FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-223
11-digit product format
722880223
Labeler code
72288
Product ID
72288-223_ebf2ad10-e6ab-4542-b7c6-84af9d2832eb
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
2021-05-06
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-223-07basic care nicotine27 in 1 CONTAINERLOZENGE272
72288-223-07basic care nicotine3 in 1 CARTONLOZENGE32
72288-223-60basic care nicotine20 in 1 CONTAINERLOZENGE202
72288-223-60basic care nicotine1 in 1 CARTONLOZENGE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-223BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20220615_8b6d7617-ce92-4bad-9f38-81a7f2e9cfa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32
359817nicotine 2 MG Oral LozengeSCD8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32
359817nicotine 2 MG TrocheSY8b6d7617-ce92-4bad-9f38-81a7f2e9cfa32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-223-07722880223073 CONTAINER in 1 CARTON (72288-223-07) / 27 LOZENGE in 1 CONTAINER3 container2022-05-130000-00-00NoNoCurrent
72288-223-60722880223601 CONTAINER in 1 CARTON (72288-223-60) / 20 LOZENGE in 1 CONTAINER1 container2021-05-060000-00-00NoNoCurrent