FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-029
11-digit product format
722880029
Labeler code
72288
Product ID
72288-029_84629172-fdaf-42ae-865f-d2a269413ab4
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA076775
Marketing category
ANDA
Marketing start
2021-06-17
Substance
NICOTINE
Active strength
2 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R

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
72288-029-02basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-029-02basic care nicotine310 in 1 CARTONGUM, CHEWING3103
72288-029-29basic care nicotine220 in 1 CARTONGUM, CHEWING2203
72288-029-29basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-029-60basic care nicotine1 in 1 BLISTER PACKGUM, CHEWING13
72288-029-60basic care nicotine20 in 1 CARTONGUM, CHEWING203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-029BASIC CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 6 package rows20250326_90f2da70-c58f-44fb-bdbd-5c95440c1198.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN90f2da70-c58f-44fb-bdbd-5c95440c11983
314119nicotine 2 MG Chewing GumSCD90f2da70-c58f-44fb-bdbd-5c95440c11983
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY90f2da70-c58f-44fb-bdbd-5c95440c11983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-029-0272288002902310 BLISTER PACK in 1 CARTON (72288-029-02) / 1 GUM, CHEWING in 1 BLISTER PACK310 blister pack2021-10-140000-00-00NoNoCurrent
72288-029-2972288002929220 BLISTER PACK in 1 CARTON (72288-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2021-06-170000-00-00NoNoCurrent
72288-029-607228800296020 BLISTER PACK in 1 CARTON (72288-029-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-06-220000-00-00NoNoCurrent