FDA.reportPublic FDA data

EMU THERAPY Red Hot Pepper Pain Relief Cream

Product NDC
83591-417
11-digit product format
835910417
Labeler code
83591
Product ID
83591-417_09760958-f963-2465-e063-6294a90a0278
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
ACA MANAGEMENT LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-08
Substance
MENTHOL; CAPSAICIN
Active strength
15; .25 mg/mL; mg/mL
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
EMU THERAPY Red Hot Pepper Pain Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL15 mg/mL
CAPSAICIN.25 mg/mL

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
2583630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36293885-b2dd-4fba-9748-35a3c9e05078Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83591-417-00EMU THERAPY Red Hot Pepper Pain Relief Cream237 mL in 1 JARCREAM2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83591-417EMU THERAPY RED HOT PEPPER PAIN RELIEF CREAM (MENTHOL, CAPSAICIN) CREAM [ACA MANAGEMENT LLC]4Current NDC, 1 package rows20231106_36293885-b2dd-4fba-9748-35a3c9e05078.zip

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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2583630capsaicin 0.025 % / menthol 1.5 % Topical CreamPSN36293885-b2dd-4fba-9748-35a3c9e050784
2583630capsaicin 0.25 MG/ML / menthol 15 MG/ML Topical CreamSCD36293885-b2dd-4fba-9748-35a3c9e050784
2583630capsaicin 0.025 % / menthol 1.5 % Topical CreamSY36293885-b2dd-4fba-9748-35a3c9e050784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83591-417-0083591041700237 mL in 1 JAR (83591-417-00) 237 ml2023-08-08NoNoCurrent