Home NDC 83613-411 ROPANA Pain Relief Cream
Product NDC 83613-411
11-digit product format 836130411
Labeler code 83613
Product ID 83613-411_09765451-b4c7-6a8d-e063-6294a90aa698
Type HUMAN OTC DRUG
Nonproprietary name HISTAMINE DIHYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler FUSION PAIN SOLUTIONS LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-21
Substance HISTAMINE DIHYDROCHLORIDE
Active strength .4 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 ROPANA Pain Relief Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTAMINE DIHYDROCHLORIDE .4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3POA0Q644U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2645121 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83613-411-00 ROPANA Pain Relief Cream 118 mL in 1 JAR CREAM 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83613-411 ROPANA PAIN RELIEF CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [FUSION PAIN SOLUTIONS LLC] 2 Current NDC, 1 package rows 20231106_e0342aa3-ca80-40b7-bec6-1b33c4db398b.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 89 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aloe Up SPF 50 Mineral ZINC OXIDE Aloe International, LLC 35bc3621-f4e4-42d3-e063-6394a90a7aad 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE, TITANIUM DIOXIDE Aloe Care International, LLC 35cd16b0-bd81-8f68-e063-6294a90a3d8c 2025-06-18 Warnings Exact identifier application number: M017 Aloe Up SPF 50 Kids Mineral ZINC OXIDE Aloe International, LLC 35cd5542-947d-a042-e063-6394a90a13f8 2025-06-18 Warnings Exact identifier application number: M017 Relieve Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra c12369dd-8305-edaf-e053-2995a90a0d3d 2025-06-18 Warnings Exact identifier application number: M017 Melt Pain Away CAPSAICIN Proximity Capital Partners LLC dba Asutra a95a11d7-a2ae-6654-e053-2a95a90a802c 2025-06-18 Warnings Exact identifier application number: M017 Recovery Roll-On MENTHOL, CAMPHOR PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA ebc9630f-6d8b-e4f0-e053-2995a90a0b49 2025-06-18 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37cdfabc-1fdb-246a-e063-6394a90a008a 2025-06-17 Warnings Exact identifier application number: M017 ProCure Hydrocortisone 1% HYDROCORTISONE Twin Med LLC 37ce6c35-b211-43de-e063-6294a90ab773 2025-06-17 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE CREAM 1% Sun Pharmaceutical Industries, Inc. 312ddc8d-100e-cfac-e063-6294a90acd09 2025-06-16 Warnings Exact identifier application number: M017 Curist 5% Lidocaine LIDOCAINE 5% Little Pharma, Inc. f20241a2-c5b1-f124-e053-2995a90a891b 2025-06-16 Warnings Exact identifier application number: M017 Toast Screamin Menthol MENTHOL IDEAZ, LLC 37b48b1a-ef3d-afdc-e063-6294a90a6610 2025-06-16 Warnings Exact identifier application number: M017 Toast Freezin Cold MENTHOL, METHYL SALICYLATE IDEAZ, LLC 37b4d363-0099-8cd3-e063-6394a90a18d6 2025-06-16 Warnings Exact identifier application number: M017 Earths Care Anti-Itch CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM DLC Laboratories, Inc. ba65f58a-d590-498a-b8e7-a3d78935d880 2025-06-13 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc 5eb6574c-2066-4390-befc-8e5d2dd6ede2 2025-06-12 Warnings Exact identifier application number: M017 CHINESE RED TIGER LIDOCAINE PATCHES 4% LIDOCAINE, 1%MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36b9a7a2-5832-4ce5-e063-6294a90aed12 2025-06-12 Warnings Exact identifier application number: M017 PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 375bc794-3289-e610-e063-6294a90a4f9b 2025-06-12 Warnings Exact identifier application number: M017 Methyl Salicylate 10% Pain Relieving METHYL SALICYLATE PureTek Corporation 376493eb-5142-db6d-e063-6294a90a1e73 2025-06-12 Warnings Exact identifier application number: M017 Free and Pure Cold Therapy Pain Relief MENTHOL Walgreen Co. 22cbbffc-f876-411e-e063-6394a90a1b38 2025-06-12 Warnings Exact identifier application number: M017 Methylten 25% Pain Relieving METHYL SALICYLATE PureTek Corporation 3767b97e-ab0c-ac26-e063-6394a90a00cf 2025-06-12 Warnings Exact identifier application number: M017 SPF 50 Mineral Sunscreen ZINC OXIDE Inspec Solutions, LLC 36af9a0a-536b-ee1a-e063-6394a90aace4 2025-06-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83613-411-00 83613041100 118 mL in 1 JAR (83613-411-00) 118 ml 2023-08-21 No No Current