FDA.reportPublic FDA data

Basic Care Nicotine

Product NDC
72288-077
11-digit product format
722880077
Labeler code
72288
Product ID
72288-077_5b51720a-2a96-4960-85f3-d8772badd4a2
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
2021-08-23
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
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
72288-077-09Basic Care Nicotine27 in 1 CONTAINERLOZENGE273
72288-077-09Basic Care Nicotine1 in 1 CARTONLOZENGE13
72288-077-14Basic Care Nicotine27 in 1 CONTAINERLOZENGE273
72288-077-14Basic Care Nicotine5 in 1 CARTONLOZENGE53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-077BASIC CARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMAZON.COM SERVICES LLC]2Current NDC, Legacy NDC, 4 package rows20220630_03b27d95-f2cb-43d4-9bc3-55ea66fadb0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN03b27d95-f2cb-43d4-9bc3-55ea66fadb0d3
359818nicotine 4 MG Oral LozengeSCD03b27d95-f2cb-43d4-9bc3-55ea66fadb0d3
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY03b27d95-f2cb-43d4-9bc3-55ea66fadb0d3
359818nicotine 4 MG TrocheSY03b27d95-f2cb-43d4-9bc3-55ea66fadb0d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-077-09722880077091 CONTAINER in 1 CARTON (72288-077-09) / 27 LOZENGE in 1 CONTAINER1 container2021-09-020000-00-00NoNoCurrent
72288-077-14722880077145 CONTAINER in 1 CARTON (72288-077-14) / 27 LOZENGE in 1 CONTAINER5 container2021-08-230000-00-00NoNoCurrent