FDA.reportPublic FDA data

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
IngredientStrength
CAPSICUM16 mg/1001
CAMPHORIC ACID80 mg/1001
MENTHOL24 mg/1001

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00UK7646FGInternal UNII lookup
32K0C7JGCJInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ca7d0ca-6407-1fed-e063-6394a90aacccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-159-01REINREUDE BACK PAIN THERAPY10 in 1 BOXPATCH101

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 72 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Muscle and Joint Pain ReliefCAPSACINUnited Exchange Corp.ba9a3d72-db7a-4dd0-9220-f43c9ed871142025-10-21WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
application number: M017
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.375bfe83-c895-3ea7-e054-00144ff88e882025-10-18WarningsExact identifier
application number: M017
Advanced Healing Diabetic Skin CareDIMETHICONEEco-Logics, Inc.c6704d06-0311-406e-98a7-b8c8881aefd52025-10-18WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.378d1109-6511-1f63-e054-00144ff88e882025-10-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-159-018524801590110 PATCH in 1 BOX (85248-159-01) 10 patch2026-03-10NoNoCurrent