Mini Nicotine

Product NDC
46122-716
11-digit product format
461220716
Labeler code
46122
Product ID
46122-716_7100dc63-397a-4caf-80c3-c43e0e5f0054
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
ANDA207868
Marketing category
ANDA
Marketing start
2023-02-08
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
Mini 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
46122-716-15Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE275
46122-716-15Mini Nicotine3 in 1 BOXLOZENGE35
46122-716-16Mini Nicotine1 in 1 BOXLOZENGE15
46122-716-16Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE275
46122-716-60Mini Nicotine1 in 1 BOXLOZENGE15
46122-716-60Mini Nicotine20 in 1 BOTTLE, PLASTICLOZENGE205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-716-15EA - Each46122-716fdfda4bc-9025-47fc-9dfa-12f4382bd22b12023-05-05
46122-716-60EA - Each46122-716550cd61e-0f12-467e-9c12-dc4ac1567e7312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-716MINI NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]5Current NDC, Legacy NDC, 6 package rows20250131_7f1cdc21-d213-4ede-86fd-e11b31dfab58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN7f1cdc21-d213-4ede-86fd-e11b31dfab585
359818nicotine 4 MG Oral LozengeSCD7f1cdc21-d213-4ede-86fd-e11b31dfab585
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY7f1cdc21-d213-4ede-86fd-e11b31dfab585
359818nicotine 4 MG TrocheSY7f1cdc21-d213-4ede-86fd-e11b31dfab585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-716-15461220716153 BOTTLE, PLASTIC in 1 BOX (46122-716-15) / 27 LOZENGE in 1 BOTTLE, PLASTIC2023-02-080000-00-00NoNoCurrent
46122-716-16461220716161 BOTTLE, PLASTIC in 1 BOX (46122-716-16) / 27 LOZENGE in 1 BOTTLE, PLASTIC2023-02-080000-00-00NoNoCurrent
46122-716-60461220716601 BOTTLE, PLASTIC in 1 BOX (46122-716-60) / 20 LOZENGE in 1 BOTTLE, PLASTIC2023-02-220000-00-00NoNoCurrent