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 75 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) aa6cc963-dc60-5222-e053-2995a90acaf6 2025-10-06 Warnings Exact identifier application number: M017 TheraCare 2% Diphenhydramine Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Veridian Healthcare 5999b677-63dd-49c6-b5b8-7b3c117ecc5c 2025-10-06 Warnings Exact identifier application number: M017 HealthWise Pain Relief MENTHOL Veridian Healthcare 06be5331-7a1e-4ab3-9f17-2d350bd4b890 2025-10-02 Warnings Exact identifier application number: M017 equate Burn Relief LIDOCAINE HYDROCHLORIDE Walmart Inc a90cbd92-80a5-4463-8152-b83165121a6f 2025-10-02 Warnings Exact identifier application number: M017 AsperFlex HOT CAMPHOR, MENTHOL, METHYL SALICYLATE Akron Pharma Inc. a6cb0656-8866-44ff-b40c-73655ff68721 2025-10-02 Warnings Exact identifier application number: M017 AsperFlex Original Maximum Strength MENTHOL Akron Pharma Inc. d766c61e-c48b-4aff-97b0-678159479e03 2025-10-02 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 1f9110da-f448-8e20-e063-6294a90a4275 2025-10-02 Warnings Exact identifier application number: M017 PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC dc704403-e2aa-47f7-a7f4-f6afe1547ca8 2025-10-01 Warnings Exact identifier application number: M017 PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC e02558a9-fe2b-4f28-9fd3-7308f859d759 2025-10-01 Warnings Exact identifier application number: M017 FL Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 2025-10-01 Warnings Exact identifier application number: M017 Carmex Classic Lip Balm Medicated CAMPHOR (SYNTHETIC), WHITE PETROLATUM Carma Laboratories, Inc. c7a7626c-cf82-4301-af79-c5e85367e777 2025-10-01 Warnings Exact identifier application number: M017 Viaderma Calm Anti-Itch HYDROCORTISONE ViaDerma Distribution, Inc. 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e 2025-10-01 Warnings Exact identifier application number: M017 AsperFlex Advance CAMPHOR, MENTHOL, METHYL SALICYLATE Akron Pharma Inc. d23d7f2b-4dcd-4c31-9d12-340f233018b4 2025-10-01 Warnings Exact identifier application number: M017 HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL SUNSET NOVELTIES, INC 4024d604-c8c7-2d73-e063-6294a90a2e80 2025-10-01 Warnings Exact identifier application number: M017 DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl oz MENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN) BH GLOBAL HOLDINGS LLC 1ddddbb6-2d01-c894-e063-6394a90acd58 2025-10-01 Warnings Exact identifier application number: M017 Tylenol Precise Pain Relieving Lidocaine 4% LIDOCAINE Kenvue Brands LLC 36a95afd-97e5-2271-e063-6394a90aea18 2025-09-30 Warnings Exact identifier application number: M017 Capsaicin Heat CAPSAICIN Universal Distribution Center LLC b3b40f77-3b0b-4111-968b-f3a87a5701fa 2025-09-29 Warnings Exact identifier application number: M017 Caring Mills Menthol 4% Roll-On MENTHOL Veridian Healthcare f4308c74-0860-4265-aeaf-a01301cca27a 2025-09-29 Warnings Exact identifier application number: M017 COLD AND HOT MEDICATED LARGE MENTHOL Universal Distribution Center LLC d6780230-aa96-4055-b054-be41358568b6 2025-09-29 Warnings Exact identifier application number: M017 COLD AND HOT MEDICATED MENTHOL Universal Distribution Center LLC c19aa620-401d-43c4-804c-3611cc39e9f2 2025-09-29 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