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 Relief Patch | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Shenzhen Finona Information Technology Co., Ltd | 38755738-1a06-fdb4-e063-6294a90aa6eb | 2025-11-12 | Warnings | M017 |
| Recovery Numb | LIDOCAINE 4% | PURKLENZ FORMULATIONS INC. | e95e38e3-f743-4f5c-abdf-99ba6856e6f7 | 2025-11-12 | Warnings | M017 |
| Rapid Relief | COLD RELIEF PATCH 5% MENTHOL | RAPID AID VIET NAM COMPANY LIMITED | 434c13c2-52ee-000f-e063-6294a90af7e7 | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG | RAPID AID VIET NAM COMPANY LIMITED | 434d5f92-05c2-d884-e063-6394a90ad28c | 2025-11-11 | Warnings | M017 |
| Rapid Relief | PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1% | RAPID AID VIET NAM COMPANY LIMITED | 434df0be-49ff-aa56-e063-6394a90a3b5a | 2025-11-11 | Warnings | M017 |
| TopCare Pain Relief Maximum Strength | LIDOCAINE HYDROCHLORIDE | TOPCO ASSOCIATES | b0ae3a7c-52d1-4923-bd50-6bb3749006c8 | 2025-11-11 | Warnings | M017 |
| Comfortcaine | LIDOCAINE HCL | QS Key West Aloe, LLC | 831b7c11-e437-4e74-808e-c9c1eb8b82f6 | 2025-11-11 | Warnings | M017 |
| A and E Marathon Delay Serum | DELAY SERUM | Phe Inc | 4355d1d8-44fe-aca1-e063-6294a90a85ff | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayStrawberry | ORAL NUMBING SPRAY STRAWBERRY | Phe Inc | 4355dab1-a293-ded6-e063-6394a90af9b0 | 2025-11-11 | Warnings | M017 |
| A and E Easy Anal Gel | ANAL NUMBING LUBRICANT | Phe Inc | 4355e0f3-65ba-eca6-e063-6394a90ab43c | 2025-11-11 | Warnings | M017 |
| A and E Deep Throat Desensitizing SprayPeppermint | ORAL NUMBING SPRAY MINT | Phe Inc | 4355e0d0-1222-d594-e063-6294a90abb29 | 2025-11-11 | Warnings | M017 |
| DermaNumb Analgesic | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 0ea46890-45c3-4732-bc47-227f7c67daf1 | 2025-11-11 | Warnings | M017 |
| Derma Numb Pain Relief | LIDOCAINE HCL | A.T.S. Laboratories, LLC | 710991ae-8f82-4893-93a7-0ef3f815d132 | 2025-11-11 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | Encube Ethicals, Inc. | 969cd576-82d3-4662-bbc1-3587a1f6a564 | 2025-11-10 | Warnings | M017 |
| Jelcaine Sterile | LIDOCAINE HCL JELLY USP, 2% | Brookfield Pharmaceuticals, LLC | 1a39d1de-7aa2-3068-e063-6394a90aed85 | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | c6e86a0f-6f9b-45b7-86ce-0bb1c198061a | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | 97ae1993-7268-4b7f-92e2-6004337d5650 | 2025-11-10 | Warnings | M017 |
| MENTHOL AND METHYL SALICYLATE | ELECTRIC MEDICATED BALM ULTRA STRENGTH | FEI FAH MEDICAL MANUFACTURING PTE LTD | 91e6d3b9-25bb-4015-9d96-bd27f93e5ada | 2025-11-10 | Warnings | M017 |
| E MEI SHAN MEDICATED | CAMPHOR, MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | bda1e7c1-42df-4126-a512-80f843b07fd0 | 2025-11-10 | Warnings | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEVING | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | 9850754b-ac94-4ec6-b75a-8096e5ac9456 | 2025-11-10 | Warnings, Adverse reactions | 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 |