Home NDC 85248-159-01 REINREUDE BACK PAIN THERAPY
Product NDC 85248-159
Requested package NDC 85248-159-01
11-digit product format 852480159
Labeler code 85248
Product ID 85248-159_5767284f-b3a9-a394-e063-6394a90a0c74
Type HUMAN OTC DRUG
Nonproprietary name Camphor 80mg Menthol 24mg Capsicum Extract 16mg BACK PAIN THERAPY
Dosage form PATCH
Route TOPICAL
Labeler Jiangxi Yudexi Pharmaceutical Co., LTD
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-10
Substance CAPSICUM; CAMPHORIC ACID; MENTHOL
Active strength 16; 80; 24 mg/1001; mg/1001; mg/1001
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
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 REINREUDE BACK PAIN THERAPY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSICUM 16 mg/1001 CAMPHORIC ACID 80 mg/1001 MENTHOL 24 mg/1001
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 00UK7646FG Internal UNII lookup 32K0C7JGCJ Internal UNII lookup L7T10EIP3A Internal UNII 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 85248-159-01 REINREUDE BACK PAIN THERAPY 10 in 1 BOX PATCH 10 1
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 78 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85248-159-01 85248015901 10 PATCH in 1 BOX (85248-159-01) 10 patch 2026-03-10 No No Current