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 |
|---|---|---|---|---|---|---|
| SORE NO MORE COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 | 2025-05-12 | Warnings | M017 |
| Calm and Correct Serum with Lidocaine | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | ddcf1c2e-2f67-44d7-e053-2a95a90a812b | 2025-05-09 | Warnings | M017 |
| Mqupin Knee Patch | KNEE PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 09772e4b-8193-3771-e063-6394a90a9516 | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | d57a59fb-c8f2-f73b-e053-2995a90a4cdb | 2025-05-08 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 4c96ec41-841c-322b-e054-00144ff8d46c | 2025-05-08 | Warnings | M017 |
| GNP Extra Strength Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Amerisource Bergen | 34a66224-ef3c-e36e-e063-6394a90ac99d | 2025-05-08 | Warnings | M017 |
| Good Neighbor Muscle Rub Cream | CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%, | Amerisource Bergen | 34924bb9-e3e8-70e6-e063-6294a90aaa8c | 2025-05-07 | Warnings | M017 |
| DermaRad Relief Post Radiation Calming | LIDOCAINE 3 PERCENT | Renu Laboratories, LLC | e5d64929-fb9c-7ebc-e053-2995a90a9318 | 2025-05-07 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee0235-5a6e-0ea1-e063-6394a90a89a5 | 2025-05-06 | Warnings | M017 |
| DermaRad Relief | LIDOCAINE EMULSION | RENU LABORATORIES, LLC | d5e11f73-918b-eeac-e053-2995a90a4a83 | 2025-05-06 | Warnings | M017 |
| Plantar Fasciitis Pain Relief Gel-Patch | LIDOCAINE, MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 34838622-b092-afeb-e063-6294a90ae7db | 2025-05-06 | Warnings | M017 |
| Climax Shield Delay | BENZOCAINE | PRODUCT MAX GROUP INC | 9c720cdc-f753-47ce-95ff-3b26e461a0ab | 2025-05-05 | Warnings | M017 |
| PediFix Lidocaine Pain-Relief Patches | LIDOCAINE PAIN-RELIEF PATCHES | PediFix, Inc | 346550b9-d2ba-184e-e063-6394a90a591a | 2025-05-05 | Warnings | M017 |
| Walgreens Stop Itch Gel | DIPHENHYDRAMINE HCL | Walgreens Co | 23586336-8f46-3dcd-e063-6394a90accc9 | 2025-05-04 | Warnings | M017 |
| WaxRx EarAcheRx Pain Relieving Drops | 4% LIDOCAINE HCL | DOCTOR EASY MEDICAL PRODUCTS, LLC | 34156655-8706-f0a4-e063-6294a90acc90 | 2025-05-01 | Warnings | M017 |
| foster and thrive anti itch cream | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Strategic Sourcing Services LLC | bb08293d-5db8-4cc8-9fe3-bd02061dbeb9 | 2025-04-30 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch | LIDOCAINE | Solis Pharmaceuticals Inc. | 3061d301-2104-b1b2-e063-6394a90a9b6e | 2025-04-29 | Warnings | M017 |
| Maximum Strength 4% Lidocaine Patch | LIDOCAINE | InterMed Laboratories Private Limited | 33ed754e-8852-d5b2-e063-6394a90a7cf2 | 2025-04-29 | Warnings | M017 |
| Cold Hot Medicated Patch 5% Menthol | MENTHOL | InterMed Laboratories Private Limited | 33ee6e48-243e-4ded-e063-6394a90a987d | 2025-04-29 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Guangzhou Zhupuyou E-commerce Co., Ltd | 32b96689-8e9b-4c2e-e063-6294a90a7d1c | 2025-04-29 | 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 |