FDA.reportPublic FDA data

Sielkin QUIT SMOKING NICOTINE PATCHES

Product NDC
83364-015
11-digit product format
833640015
Labeler code
83364
Product ID
83364-015_497a4c96-6134-0829-e063-6294a90a34d0
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-01
Substance
NICOTINE
Active strength
7 mg/g
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
Sielkin QUIT SMOKING NICOTINE PATCHES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198031

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
83364-015-01Sielkin QUIT SMOKING NICOTINE PATCHES0.007 g in 1 PATCHPATCH0.0072
83364-015-01Sielkin QUIT SMOKING NICOTINE PATCHES30 in 1 BOXPATCH302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83364-015SIELKIN QUIT SMOKING NICOTINE PATCHES (NICOTINE) PATCH [YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD]1Current NDC, 2 package rows20241222_2969f3cc-8e45-f93d-e063-6294a90a93ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN2969f3cc-8e45-f93d-e063-6294a90a93ad2
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD2969f3cc-8e45-f93d-e063-6294a90a93ad2
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY2969f3cc-8e45-f93d-e063-6294a90a93ad2
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY2969f3cc-8e45-f93d-e063-6294a90a93ad2
198031nicotine 7 MG/Day 24HR Transdermal SystemSY2969f3cc-8e45-f93d-e063-6294a90a93ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83364-015-018336400150130 PATCH in 1 BOX (83364-015-01) / .007 g in 1 PATCH30 patch2026-01-01NoNoCurrent