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 60 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
application number: M017
health beyondHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af2025-11-23WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDEDextrum Laboratories, Inc441daa6f-f273-ac09-e063-6394a90a252c2025-11-21WarningsExact 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