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 |
|---|---|
| HISTAMINE DIHYDROCHLORIDE | .4 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3POA0Q644U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2645121 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e0342aa3-ca80-40b7-bec6-1b33c4db398b | Available on FDA.report |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| KNEE PAIN RELIRF Patch | CAMPHOR, MENTHOL | Shenzhen Finona Information Technology Co., Ltd | 3db971ef-d7fa-0171-e063-6294a90aa58b | 2025-09-01 | Warnings | M017 |
| Bikini Zone Medicated Creme | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 300ac57e-844a-4840-b285-41ff5518e6b6 | 2025-08-29 | Warnings | M017 |
| Bikini Zone Medicated Gel | LIDOCAINE | Kingsway Pharmaceuticals dba NFI, LLC | 30b85890-e72d-4af7-bda9-e7744abc92af | 2025-08-29 | Warnings | M017 |
| Sumifun Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 3d7dc8cc-0680-d94d-e063-6394a90ac8e8 | 2025-08-29 | Warnings | M017 |
| TKTALKER NUMBING | NUMBING | Shenzhen Shandian Jingling Technology Co., Ltd. | 3d7e6757-f183-2a68-e063-6294a90ae4ca | 2025-08-29 | Warnings | M017 |
| PBZ OTC | TRIPELENNAMINE HCL 1% | Kingsway Pharmaceuticals dba NFI, LLC | 12f72d74-018f-4bc6-acd4-175ca3af4c6d | 2025-08-29 | Warnings | M017 |
| else. | LIDOCAINE | Else Co. | 3d6c7b10-ed03-bbde-e063-6294a90ae92f | 2025-08-28 | Warnings | M017 |
| Mountain Ice Pain Relief | MENTHOL | Mountainside Medical Equipment, Inc. | c79fdd91-16f4-4ae0-bee4-d37c05ed2074 | 2025-08-28 | Warnings | M017 |
| HealthWise 4% Lidocaine Cream 2.7 oz | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | f39eb3d0-e153-4f50-85b1-ad5c677d176c | 2025-08-28 | Warnings | M017 |
| HealthWise Overnight Menthol Patch | MENTHOL | Veridian Healthcare | 6379f50d-2878-46ca-8acb-71c4554585e9 | 2025-08-28 | Warnings | M017 |
| Anti Itch Maximum Relief | PRAMOXINE HYDROCHLORIDE AND MENTHOL | Natureplex LLC | 75de3d5e-ecbe-4d04-a39d-792200e6ee32 | 2025-08-28 | Warnings | M017 |
| NicDuic Quit Smoking Nicotine Patches | NICOTINE TRANSDERMAL PATCHES | Shenzhen Paxi Trading Co., Ltd. | 3d5718f3-c175-6b64-e063-6394a90aa6f1 | 2025-08-27 | Warnings | M017 |
| ARCTIC HEAT | MENTHOL, METHYL SALICYLATE | Renu Laboratories, LLC | 402df5c1-b8cb-17a2-e054-00144ff8d46c | 2025-08-27 | Warnings | M017 |
| PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE | HYDROCORTISONE | Click Industries LLC | 328c389c-7e05-4892-a9b3-b6a753f4935a | 2025-08-25 | Warnings | M017 |
| Yeheal | CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL | Shenzhen Yeheal Biotechnology Co., Ltd | 3cf1bc74-3060-6d63-e063-6294a90a9f5c | 2025-08-22 | Warnings | M017 |
| Dermedial Anti-Ouch | MENTHOL | Natures Formulae Health Products Ltd. | 3ce29160-3964-e435-e063-6394a90abb38 | 2025-08-21 | Warnings | M017 |
| SUGARLOAF ORGANICS MENTHOL REVIVE | MENTHOL | RENU LABORATORIES, LLC | fa2f9539-b703-a00b-e053-6394a90ae309 | 2025-08-21 | Warnings | M017 |
| Camphor 4% Plus Menthol 10% | CAMPHOR 4% PLUS MENTHOL 10% | PureTek Corporation | 3cab26e4-e377-f26a-e063-6394a90a17af | 2025-08-20 | Warnings | M017 |
| Capsaicin 0.035% Cream | CAPSAICIN 0.035% CREAM | Puretekcorp | 3cbc73b6-8c58-8f23-e063-6394a90a71a3 | 2025-08-20 | Warnings | M017 |
| Game On | MENTHOL, METHYL SALICYLATE | Natural Essentials, Inc. | 3cd20f1f-033f-f698-e063-6294a90a89eb | 2025-08-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2645121 | histamine dihydrochloride 0.04 % Topical Cream | PSN | e0342aa3-ca80-40b7-bec6-1b33c4db398b | 2 |
| 2645121 | histamine dihydrochloride 0.4 MG/ML Topical Cream | SCD | e0342aa3-ca80-40b7-bec6-1b33c4db398b | 2 |
| 2645121 | histamine dihydrochloride 0.04 % Topical Cream | SY | e0342aa3-ca80-40b7-bec6-1b33c4db398b | 2 |
Packages#
| 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 |