FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-808
11-digit product format
722880808
Labeler code
72288
Product ID
72288-808_f3fe8893-b13f-499c-93a7-3868f2ec3134
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA203690
Marketing category
ANDA
Marketing start
2021-08-06
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
72288-808-09basic care nicotine1 in 1 CARTONLOZENGE13
72288-808-09basic care nicotine27 in 1 CONTAINERLOZENGE273
72288-808-14basic care nicotine5 in 1 CARTONLOZENGE53
72288-808-14basic care nicotine27 in 1 CONTAINERLOZENGE273

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-808BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20210817_41ae65b3-2e4e-4306-959d-be44c7d205fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN41ae65b3-2e4e-4306-959d-be44c7d205fe3
359817nicotine 2 MG Oral LozengeSCD41ae65b3-2e4e-4306-959d-be44c7d205fe3
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY41ae65b3-2e4e-4306-959d-be44c7d205fe3
359817nicotine 2 MG TrocheSY41ae65b3-2e4e-4306-959d-be44c7d205fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-808-09722880808091 CONTAINER in 1 CARTON (72288-808-09) / 27 LOZENGE in 1 CONTAINER1 container2021-08-060000-00-00NoNoCurrent
72288-808-14722880808145 CONTAINER in 1 CARTON (72288-808-14) / 27 LOZENGE in 1 CONTAINER5 container2021-08-060000-00-00NoNoCurrent