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 77 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ink Scribd Numbing LIDOCAINE HCL Prodigy Media Inc 54173858-aff0-43b2-bc7b-c4ecab9bc3e5 2025-09-17 Warnings Exact identifier application number: M017 Inkorporated Numbing LIDOCAINE HCL Prodigy Media Inc 3017056c-f3c6-4300-8344-bf6e7d32e870 2025-09-17 Warnings Exact identifier application number: M017 TattooGirl Numbing LIDOCAINE HCL Prodigy Media Inc 6abe4540-f6c9-412a-83f3-682df7715057 2025-09-17 Warnings Exact identifier application number: M017 Dr Tatty Numbing LIDOCAINE HCL Prodigy Media Inc 5bb558c1-bf8f-4956-8732-e19720f62f31 2025-09-17 Warnings Exact identifier application number: M017 Burn Ease Cooling LIDOCAINE ProStat First Aid LLC ec201ca1-efa0-4797-aec3-115647c29abd 2025-09-17 Warnings Exact identifier application number: M017 MedFreeze Naturally Cool Pain Relief MENTHOL MEDKO LLC 240f2346-c585-4334-997c-45db6268d7c4 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK DUAL HOT AND COLD METHYL SALICYLATE, MENTHOL Natureteq Inc. ba5f4626-f077-4a28-8dcc-dacd50741ead 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK ICE MENTHOL, CAMPHOR Natureteq Inc. c1077744-7b9a-4536-8faf-e21994a43ea5 2025-09-15 Warnings Exact identifier application number: M017 Caring Mills Vaginal Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare cd379e74-2841-47e4-b95a-de1b341b397f 2025-09-15 Warnings Exact identifier application number: M017 Lidocaine-Pain-Relief-Patch LIDOCAINE-PAIN-RELIEF-PATCH Henan Enokon Medical Instrument Co., Ltd. 3ecfa867-50f6-d98a-e063-6394a90aefa0 2025-09-14 Warnings Exact identifier application number: M017 Meijer Hydrocortsione Cream HYDROCORTSIONE CREAM 1% Meijer Distribution Inc. 1cbddb7e-f2e3-0951-e063-6394a90a3d37 2025-09-12 Warnings Exact identifier application number: M017 JO Prolonger with Benzocaine BENZOCAINE CC Wellness LLC d955f612-1267-f1be-e053-2995a90a5345 2025-09-12 Warnings Exact identifier application number: M017 JO for Him Prolonger with Lidocaine LIDOCAINE CC Wellness LLC b12dc6a3-142d-3219-e053-2995a90aead0 2025-09-12 Warnings Exact identifier application number: M017 Walgreens Medicated Foot Powder MENTHOL Davion, Inc 58e1e7f7-6284-411f-9765-0e63eabca0f3 2025-09-12 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Amerisource Bergen 614f1e56-891f-4620-be10-0c075a1dbc3f 2025-09-11 Warnings Exact identifier application number: M017 Industrial Itch and Pain Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE R & R Lotion, Inc 236415fc-f923-4a82-b54a-ecaf666dd2e0 2025-09-11 Warnings Exact identifier application number: M017 Eco Lips Menthol Medicated Lip Balm MENTHOL Eco Lips, Inc. fc4c25d6-6109-dfd8-e053-6394a90a4e91 2025-09-10 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE 1% Encube Ethicals, Inc. d6f5c0df-6262-4704-bb24-430f66bb2ca8 2025-09-09 Warnings Exact identifier application number: M017 Blue-Emu Lidocaine Pain Relief Cream LIDOCAINE CREAM 4% Kingsway Pharmaceuticals dba NFI, LLC 592811f2-e21c-6a58-e053-2991aa0a69a9 2025-09-09 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Unifirst First Aid Corporation 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 2025-09-09 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