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 |
|---|---|---|---|---|---|---|
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Advanced Rx of Tennessee, LLC | 44840250-2112-6ef4-e063-6394a90acdcc | 2026-06-12 | Warnings | M017 |
| DRAWYUM Pain Relief Gel-Patch | LIDOCAINE 4% PAIN RELIEF GEL-PATCH | Jiangxi Yudexi Pharmaceutical Co., LTD | 497e6e18-ba46-0001-e063-6294a90af026 | 2026-06-12 | Warnings | M017 |
| NATUHEAL JOINT BACK PAIN RELIEF | ARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEF | Jiangxi Yudexi Pharmaceutical Co., LTD | 4c923afa-4d1e-0776-e063-6294a90a2f54 | 2026-06-12 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | Aldermed Inc. | 4a7b532e-b292-b595-e063-6394a90acc9c | 2026-06-12 | Warnings | M017 |
| MG PLUS MENTHOL | MENTHOL | RENU LABORATORIES, LLC | 53737365-b985-3800-e063-6294a90a37f2 | 2026-06-11 | Warnings | M017 |
| CeraVe Developed with Dermatologists Itch Relief Moisturizing | PRAMOXINE HYDROCHLORIDE | L'Oreal USA Products Inc | 7c78d980-fc94-498c-aec5-464c0c76c8f4 | 2026-06-11 | Warnings | M017 |
| ANIXIKE Numbing | LIDOCAINE4% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a47f1ed-d8cf-3b0b-e063-6394a90a932a | 2026-06-11 | Warnings | M017 |
| Anti-Itch Soothing Wipes 1 Pramoxine Hydrochloride | PRAMOXINE HYDROCHLORIDE | The Honey Pot Company LLC | 81ab7fa7-d9b0-49dc-9782-02f37e588c5e | 2026-06-10 | Warnings | M017 |
| HealthWise Pain Relief Cream with Lidocaine | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | ef176d33-10b9-ddb2-e053-2995a90a76e3 | 2026-06-10 | Warnings | M017 |
| Warm Patch Tong Gu Huo Luo Gao | PAIN PATCH | Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory | 6906c4a0-1557-45e3-b915-80e4dd652ee7 | 2026-06-10 | Warnings | M017 |
| LidoMedix | LIDOCAINE, MENTHOL, CAMPHOR | Absolute Therapeutics, LLC | 53d504ef-eea3-6a47-e063-6394a90a1f65 | 2026-06-09 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | Preferred Pharmaceuticals Inc. | e51047da-8e17-4dd7-be3c-54820a7485f2 | 2026-06-09 | Warnings | M017 |
| Terramed Just Think Comfort GynoCare BV Guard Intimate Wash | PRAMOXINE HYDROCHLORIDE | Rida LLC | 09964550-049c-4c3b-817d-37e660c2e45c | 2026-06-08 | Warnings | M017 |
| Quality Choice Lidocaine Pain Relief Patch | LIDOCAINE | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | 526abe69-4bbc-6e73-e063-6394a90ad25d | 2026-06-08 | Warnings | M017 |
| Dcsily Numbing Cream | LIDOCAINE | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 53cab09c-6d5d-471e-e063-6294a90aa977 | 2026-06-08 | Warnings | M017 |
| Easment 0.1% Capsaicin cream for sensitive skin | CAPSAICIN 0.1% | Easment LLC | 537e0106-9e1c-66b8-e063-6294a90ac538 | 2026-06-05 | Warnings | M017 |
| Maximum Strength Pain Relief | MENTHOL CREAM | OWELL NATURALS LLC | 5388f2c5-8cfd-a601-e063-6294a90a2e5f | 2026-06-04 | Warnings | M017 |
| MG PLUS ROLL ON | MENTHOL ROLL ON | RENU LABORATORIES, LLC | 535dc42f-38c7-2afc-e063-6294a90ae23d | 2026-06-03 | Warnings | M017 |
| OP First Aid Series Insect Sting Relief Pad | BENZOCAINE, ISOPROPYL ALCOHOL | Yiwu Ori-Power Medtech Co.,Ltd. | b43af183-834a-0f64-e053-2995a90a3218 | 2026-06-03 | Warnings | M017 |
| PURE PRIMAL DELAY | LIDOCAINE HCL | Prodigy Media Inc | 1ddab664-7c44-452f-854f-e386cd69505e | 2026-06-03 | 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 |