BOTASUN QUIT SMOKING Nicotine

Product NDC
85248-189
11-digit product format
852480189
Labeler code
85248
Product ID
85248-189_4fa00db9-def6-dcfa-e063-6394a90ac8c2
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine18% menthol 0.3% QUIT SMOKING Nicotine
Dosage form
PATCH
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-17
Substance
MENTHOL; NICOTINE
Active strength
.3; 18 g/1001; g/1001
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BOTASUN QUIT SMOKING Nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.3 g/1001
NICOTINE18 g/1001

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, 6M3C89ZY6R

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
85248-189-01BOTASUN QUIT SMOKING Nicotine21 in 1 BOXPATCH211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-189-018524801890121 PATCH in 1 BOX (85248-189-01) 21 patch2026-04-17NoNoCurrent