FDA.reportPublic FDA data

Pain Relief Hot Patch

Product NDC
52000-046
11-digit product format
520000046
Labeler code
52000
Product ID
52000-046_fffe712b-e02a-4acd-8420-f0223244e0f7
Type
HUMAN OTC DRUG
Nonproprietary name
menthol and capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-23
Substance
CAPSAICIN; MENTHOL, UNSPECIFIED FORM
Active strength
.83; 30 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief Hot Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.83 mg/g
MENTHOL, UNSPECIFIED FORM30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A
Rxcui1484488

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-046-41Pain Relief Hot Patch8.5 g in 1 PATCHPATCH8.57
52000-046-41Pain Relief Hot Patch2 in 1 POUCHPATCH27
52000-046-42Pain Relief Hot Patch2 in 1 POUCHPATCH27
52000-046-42Pain Relief Hot Patch1 in 1 BOXPATCH17
52000-046-43Pain Relief Hot Patch24 in 1 BOXPATCH247
52000-046-43Pain Relief Hot Patch2 in 1 POUCHPATCH27

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1484488capsaicin 8.3 MG / menthol 30 MG in 1 GM Medicated PatchPSN110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 0.0083 MG/MG / menthol 0.03 MG/MG Medicated PatchSCD110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 0.83 % / menthol 3 % Medicated PatchSY110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 8.3 MG / menthol 30 MG per 1 GM Medicated PatchSY110bcb16-ef0b-4bc8-8877-173a0494e1ad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-046-41520000046412 PATCH in 1 POUCH (52000-046-41) / 8.5 g in 1 PATCH2 patch2024-12-02NoNoCurrent
52000-046-42520000046421 POUCH in 1 BOX (52000-046-42) / 2 PATCH in 1 POUCH / .206 g in 1 PATCH1 pouch2020-03-230000-00-00NoNoCurrent
52000-046-435200000464324 POUCH in 1 BOX (52000-046-43) / 2 PATCH in 1 POUCH / 8.5 g in 1 PATCH24 pouch2024-12-02NoNoCurrent