FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-344
11-digit product format
722880344
Labeler code
72288
Product ID
72288-344_384a94be-0b87-4c1a-ba48-1f5f64e47d89
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA077007
Marketing category
ANDA
Marketing start
2021-05-07
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
72288-344-03basic care nicotine1 in 1 CARTONLOZENGE12
72288-344-03basic care nicotine24 in 1 CONTAINERLOZENGE242
72288-344-09basic care nicotine27 in 1 CONTAINERLOZENGE272
72288-344-14basic care nicotine8 in 1 CARTONLOZENGE82
72288-344-16basic care nicotine24 in 1 CONTAINERLOZENGE242
72288-344-16basic care nicotine6 in 1 CARTONLOZENGE62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-344BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 6 package rows20210729_6b500780-f45c-477c-8371-3b60e3305000.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN6b500780-f45c-477c-8371-3b60e33050002
359817nicotine 2 MG Oral LozengeSCD6b500780-f45c-477c-8371-3b60e33050002
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY6b500780-f45c-477c-8371-3b60e33050002
359817nicotine 2 MG TrocheSY6b500780-f45c-477c-8371-3b60e33050002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-344-03722880344031 CONTAINER in 1 CARTON (72288-344-03) / 24 LOZENGE in 1 CONTAINER1 container2021-05-200000-00-00NoNoCurrent
72288-344-097228803440927 in 1 CONTAINERHistorical
72288-344-14722880344148 CONTAINER in 1 CARTON (72288-344-14) / 27 LOZENGE in 1 CONTAINER (72288-344-09) 8 container2021-05-200000-00-00NoNoCurrent
72288-344-16722880344166 CONTAINER in 1 CARTON (72288-344-16) / 24 LOZENGE in 1 CONTAINER6 container2021-05-070000-00-00NoNoCurrent