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 52 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Neighbor Pharmacy Cold Therapy Pain Relief Patch MENTHOL Amerisource Bergen f872f371-b92c-f5d5-e053-6294a90a7dcd 2025-12-22 Warnings Exact identifier application number: M017 Caring Mills Hydrocortisone HYDROCORTISONE Veridian Healthcare b0b1889b-3099-4943-a4cb-d9a898a06860 2025-12-22 Warnings Exact identifier application number: M017 LIDOCAINE 5% LIDOCAINE Medhome Pharma Inc 46968f5a-d214-9871-e063-6394a90ab45d 2025-12-22 Warnings Exact identifier application number: M017 Blue-Emu THRIVE Cooling TRIPELENNAMINE 0.5% Kingsway Pharmaceuticals dba NFI, LLC 7ac6456a-42c5-4ac8-aae6-db4abfda9df0 2025-12-22 Warnings Exact identifier application number: M017 MENTHOL MENTHOL SUNSET PAIN RELIEF 45c5ca6f-d425-6cfb-e063-6394a90a1b66 2025-12-20 Warnings Exact identifier application number: M017 HERSTAT GST Genital Sore Treatment CAMPHOR, MENTHOL Herstat (USA) Inc. e8d27684-fb15-2e6a-e053-2a95a90a248f 2025-12-19 Warnings Exact identifier application number: M017 Kroger Anti Itch HYDROCORTISONE The Kroger Co 46547277-f11a-b9e7-e063-6294a90a2ccd 2025-12-19 Warnings Exact identifier application number: M017 Kroger Cool and Heat Roll-On MENTHOL Kroger 46551d07-3006-c3ec-e063-6294a90aa3f2 2025-12-19 Warnings Exact identifier application number: M017 Naughty Kitty Kat NO GAG DEEP THROAT SPRAY INKED SUGAR, INC 170eb644-c72c-5744-e063-6394a90a767d 2025-12-19 Warnings Exact identifier application number: M017 Tiger Balm Red Extra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. ce703715-4c11-472c-9270-daac87b7be05 2025-12-19 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Foot Pain Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. da82cc0e-cc39-408e-87e1-c35bb6f9f51e 2025-12-19 Warnings Exact identifier application number: M017 Health Trak Plus Menthol-Infused Pain Relief Socks MENTHOL Railroad Sock LLC 43413e55-1db2-fc1a-e063-6394a90a7167 2025-12-18 Warnings Exact identifier application number: M017 BIO-ICE MENTHOL, CAMPHOR Electrostim Medical Services Inc. d/b/a EMSI 1bfd1468-9139-43b1-9709-d47b63d17cfb 2025-12-18 Warnings Exact identifier application number: M017 Lidotrode LIDOCAINE Strand Health Group 1fd20b9a-b8bc-c94f-e063-6394a90a2b69 2025-12-18 Warnings Exact identifier application number: M017 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. ecf5decb-c98b-7739-e053-2995a90a5541 2025-12-18 Warnings Exact identifier application number: M017 After Burn 2.5% LIDOCAINE HCL Tender Corporation d/b/a Adventure Ready Brands 4640395f-a76c-d022-e063-6294a90adde6 2025-12-18 Warnings Exact identifier application number: M017 SPARTAN WIPES ENDURANCE WIPES TIV PRIME SRL 26d02431-2c95-001c-e063-6394a90a29c7 2025-12-18 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. a0f76968-d22c-4b1c-a9e6-8d0179a2e98e 2025-12-18 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LIDOCAINE HYDROCHLORIDE AND MENTHOL, KOBAYASHI Healthcare International, Inc. e364ff83-4aaf-4897-a7da-06581bc321f2 2025-12-18 Warnings Exact identifier application number: M017 Tiger Balm White Regular Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f406161e-a9c4-47d1-8b21-93b1b7938063 2025-12-17 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