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 |
|---|---|---|---|---|---|---|
| Stallion | DELAY CREME | Novelties by Nasswalk, Inc. | 0261ec88-8fe4-d5f8-e063-6294a90ab3d4 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03b89eed-b433-a263-e063-6294a90a675b | 2025-11-10 | Warnings | M017 |
| Instant Erection | ULTIMATE ERECTION ENHANCER | Novelties by Nasswalk, Inc. | 03a444f9-7052-0c38-e063-6294a90a4e56 | 2025-11-10 | Warnings | M017 |
| STA-HARD | DESENSITIZING LUBRICANT | Novelties by Nasswalk, Inc. | 02ef794b-8e70-5c26-e063-6294a90a28d1 | 2025-11-10 | Warnings | M017 |
| ANAL-ESE | DESENSITIZER | Novelties by Nasswalk, Inc. | 03a4a7ce-4cff-a608-e063-6294a90ad65d | 2025-11-10 | Warnings | M017 |
| FOOTSPA PEDI | ALCOHOL | CHEMCO CORPORATION | 04de4392-74f6-7df8-e063-6294a90ae3b1 | 2025-11-08 | Warnings | M017 |
| Johnson and Johnson All Purpose First Aid Kit | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 5cdb47c5-7951-4279-8a05-0a3199d3dd45 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid Travel Ready 80 CT | ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f388f105-48ba-4616-e053-2a95a90a0049 | 2025-11-06 | Warnings | M017 |
| Johnson and Johnson First Aid All Purpose 160 CT | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f3933330-2550-4a88-e053-2a95a90a3997 | 2025-11-06 | Warnings | M017 |
| Foot and Leg Pain Relief | LIDOCAINE | Premier Brands of America Inc. | 42f23e2f-11c6-da49-e063-6294a90ac720 | 2025-11-06 | Warnings | M017 |
| HEALING TREE CALMING ANTI-ITCH | HYDROCORTISONE | Renu Laboratories, LLC | fc8bcde9-26e8-a35f-e053-6394a90a3300 | 2025-11-06 | Warnings | M017 |
| Calamine Plus | CALAMINE PLUS PRAMOXINE HCL | Chain Drug Marketing Association Inc | 1a3f8819-58cf-8923-e063-6394a90a37af | 2025-11-06 | Warnings | M017 |
| Extra Strength Itch Relief | DIPHENHYDRAMINE HCL AND ZINC ACETATE | Chain Drug Marketing Association Inc | 1a2997bc-7741-e658-e063-6394a90af6fd | 2025-11-06 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY | Topco Associates LLC | 8026c7dd-eb7b-ebea-e053-2991aa0a1b0f | 2025-11-06 | Warnings | M017 |
| Diphenhydramine HCl and Zinc Acetate | EXTRA STRENGTH ITCH RELIEF | Walgreen Company | 6057b4ff-6adc-4688-893c-62d237d7d1ae | 2025-11-06 | Warnings | M017 |
| BANPINGHUA Glucosamine Chondroitin Patch | PEPPERMINT, CAMPHOR, BORNEOL | Henan Lijitang Medical Technology Co., Ltd. | 42f8c2ae-50a2-2358-e063-6394a90a5979 | 2025-11-06 | Warnings | M017 |
| PAINGEL | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fa2397-b61a-3b16-e063-6294a90a5fed | 2025-11-06 | Warnings | M017 |
| PAINGEL UNGUENTO | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fab525-b0a5-97fb-e063-6394a90aec6c | 2025-11-06 | Warnings | M017 |
| PAINGEL ROLL-ON | MENTHOL | NACOR BUSINESS GROUP LLC | 42fb0bdf-8bbd-bbe3-e063-6294a90a656c | 2025-11-06 | Warnings | M017 |
| Coolexa | CAMPHOR, MENTHOL, METHYL SALICYLATE | Rising Pharma Holdings, Inc. | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 2025-11-06 | 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 |