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 93 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3304e362-dcda-3f5e-e063-6294a90a7015 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2f2f753d-c791-e863-e063-6394a90aec5d 2025-04-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 3162c96a-061d-2971-e063-6394a90a9b74 2025-04-29 Warnings Exact identifier application number: M017 Ivarest Poison Ivy Removal and Itch Relief PRAMOXINE HYDROCHLORIDE Blistex Inc. dedbf5d9-0f86-4f32-8321-da86c9838c0a 2025-04-29 Warnings Exact identifier application number: M017 HealthWise 2X Medicated Pain Relief Cream Roll-on MENTHOL Veridian Healthcare 33dae8a8-4197-f276-e063-6294a90aea83 2025-04-28 Warnings Exact identifier application number: M017 HealthWise Roll-on Menthol Pain Relief Gel MENTHOL Veridian Healthcare 33dbb939-9397-7e70-e063-6294a90ac8f4 2025-04-28 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. fa1a98bc-c233-410d-a20e-71111c897372 2025-04-28 Warnings Exact identifier application number: M017 Lidocaine Patch 4% LIDOCAINE 4% Medcore LLC b961906c-fe66-466b-af2c-072781fa098b 2025-04-28 Warnings Exact identifier application number: M017 Walgreens Lidocaine Knee and Elbow LIDOCAINE Walgreen Co. a3fb4c78-1493-4ba4-ae83-502dd825ed67 2025-04-25 Warnings Exact identifier application number: M017 Walgreens Lidocaine Back LIDOCAINE Walgreen Co. e6bfd342-c0db-46b9-b5e6-5acbd860adf1 2025-04-25 Warnings Exact identifier application number: M017 Electrum Numb Foam LIDOCAINE HCI RENU LABORATORIES, LLC c8472932-28b7-9189-e053-2a95a90a44df 2025-04-25 Warnings Exact identifier application number: M017 Benadryl Extra Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC 66a2fd60-1757-45cc-a195-ecb9241dca2a 2025-04-24 Warnings Exact identifier application number: M017 Jakwork Numbing Cream NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 3385cddb-609f-62e8-e063-6294a90add81 2025-04-24 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED LIDOCAINE, MENTHOL Compass Health Brands Corp. 2bd8aae0-2606-c7f2-e063-6294a90a9a20 2025-04-22 Warnings Exact identifier application number: M017 Mqforu Pain Patch PAIN PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 1f878abd-54cd-1963-e063-6294a90a1884 2025-04-22 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ON LIDOCAINE, MENTHOL Compass Health Brands Corp. 2c25fa5e-9546-ba74-e063-6294a90aadf4 2025-04-22 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALM LIDOCAINE, MENTHOL Compass Health Brands Corp. 2bd8cfb6-ab6c-9e04-e063-6294a90a2d52 2025-04-22 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Pharmheal 32e57c0f-d138-88dc-e063-6394a90ac085 2025-04-16 Warnings Exact identifier application number: M017 COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patch MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 32b7d73c-a191-7843-e063-6394a90aa631 2025-04-14 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE MARCELLA HEALTH 32c153c7-de30-504e-e063-6294a90a4020 2025-04-14 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