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 87 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stopain Extra Strength MENTHOL Troy Manufacturing, Inc. 07e9a235-6d10-4407-8729-beaf936e97ad 2025-07-03 Warnings Exact identifier application number: M017 Blue Ice Topical Analgesic Gel ICE GEL International Wholesale 397cd306-078d-5b7d-e063-6294a90a8bbc 2025-07-03 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE, MENTHOL Vive Health LLC 236ccc6d-21b7-6153-e063-6394a90a4634 2025-07-02 Warnings Exact identifier application number: M017 AsperFlex MAX LIDOCAINE 4% WITH MENTHOL 1% Akron Pharma Inc. ccf6172b-350a-4b78-b844-f84bf17c491f 2025-07-02 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3766e3a9-94a8-4c3e-e063-6394a90aa24a 2025-07-01 Warnings Exact identifier application number: M017 Diphenhydramine Hydrochloride and Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Sun Pharmaceutical Industries, Inc. c89e3de8-7d71-485c-8fc5-2832d6024f16 2025-07-01 Warnings Exact identifier application number: M017 Westlake Outdoor Pain and Itch Relieving LIDOCAINE 4% PAIN AND ITCH RELIEVING WESTLAKE HB PHARMA 3c563b28-4f4f-9d0c-e063-6294a90adf73 2025-07-01 Warnings Exact identifier application number: M017 Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Exact identifier application number: M017 Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 38c1616e-3b09-0669-e063-6294a90a2c86 2025-06-29 Warnings Exact identifier application number: M017 Plantar Fasciitis Cream CAMPHOR SOLALIA LLC 388f33c2-2bdf-ded8-e063-6294a90aeeac 2025-06-27 Warnings Exact identifier application number: M017 4 Lidocaine Topical Anesthetic LIDOCAINE RUGBY LABORATORIES 63327e57-f4c8-4ae6-9d28-cef8697bbdcc 2025-06-27 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate ANTI-ITCH CONTINUOUS SPRAY Wal-Mart Stores, Inc. 709c3bb8-5b36-4823-941a-45ddb3e431c4 2025-06-27 Warnings Exact identifier application number: M017 Burn Relief Professional Bio-Kool LIDOCAINE - 4% Kool-Down Inc. 827e9c69-4706-0ccf-e053-2991aa0aa1c1 2025-06-27 Warnings Exact identifier application number: M017 Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017 SupreH Bee Venom Arthritis Pain Relieving Cream SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3876cc44-7f3a-b084-e063-6294a90a6142 2025-06-26 Warnings Exact identifier application number: M017 MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Exact identifier application number: M017 PHIZICO Pain Relief MENTHOL ER3 BRANDS INC. 72715dc5-d1e7-4b4b-8e28-4e367abba322 2025-06-25 Warnings Exact identifier application number: M017 Diva Cramp Care Cream METHYL SALICYLATE, MENTHOL, CAMPHOR Avaria Health & Beauty Corp 37368566-b14e-4d5c-bdde-6eea9073974f 2025-06-25 Warnings Exact identifier application number: M017 H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH LIDOCAINE HCL H2Ocean, LLC 386bf11b-1d71-44bf-e063-6394a90a2817 2025-06-25 Warnings Exact identifier application number: M017 Burn Relief Extra Strength Kool-Down LIDOCAINE - 3.9% Kool-Down Inc 827fec2f-db3c-adbb-e053-2a91aa0a7c17 2025-06-25 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