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 |
|---|---|---|---|---|---|---|
| ItchZap | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rising Pharma Holdings, Inc. | 245d0afb-19a8-4cfb-968b-d892b18d5f2c | 2025-11-06 | Warnings | M017 |
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | ba6c7e97-d740-484b-8711-55fa7ab15784 | 2025-11-04 | Warnings | M017 |
| China-Gel | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, Inc. | d7c5cb17-f7a2-7f57-e053-2995a90a40f7 | 2025-11-04 | Warnings | M017 |
| Aulief Topical Pain Reliever | MENTHOL AND CAMOHOR | China-Gel, LLC | 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | 254abae9-ef1b-5a90-e054-00144ff88e88 | 2025-11-04 | Warnings | M017 |
| Pain Relief Gel-Tube | MENTHOL | Bullet point LLC | 42c93789-9758-54b7-e063-6394a90ac398 | 2025-11-04 | Warnings | M017 |
| Tattoo care | TATTOO CARE CREAM | Perfso (HK) Co., Limited | 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 | 2025-11-04 | Warnings | M017 |
| CORE RELIEF | CAMPHOR, MENTHOL | Copper Joint, LLC | 42d17270-f58d-9d69-e063-6294a90a4078 | 2025-11-04 | Warnings | M017 |
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Marcella Health | d25f25ee-79f8-49e7-9715-0aae305b73e5 | 2025-11-03 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE 5% | YYBA Corp | 1319ee69-8b3f-5815-e063-6294a90a5ad5 | 2025-11-03 | Warnings | M017 |
| Goodsense Extra Strength Cold and Hot Medicated | MENTHOL | Geiss, Destin and Dunn, Inc. | 7585d111-775f-4fb6-a485-28cd99d88852 | 2025-10-31 | Warnings | M017 |
| Topcare Cold and Hot Medicated | MENTHOL | Topco Associates LLC | 8739aedd-165c-5ae0-e053-2a91aa0afcd0 | 2025-10-31 | Warnings | M017 |
| CVS Medicated Heat 1 ct | CAPSAICIN | CVS Pharmacy, Inc. | d41dce5b-e698-4930-8869-040b2a973f25 | 2025-10-31 | Warnings | M017 |
| Coralite Medicated Heat | CAPSAICIN | United Exchange Corp. | a0b89c7e-80bc-43c4-840c-5fd567f60b21 | 2025-10-31 | Warnings | M017 |
| Dragon with Arnical Pain Relief | MENTHOL | Genomma Lab USA Inc. | b4cbb7b6-cb71-9721-e053-2995a90a2b2c | 2025-10-31 | Warnings | M017 |
| Gemachlich ZuHause NEUROPATHY SOLID Ointment. | GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. | Guangdong Quadrant Ecological Technology Co., Ltd. | 425b1b9d-c33a-05e9-e063-6394a90a97a6 | 2025-10-30 | Warnings | M017 |
| Gemachlich ZuHause NEUROPATHY Spray. | GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. | Guangdong Quadrant Ecological Technology Co., Ltd. | 425b8259-af38-8d68-e063-6394a90a1120 | 2025-10-30 | Warnings | M017 |
| Family Care Muscle and Joint | MENTHOL | United Exchange Corp. | 959af9f4-7188-91a1-e053-2995a90a4665 | 2025-10-30 | 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 |