FDA.reportPublic FDA data

Quit Smoking Nicotine Patches

Product NDC
85835-001
11-digit product format
858350001
Labeler code
85835
Product ID
85835-001_38c1616e-3b0a-0669-e063-6294a90a2c86
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal Patches
Dosage form
PATCH
Route
TOPICAL
Labeler
Shenzhen Paxi Trading Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
NICOTINE
Active strength
28 mg/1001
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
Quit Smoking Nicotine Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE28 mg/1001

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui2707585

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
85835-001-01Quit Smoking Nicotine Patches15 in 1 BOXPATCH151
85835-001-02Quit Smoking Nicotine Patches30 in 1 BOXPATCH301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707585nicotine 28 MG/Day 24HR Transdermal PatchPSN38c1616e-3b09-0669-e063-6294a90a2c861
270758524 HR nicotine 1.17 MG/HR Transdermal SystemSCD38c1616e-3b09-0669-e063-6294a90a2c861
2707585nicotine 28 MG/Day 24 HR Transdermal PatchSY38c1616e-3b09-0669-e063-6294a90a2c861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85835-001-018583500010115 PATCH in 1 BOX (85835-001-01) 15 patch2025-06-30NoNoHistorical
85835-001-028583500010230 PATCH in 1 BOX (85835-001-02) 30 patch2025-06-30NoNoHistorical