FDA.reportPublic FDA data

Pain Relief Patch

Product NDC
83559-005
11-digit product format
835590005
Labeler code
83559
Product ID
83559-005_31c724bc-ecbd-fd1a-e063-6294a90a686d
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relief Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Henan Enokon Medical Instrument Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-07
Substance
CAMPHOR (SYNTHETIC); CAPSICUM; MENTHOL
Active strength
80; 16; 24 mg/1001; mg/1001; mg/1001
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)80 mg/1001
CAPSICUM16 mg/1001
MENTHOL24 mg/1001

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, 00UK7646FG, L7T10EIP3A
Rxcui853132

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83559-005-01Pain Relief Patch5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83559-005PAIN RELIEF PATCH PATCH [HENAN ENOKON MEDICAL INSTRUMENT CO., LTD.]2Current NDC, 1 package rows20250406_1592d29d-e275-a44d-e063-6294a90ab17d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853132camphor 80 MG / capsicum 16 MG / menthol 24 MG Medicated PatchPSN1592d29d-e275-a44d-e063-6294a90ab17d2
853132camphor 80 MG / Capsicum extract 16 MG / menthol 24 MG Medicated PatchSCD1592d29d-e275-a44d-e063-6294a90ab17d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83559-005-01835590005015 PATCH in 1 BOX (83559-005-01) 5 patch2024-04-07NoNoCurrent