FDA.reportPublic FDA data

WOFANLI Quit Smoking Nicotine Patches

Product NDC
85835-009
Requested package NDC
85835-009-01
11-digit product format
858350009
Labeler code
85835
Product ID
85835-009_41426d44-863b-dbec-e063-6394a90aab5c
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
2025-10-16
Substance
NICOTINE
Active strength
21 mg/1001
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
WOFANLI Quit Smoking Nicotine Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/1001

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41427275-4c35-bbdf-e063-6294a90a14cfAvailable 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
85835-009-01WOFANLI Quit Smoking Nicotine Patches30 in 1 BOXPATCH301

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 105 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAdvanced Rx of Tennessee, LLC0b7736df-c7e0-7d00-e063-6294a90aa57e2024-12-31WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
application number: M017
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving CreamLIDOCAINE, MENTHOLSato Pharmaceutical Co., Ltd.2251e96b-d050-4ec2-a6b9-6659610885bf2024-12-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESafewayaf2e2ef3-0f3f-4592-8081-b6553ade2f5a2024-12-26WarningsExact identifier
application number: M017
Comforte Menstrual Cramp Relief CreamMENTHOLPMS4PMS LLCc121537e-3333-4f35-8c77-20086158dff42024-12-26WarningsExact identifier
application number: M017
N-Labs Arcticzen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNUTRIOMO LABS PTE. LTD05ee574a-854c-4a77-be77-082055075c4d2024-12-26WarningsExact identifier
application number: M017
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
application number: M017
GNP Anti ItchCAMPHOR, MENTHOLAMERISOURCEBERGEN DRUG CORPORATIONb4f2d6f7-2287-47d8-e053-2995a90ae3352024-12-23WarningsExact identifier
application number: M017
cool and heat pain relieving liquidMENTHOLBionpharma Inc.ec6f59d8-45c5-46a0-e053-2995a90a239f2024-12-23WarningsExact identifier
application number: M017
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
application number: M017
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
application number: M017
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN41427275-4c35-bbdf-e063-6294a90a14cf1
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN41427275-4c35-bbdf-e063-6294a90a14cf1
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN41427275-4c35-bbdf-e063-6294a90a14cf1
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD41427275-4c35-bbdf-e063-6294a90a14cf1
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD41427275-4c35-bbdf-e063-6294a90a14cf1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD41427275-4c35-bbdf-e063-6294a90a14cf1
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198029nicotine 14 MG/Day 24HR Transdermal SystemSY41427275-4c35-bbdf-e063-6294a90a14cf1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY41427275-4c35-bbdf-e063-6294a90a14cf1
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY41427275-4c35-bbdf-e063-6294a90a14cf1
198031nicotine 7 MG/Day 24HR Transdermal SystemSY41427275-4c35-bbdf-e063-6294a90a14cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85835-009-018583500090130 PATCH in 1 BOX (85835-009-01) 30 patch2025-10-16NoNoCurrent