FDA.reportPublic FDA data

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2

Product NDC
85831-034
11-digit product format
858310034
Labeler code
85831
Product ID
85831-034_4581acb1-bf23-13d7-e063-6394a90a60cf
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
NICOTINE; MENTHOL
Active strength
12; .3 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 2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE12 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
4580d7f0-92a9-d0d0-e063-6394a90ac393Available 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
85831-034-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 221 in 1 CARTONPATCH212
85831-034-01AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 21 in 1 PATCHPATCH12

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 126 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Anti ItchHYDROCORTISONEL. Perrigo Companyecd6d841-40b9-42c9-825d-d172cd04824d2024-10-03WarningsExact identifier
application number: M017
Gold Bond Medicated Original Strength BodyMENTHOLNavajo Manufacturing Company Inc.f71d598c-92c3-d6fd-e053-6394a90a97d72024-10-03WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafeway9e663535-4acc-4b37-acae-8c17517c5a3d2024-10-03WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLC849c60fc-e455-4c50-8adf-ac59c0ee785b2024-10-03WarningsExact identifier
application number: M017
rexall anti itch maximum strength reliefHYDROCORTISONEDolgencorp, LLC894cf9ab-693a-4210-96df-605947f51b632024-10-03WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85831-034-018583100340121 PATCH in 1 CARTON (85831-034-01) / 1 PATCH in 1 PATCH21 patch2025-12-30NoNoCurrent