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 |
|---|---|---|---|---|---|---|
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3130729d-1679-90cd-e063-6294a90a21e6 | 2025-03-25 | Warnings | M017 |
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 31314dda-6199-574d-e063-6394a90aae7a | 2025-03-25 | Warnings | M017 |
| RWSEFK Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 31366793-f8a6-a2c4-e063-6294a90acbfc | 2025-03-25 | Warnings | M017 |
| Forticept Wounds and Burns Hydrogel | BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Lidan, inc. | c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f | 2025-03-25 | Warnings | M017 |
| MQ Pain Relieving Patch | PAIN RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0978ff22-c357-e266-e063-6394a90a98a4 | 2025-03-24 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Advanced Rx of Tennessee, LLC | 30c97646-db06-df84-e063-6394a90a7743 | 2025-03-20 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57 | 2025-03-20 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF | CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Carma Laboratories, Inc. | 5f904369-5f21-4907-98de-df23bce30823 | 2025-03-20 | Warnings | M017 |
| DermaCort Anti-itch | HYDROCORTISONE | Melaleuca, Inc. | 24044b0f-dd1e-4762-82b8-7a28b08c2f77 | 2025-03-20 | Warnings | M017 |
| AUVON Lidocaine Menthol Pain Relief Patch | LIDOCAINE AND MENTHOL | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 300cf469-5ca2-a40d-e063-6294a90a6801 | 2025-03-20 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 3a3af6e1-0281-462e-85e7-144cc5d46f32 | 2025-03-19 | Warnings | M017 |
| Lidocaine 4% | LIDOCAINE | Innovida Pharmaeutique Corporation | eb83a3dd-557e-4334-b806-5fc05e9175a3 | 2025-03-19 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | c04059e9-8175-46c2-8582-f84ef193abd3 | 2025-03-19 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 3a36a241-37a9-445a-a6e0-97709a7457a8 | 2025-03-19 | Warnings | M017 |
| Herb Analgesic | HERB ANALGESIC PASTE | Changsha Maocheng Trading Co., Ltd | 29373587-9eff-6ea0-e063-6394a90a23b2 | 2025-03-18 | Warnings | M017 |
| DEBACHERE Butt Balm After Play Care Multi Symptoms Relief | BENZOCAINE, BENZALKONIUM CHLORIDE | DE.BACHERE USA LLC | f469b446-58a0-4be3-884f-d622b9d074f8 | 2025-03-17 | Warnings | M017 |
| Auvon 4% Menthol Pain Relief Gel | MENTHOL | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 2dacd6fe-7d69-bcf0-e063-6294a90a0351 | 2025-03-14 | Warnings | M017 |
| Eagle Medicated | MENTHOL METHYL SALICYLATE | Borden Company (Private) Limited | 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84 | 2025-03-14 | Warnings | M017 |
| AY BENDITO THERMOACTIVE | MENTHOL, CAMPHOR | AY BENDITO INTERNATIONAL, INC | 304d71b6-91c8-b2b6-e063-6394a90ab669 | 2025-03-14 | Warnings | M017 |
| Hot/Cold Medicated Patch | HOT COLD PATCH | Dynarex | 999881b3-287e-d975-e053-2995a90a87e3 | 2025-03-14 | 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 |