Marketing start
2021-01-07
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
basic care 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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-170-02basic care nicotine310 in 1 CARTONGUM, CHEWING3103
72288-170-02basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-170-29basic care nicotine220 in 1 CARTONGUM, CHEWING2203
72288-170-29basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-170-60basic care nicotine20 in 1 CARTONGUM, CHEWING203
72288-170-60basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-170BASIC CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 6 package rows20211023_63ac801f-02ed-43a1-a2a8-2ad35d8fd7a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN63ac801f-02ed-43a1-a2a8-2ad35d8fd7a93
311975nicotine 4 MG Chewing GumSCD63ac801f-02ed-43a1-a2a8-2ad35d8fd7a93
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY63ac801f-02ed-43a1-a2a8-2ad35d8fd7a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-170-0272288017002310 BLISTER PACK in 1 CARTON (72288-170-02) / 1 GUM, CHEWING in 1 BLISTER PACK310 blister pack2021-10-140000-00-00NoNoCurrent
72288-170-2972288017029220 BLISTER PACK in 1 CARTON (72288-170-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2021-10-210000-00-00NoNoCurrent
72288-170-607228801706020 BLISTER PACK in 1 CARTON (72288-170-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-01-070000-00-00NoNoCurrent