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
MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength
30; .83 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Pain Relief Hot Patch
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1484488Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
110bcb16-ef0b-4bc8-8877-173a0494e1adAvailable on FDA.report

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

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 44 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
application number: M017
LIDOCAINE PAIN RELIEVING Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2159fb73-cf6c-184a-e063-6394a90a1d142026-01-08WarningsExact identifier
application number: M017
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0ca84-2800-d222-e053-2995a90ad8f32026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5b0db6-8f0a-4f8e-e053-2995a90a22b72026-01-08WarningsExact identifier
application number: M017
Capsaicin Topical AnalgesicCAPSAICINAvPAKef597423-cd01-7324-e053-2a95a90aa1ba2026-01-08WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINAvPAKef5a3846-1d2f-7023-e053-2a95a90ad7162026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5bb0fa-afc2-62d7-e053-2a95a90a37f42026-01-08WarningsExact identifier
application number: M017
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
application number: M017
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
application number: M017
Relieve A PainLIDOCAINERelieve A Pain LLCcafaa830-d894-4590-8928-d579cc791d792026-01-08WarningsExact identifier
application number: M017
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact identifier
application number: M017
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017

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