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 71 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coralite Pain Relief Hot MENTHOL AND CAPSAICIN United Exchange Corporation 78eb133d-01bb-6466-e053-2991aa0accc0 2025-10-23 Warnings Exact identifier application number: M017 Americaine BENZOCAINE Insight Pharmaceuticals LLC 4fd14452-0285-40c4-b835-36935c2056b2 2025-10-23 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bc1c0c-63d5-0d41-e063-6394a90a341b 2025-10-22 Warnings Exact identifier application number: M017 zourunan PAIN RELIEF PAIN RELIEF Guchutang Biotechnology (Longyan) Co., Ltd 41bd0769-6ba0-d0d5-e063-6294a90af7c9 2025-10-22 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Knee MENTHOL United Exchange Corp. aa5873bd-af64-41cc-8f16-7714c56bca96 2025-10-22 Warnings Exact identifier application number: M017 Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. 8e4d46d8-7084-0666-e053-2995a90ad520 2025-10-21 Warnings Exact identifier application number: M017 Coralite Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE United Exchange Corp. 69aec845-3d4c-d226-e053-2991aa0afd12 2025-10-21 Warnings Exact identifier application number: M017 WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE HOE HIN PAK FAH YEOW MANUFACTORY LTD f3e3b8b5-b12b-49ac-9318-b0c358b136e9 2025-10-21 Warnings Exact identifier application number: M017 Mountain Ice Sports Recovery MENTHOL Mountainside Medical Equipment, Inc. 98638529-3c17-436e-901f-c8aea52bdab6 2025-10-20 Warnings Exact identifier application number: M017 Lip Clear Lysine Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 21a5b4fb-baed-4766-9820-5c6051c14720 2025-10-20 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