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 65 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.97345ed4-51c3-4221-852c-2cd563f333172025-11-12WarningsExact identifier
application number: M017
ZHENG GU SHUICAMPHOR, MENTHOLGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD17552943-4f11-42d6-ad41-fbc53f2bbd9a2025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.605fc242-ad31-4aa9-bd86-fba4ddf0d3052025-11-12WarningsExact identifier
application number: M017
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain ReliefMENTHOLTelebrands Corp95e84bb9-ba2e-5009-e053-2995a90a43622025-11-12WarningsExact identifier
application number: M017
LidozallLIDOCAINE HYDROCHLORIDEV2 Pharma LLC1eb2dfb2-3ad1-488b-aed9-17220e34a10c2025-11-12WarningsExact identifier
application number: M017
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
application number: M017
Knee Pain Relief PatchDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATEShenzhen Finona Information Technology Co., Ltd38755738-1a06-fdb4-e063-6294a90aa6eb2025-11-12WarningsExact identifier
application number: M017
Recovery NumbLIDOCAINE 4%PURKLENZ FORMULATIONS INC.e95e38e3-f743-4f5c-abdf-99ba6856e6f72025-11-12WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED434c13c2-52ee-000f-e063-6294a90af7e72025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED434d5f92-05c2-d884-e063-6394a90ad28c2025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434df0be-49ff-aa56-e063-6394a90a3b5a2025-11-11WarningsExact identifier
application number: M017
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
application number: M017
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
application number: M017
A and E Marathon Delay SerumDELAY SERUMPhe Inc4355d1d8-44fe-aca1-e063-6294a90a85ff2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
application number: M017
A and E Easy Anal GelANAL NUMBING LUBRICANTPhe Inc4355e0f3-65ba-eca6-e063-6394a90ab43c2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayPeppermintORAL NUMBING SPRAY MINTPhe Inc4355e0d0-1222-d594-e063-6294a90abb292025-11-11WarningsExact identifier
application number: M017
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
application number: M017
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact 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