FDA.reportPublic FDA data

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3

Product NDC
85831-035
11-digit product format
858310035
Labeler code
85831
Product ID
85831-035_45811e83-8d0c-bc2a-e063-6294a90adf50
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal Patches
Dosage form
PATCH
Route
TOPICAL
Labeler
PCHEERY LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-30
Substance
MENTHOL; NICOTINE
Active strength
.3; 6 g/1001; g/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
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.3 g/1001
NICOTINE6 g/1001

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
45811e83-8d0b-bc2a-e063-6294a90adf50Available 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
85831-035-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 31 in 1 PATCHPATCH11
85831-035-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 321 in 1 CARTONPATCH211

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 121 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra-Strength Pain Relief AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMTARGET CORPORATION159c5a84-bf68-41dd-a2d3-bc24020372442024-10-30WarningsExact identifier
application number: M017
DG Health Cold n Hot Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc8fe13b85-ab74-42f8-a664-d3d2959921ac2024-10-30WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewaybeefab66-b056-4bf1-b047-0780704ab87e2024-10-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEH E B15eb4676-5f6e-4c28-b5b9-4e45412dc37a2024-10-29WarningsExact identifier
application number: M017
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
application number: M017
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85831-035-018583100350121 PATCH in 1 CARTON (85831-035-01) / 1 PATCH in 1 PATCH21 patch2025-12-30NoNoCurrent