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 |
|---|---|---|---|---|---|---|
| Active Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3a9f9ca0-3d8a-796a-e063-6394a90a790c | 2025-08-01 | Warnings | M017 |
| Active Recovery Pain Relief Stick | CAMPHOR, MENTHOL | Charlottes Web, Inc. | 3aa037c6-6109-b52e-e063-6394a90a215b | 2025-08-01 | Warnings | M017 |
| PM Recovery Pain Relief | CAMPHOR, MENTHOL | Charlotte's Web, Inc. | 3aa08859-809d-de8c-e063-6394a90a8e25 | 2025-08-01 | Warnings | M017 |
| Wish ultra winter ice | MENTHOL | LJ Pharma | b4c5487c-1314-4d63-96df-077e72e7ee95 | 2025-08-01 | Warnings | M017 |
| Rugged Fit Pain Relief Roll On | MENTHOL, METHYL SALICYLATE | SYSTEM4BOOK LLC | 39d68734-981c-14d7-e063-6294a90a4919 | 2025-08-01 | Warnings | M017 |
| ICY FREEZE | MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 28fdb049-b297-4358-9447-7d69ba879702 | 2025-08-01 | Warnings | M017 |
| Cortizone 10 Cooling | HYDROCORTISONE | Chattem, Inc. | 14d9fce2-9f54-4204-83cb-161de8a303f0 | 2025-08-01 | Warnings | M017 |
| Bravado Labs Numbing | LIDOCAINE HCL | Prodigy Media Inc | 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 | 2025-07-30 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3721c984-1993-6265-e063-6394a90af23f | 2025-07-29 | Warnings | M017 |
| Chimera GUARD | LIDOCAINE PAIN RELIEFING PATCH | Hangzhou Rongna Health Technology Co., Ltd. | 3758d625-010f-7441-e063-6394a90a066d | 2025-07-29 | Warnings | M017 |
| Cold Therapy Roll on | COLD THERAPY ROLL ON | Allegiant Health | 36463acb-7c28-416f-a45f-a93f0be5692b | 2025-07-29 | Warnings | M017 |
| ProCure Anti Itch | CAMPHOR 0.5% | Twin Med LLC | 3afe387c-ef42-215d-e063-6394a90a41b5 | 2025-07-28 | Warnings | M017 |
| lidocaine pain relief patches | LIDOCAINE | Changsha Maocheng Trading Co., Ltd | 3afeead3-4f5c-4711-e063-6294a90aacca | 2025-07-28 | Warnings | M017 |
| SYNC ICE | SYNC RELIEF ICE | iON Pharma, LLC | 38ce98ce-a7bf-8041-e063-6394a90ae730 | 2025-07-28 | Warnings | M017 |
| SYNC PRO | SYNC RELIEF PRO CREAM | iON Pharma, LLC | 3a3e91d6-732b-dca9-e063-6394a90a06d4 | 2025-07-28 | Warnings | M017 |
| Careland Pain Relief | METHYL SALICYLATE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd. | 83f36771-1033-4fd0-a0e6-82c1dcfedeee | 2025-07-28 | Warnings | M017 |
| Rite Aid anti-itch | HYDROCORTISONE | Rite Aid Corporation | 2a232dd1-9071-4c55-a7f7-19d8404b99a6 | 2025-07-28 | Warnings | M017 |
| Hydrocortisone Plus 12 Moisturizers | HYDROCORTISONE | RITE AID CORPORATION | 05598255-3e7a-46a5-ae7e-dcfcb616d59d | 2025-07-28 | Warnings | M017 |
| Inked Inspired | LIDOCAINE HCL | Prodigy Media Inc | 54fb2860-7e63-4598-953a-170226e613e9 | 2025-07-28 | Warnings | M017 |
| Ujhay Hydrocortisone Ointment. | UJHAY HYDROCORTISONE OINTMENT | Guangdong Quadrant Ecological Technology Co., Ltd. | 3af59276-8e6a-0603-e063-6394a90a1f9b | 2025-07-27 | 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 |