FDA.reportPublic FDA data

Flobow QUIT SMOKING Nicotine

Product NDC
85248-012
11-digit product format
852480012
Labeler code
85248
Product ID
85248-012_495b10ce-3d2e-1aa4-e063-6294a90a4f35
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
2026-01-27
Substance
NICOTINE; MENTHOL
Active strength
18; .3 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

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
Flobow QUIT SMOKING Nicotine
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
495b10ce-3d2d-1aa4-e063-6294a90a4f35Available 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
85248-012-01Flobow QUIT SMOKING Nicotine21 in 1 BOXPATCH211

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 135 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ralli Rapid Pain Relief Roll onMENTHOLTroy Manufacturing, Inc.978d5c2c-fdc4-4d25-83ec-0b9404ec80182024-02-19WarningsExact identifier
application number: M017
11681168 BURN SPRAYDynarex Corporation1183a4f5-f875-dfb0-e063-6394a90af35f2024-02-16WarningsExact identifier
application number: M017
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
application number: M017
No Mess Hydrocortisone ApplicatorHYDROCORTISONEWalgreen Co.cfefb517-9099-41c4-8a95-74414ca4032c2024-02-16WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpab9bf09d-bc8c-6d17-e053-2995a90a6c362024-02-14WarningsExact identifier
application number: M017
Natures Oil 16% MentholMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.2fbe23b7-23a3-4f0b-bc08-0205256f5d682024-02-14WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATERugby Laboratories4c11876c-57ec-4429-a8c4-fb95baa4074a2024-02-13WarningsExact identifier
application number: M017
Itch stopping CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.11368823-d4af-a536-e063-6294a90a7a2e2024-02-12WarningsExact identifier
application number: M017
Walgreens Boil Pain ReliefBOIL PAIN RELIEFWalgreens Companyd11bd769-68d0-4057-bc2a-72719f16011e2024-02-12WarningsExact identifier
application number: M017
CapsaicinCAPSAICINRugby Laboratoriesc5915c84-84a2-46f6-9f97-0d9873e9944a2024-02-12WarningsExact identifier
application number: M017
Leader Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADER952e56ea-5cbc-4078-bd01-5d3b6864a5ce2024-02-09WarningsExact identifier
application number: M017
Leader Ultra Strength Muscle Rub Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATECardinal Health, 110 dba LEADER9d99a900-60e0-454c-98e0-2c63eb910cf12024-02-09WarningsExact identifier
application number: M017
Pain RelievingCAMPHOR (NATURAL)J.R. Watkins, LLC.28821ffa-a138-47b5-8857-beadf7a20d432024-02-08WarningsExact identifier
application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic RubCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.fd0ea70a-ef12-48b1-8d9d-cc5f6417f8542024-02-08WarningsExact identifier
application number: M017
Pain Relieving CoolingMENTHOL, UNSPECIFIED FORMJ.R. Watkins, LLC.3574d48a-b546-4ea7-b470-071bb328de642024-02-08WarningsExact identifier
application number: M017
Advil Targeted ReliefCAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATEHaleon US Holdings LLC16e6be21-7b43-443a-89ec-3bdf0ec0dfc12024-02-08WarningsExact identifier
application number: M017
POINT RELIEF COLD SPOT Pain RelievingMENTHOLFABRICATION ENTERPRISES96f1d592-6cec-412e-a5fd-cf3c4f68644f2024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
application number: M017
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-012-018524800120121 PATCH in 1 BOX (85248-012-01) 21 patch2026-01-27NoNoCurrent