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 |
|---|---|---|---|---|---|---|
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 359884d6-188a-e503-e063-6294a90acab4 | 2025-05-20 | Warnings | M017 |
| AY BENDITO - THERMOACTIVE | CAMPHOR, MENTHOL | AY BENDITO - THERMOACTIVE LOTION | 835abc66-680f-be06-e053-2a91aa0a309e | 2025-05-19 | Warnings | M017 |
| Numbing Cream | LIDOCAINE | 100 KARMA INC | 35884644-d017-eda3-e063-6394a90a1f6c | 2025-05-19 | Warnings | M017 |
| QUIT SMOKING Proven Patches | NICOTINE | Jiashen International Trade Limited | 35570155-c769-dc4c-e063-6394a90a019d | 2025-05-17 | Warnings | M017 |
| VBBV Tattoo Numbing | LIDOCAINE | Jiashen International Trade Limited | 3557859e-f8b3-1049-e063-6394a90ad737 | 2025-05-17 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 35415851-beba-5bb4-e063-6294a90a35c0 | 2025-05-16 | Warnings | M017 |
| Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 352798e1-1e09-3d47-e063-6394a90ad404 | 2025-05-15 | Warnings | M017 |
| Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 35285d62-c660-a056-e063-6294a90aabc8 | 2025-05-15 | Warnings | M017 |
| SionBiotext Hydrocortisone | HYDROCORTISONE ACETATE 1% | Sion Biotext Medical Ltd | 35073eae-26fe-2bb5-e063-6294a90ab56a | 2025-05-13 | Warnings | M017 |
| Bliss Republic Lidocaine Numbing Cream | LIDOCAINE NUMBING CREAM | Sargass Group Limited Liability Company | 3508ae14-d9c9-3c85-e063-6294a90a0098 | 2025-05-13 | Warnings | M017 |
| SORE NO MORE WARM THERAPY | MENTHOL AND CAMPHOR | SOMBRA COSMETICS INC. | cd86b56e-9b4c-4aca-9740-c8793cb12055 | 2025-05-12 | 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 |