FDA.reportPublic FDA data

basic care nicotine

Product NDC
72288-642
11-digit product format
722880642
Labeler code
72288
Product ID
72288-642_c67d132b-ef81-458f-aa04-caa01da36fbf
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
2021-04-29
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
Rxcui359818

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
72288-642-07basic care nicotine3 in 1 CARTONLOZENGE33
72288-642-09basic care nicotine27 in 1 CONTAINERLOZENGE273
72288-642-60basic care nicotine20 in 1 CONTAINERLOZENGE203
72288-642-60basic care nicotine1 in 1 CARTONLOZENGE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-642BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20220624_f3035ca0-8739-4d77-af97-f6021d6478c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNf3035ca0-8739-4d77-af97-f6021d6478c23
359818nicotine 4 MG Oral LozengeSCDf3035ca0-8739-4d77-af97-f6021d6478c23
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYf3035ca0-8739-4d77-af97-f6021d6478c23
359818nicotine 4 MG TrocheSYf3035ca0-8739-4d77-af97-f6021d6478c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-642-07722880642073 CONTAINER in 1 CARTON (72288-642-07) / 27 LOZENGE in 1 CONTAINER (72288-642-09) 3 container2021-04-290000-00-00NoNoCurrent
72288-642-097228806420927 LOZENGE in 1 CONTAINER (72288-642-09) 27 lozenge2022-05-050000-00-00NoNoCurrent
72288-642-60722880642601 CONTAINER in 1 CARTON (72288-642-60) > 20 LOZENGE in 1 CONTAINER1 container2022-05-050000-00-00NoNoCurrent