Home NDC 83591-417 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 Ingredient Strength MENTHOL 15 mg/mL CAPSAICIN .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup S07O44R1ZM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2583630 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83591-417-00 EMU THERAPY Red Hot Pepper Pain Relief Cream 237 mL in 1 JAR CREAM 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83591-417 EMU THERAPY RED HOT PEPPER PAIN RELIEF CREAM (MENTHOL, CAPSAICIN) CREAM [ACA MANAGEMENT LLC] 4 Current NDC, 1 package rows 20231106_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 48 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83591-417-00 83591041700 237 mL in 1 JAR (83591-417-00) 237 ml 2023-08-08 No No Current