FDA.reportPublic FDA data

Nicotine

Product NDC
69842-564
11-digit product format
698420564
Labeler code
69842
Product ID
69842-564_da20b0a7-14b7-49eb-90c7-86cc890aff8b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA207868
Marketing category
ANDA
Marketing start
2020-05-29
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
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-564-10Nicotine1 in 1 BOXLOZENGE13
69842-564-10Nicotine10 in 1 BOTTLE, PLASTICLOZENGE103
69842-564-20Nicotine1 in 1 BOXLOZENGE13
69842-564-20Nicotine20 in 1 BOTTLE, PLASTICLOZENGE203
69842-564-27Nicotine27 in 1 BOTTLE, PLASTICLOZENGE273
69842-564-27Nicotine1 in 1 BOXLOZENGE13
69842-564-35Nicotine27 in 1 BOTTLE, PLASTICLOZENGE273
69842-564-35Nicotine5 in 1 BOXLOZENGE53
69842-564-81Nicotine27 in 1 BOTTLE, PLASTICLOZENGE273
69842-564-81Nicotine3 in 1 BOXLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-564NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]3Current NDC, Legacy NDC, 10 package rows20221123_7fa848c6-3a4a-41f3-b927-1b26b6232e3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN7fa848c6-3a4a-41f3-b927-1b26b6232e3a3
359818nicotine 4 MG Oral LozengeSCD7fa848c6-3a4a-41f3-b927-1b26b6232e3a3
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY7fa848c6-3a4a-41f3-b927-1b26b6232e3a3
359818nicotine 4 MG TrocheSY7fa848c6-3a4a-41f3-b927-1b26b6232e3a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-564-10698420564101 BOTTLE, PLASTIC in 1 BOX (69842-564-10) / 10 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-564-20698420564201 BOTTLE, PLASTIC in 1 BOX (69842-564-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-564-27698420564271 BOTTLE, PLASTIC in 1 BOX (69842-564-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-564-35698420564355 BOTTLE, PLASTIC in 1 BOX (69842-564-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent
69842-564-81698420564813 BOTTLE, PLASTIC in 1 BOX (69842-564-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC2020-05-290000-00-00NoNoCurrent