FDA.reportPublic FDA data

RBUGR QUIT SMOKING Nicotine Patches

Product NDC
87165-001
11-digit product format
871650001
Labeler code
87165
Product ID
87165-001_412d42c7-d383-20cc-e063-6294a90ae384
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH
Route
TOPICAL
Labeler
Nanjing Ludejin Corporation Management Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-15
Substance
MENTHOL; NICOTINE
Active strength
.003; .18 g/1; g/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
RBUGR QUIT SMOKING Nicotine Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.003 g/1
NICOTINE.18 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
6M3C89ZY6RInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
412d42c7-d382-20cc-e063-6294a90ae384Available on FDA.report

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
87165-001-01RBUGR QUIT SMOKING Nicotine Patches21 in 1 BOXPATCH211
87165-001-01RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11
87165-001-02RBUGR QUIT SMOKING Nicotine Patches42 in 1 BOXPATCH421
87165-001-02RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11
87165-001-03RBUGR QUIT SMOKING Nicotine Patches60 in 1 BOXPATCH601
87165-001-03RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RBUGR QUIT SMOKING Nicotine PatchesNICOTINENanjing Ludejin Corporation Management Co., Ltd412d42c7-d382-20cc-e063-6294a90ae3842025-10-15WarningsExact identifier
ndc (product): 87165-001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87165-001-018716500010121 PATCH in 1 BOX (87165-001-01) / 1 PATCH in 1 PATCH21 patch2025-10-15NoNoCurrent
87165-001-028716500010242 PATCH in 1 BOX (87165-001-02) / 1 PATCH in 1 PATCH42 patch2025-10-15NoNoCurrent
87165-001-038716500010360 PATCH in 1 BOX (87165-001-03) / 1 PATCH in 1 PATCH60 patch2025-10-15NoNoCurrent