FDA.reportPublic FDA data

Nicotine

Product NDC
0536-1337
11-digit product format
005361337
Labeler code
0536
Product ID
0536-1337_09bfc71c-cebe-4d12-8c99-d5b2017f5a79
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
ANDA209206
Marketing category
ANDA
Marketing start
2021-09-17
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
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
0536-1337-09Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245
0536-1337-09Nicotine3 in 1 BOXLOZENGE35
0536-1337-35Nicotine1 in 1 BOXLOZENGE15
0536-1337-35Nicotine24 in 1 BOTTLE, PLASTICLOZENGE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1337-09EA - Each0536-13377c513396-5736-47f9-85a8-04ea4a7af31812021-12-08
0536-1337-35EA - Each0536-13376a294b4d-b5d8-4e5d-8ddb-bc02e98eee4d12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1337NICOTINE (NICOTINE POLACRILEX) LOZENGE [RUGBY LABORATORIES, INC.]3Current NDC, Legacy NDC, 4 package rows20250112_150faf42-491f-403b-869b-48edd431d1cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN150faf42-491f-403b-869b-48edd431d1cc5
359817nicotine 2 MG Oral LozengeSCD150faf42-491f-403b-869b-48edd431d1cc5
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY150faf42-491f-403b-869b-48edd431d1cc5
359817nicotine 2 MG TrocheSY150faf42-491f-403b-869b-48edd431d1cc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1337-09005361337093 BOTTLE, PLASTIC in 1 BOX (0536-1337-09) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-09-170000-00-00NoNoCurrent
0536-1337-35005361337351 BOTTLE, PLASTIC in 1 BOX (0536-1337-35) / 24 LOZENGE in 1 BOTTLE, PLASTIC2021-09-17NoNoCurrent