FDA.reportPublic FDA data

Basic Care Nicotine

Product NDC
72288-003
11-digit product format
722880003
Labeler code
72288
Product ID
72288-003_7074da6a-f3f9-43f7-91b2-986660bd0394
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA206393
Marketing category
ANDA
Marketing start
2021-07-31
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
72288-003-06Basic Care Nicotine160 in 1 CARTONGUM, CHEWING1602
72288-003-06Basic Care Nicotine1 in 1 BLISTER PACKGUM, CHEWING12
72288-003-60Basic Care Nicotine20 in 1 CARTONGUM, CHEWING202
72288-003-60Basic Care Nicotine1 in 1 BLISTER PACKGUM, CHEWING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-003BASIC CARE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20250309_bbeb84ae-c98f-422e-9770-e44961af593f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNbbeb84ae-c98f-422e-9770-e44961af593f2
311975nicotine 4 MG Chewing GumSCDbbeb84ae-c98f-422e-9770-e44961af593f2
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYbbeb84ae-c98f-422e-9770-e44961af593f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-003-0672288000306160 BLISTER PACK in 1 CARTON (72288-003-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2021-08-110000-00-00NoNoCurrent
72288-003-607228800036020 BLISTER PACK in 1 CARTON (72288-003-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2021-07-310000-00-00NoNoCurrent