FDA.reportPublic FDA data

Nicotine Transdermal Patches

Product NDC
81799-001
11-digit product format
817990001
Labeler code
81799
Product ID
81799-001_f1e21df7-59c3-2245-e053-2995a90a82cf
Type
HUMAN OTC DRUG
Nonproprietary name
Aroamas Nicotine Transdermal Patches - Stop Smoking Aid
Dosage form
PATCH
Route
TOPICAL
Labeler
Ehy Holdings LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
MENTHOL; NICOTINE
Active strength
0 mg/100mg; mg/100mg
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81799-001-002024-07-30C16284748780-11030e365-2a15-111a-e063-dadaa90a10e281799-001 Nicotine Transdermal Patches
81799-001-012024-07-30C16284748780-11030e365-2a15-111a-e063-dadaa90a10e281799-001 Nicotine Transdermal Patches
81799-001-002024-01-30C16284748780-11030e365-2a15-111a-e063-dadaa90a10e281799-001 Nicotine Transdermal Patches
81799-001-012024-01-30C16284748780-11030e365-2a15-111a-e063-dadaa90a10e281799-001 Nicotine Transdermal Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81799-001-00Nicotine Transdermal Patches21 in 1 BOXPATCH213
81799-001-00Nicotine Transdermal Patches21 mg in 1 PATCHPATCH213
81799-001-01Nicotine Transdermal Patches21 mg in 1 PATCHPATCH213
81799-001-01Nicotine Transdermal Patches1 in 1 BOXPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81799-001NICOTINE TRANSDERMAL PATCHES (AROAMAS NICOTINE TRANSDERMAL PATCHES - STOP SMOKING AID) PATCH [EHY HOLDINGS LLC]3Legacy NDC, 4 package rows20230111_bf80e79b-f22f-5309-e053-2a95a90aee28.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81799-001-008179900010021 PATCH in 1 BOX (81799-001-00) > 21 mg in 1 PATCH21 patch2020-03-300000-00-00NoNoCurrent
81799-001-01817990001011 PATCH in 1 BOX (81799-001-01) > 21 mg in 1 PATCH1 patch2020-03-300000-00-00NoNoCurrent