Capsaicin 0.035% cream
- Product NDC
- 82461-417
- 11-digit product format
- 824610417
- Labeler code
- 82461
- Product ID
- 82461-417_0371fc78-d964-4a3c-a2c3-7a1f6e8ad18a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medcore LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-04
- Substance
- CAPSAICIN
- Active strength
- .35 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Capsaicin 0.035% cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .35 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 577395 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0236e1e4-c26c-4fff-a83b-143ce26d93bf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82461-417-10 | Capsaicin 0.035% cream | 100 mL in 1 BOTTLE, PUMP | CREAM | 100 | 1 |
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 |
|---|---|---|---|---|---|---|
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 4a7f92d3-dd35-44a3-e063-6294a90ae004 | 2026-02-10 | Warnings | M017 |
| NICOVITO HEMORRHOID MASTER | LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5e24fa-959e-79b4-e063-6294a90a8f68 | 2026-02-09 | Warnings | M017 |
| Tiger Balm Active Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 2e7638c6-e1ce-4e2f-bd50-52fbce5a138e | 2026-02-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 2f272d12-7b34-430e-817e-1005f57ed9e9 | 2026-02-09 | Warnings | M017 |
| Welmate Lidocaine Pain Relieving Patch | LIDOCAINE | YYBA CORP | 4303fd30-0d35-3671-e063-6394a90a2aee | 2026-02-09 | Warnings | M017 |
| Pain Relief Lidocaine | LIDOCAINE | Kroger Company | 4098756e-3d9f-317a-e063-6394a90af04c | 2026-02-09 | Warnings | M017 |
| Aquanil HC | HYDROCORTISONE | Person and Covey | 4a698246-05a6-d01f-e063-6294a90a3401 | 2026-02-09 | Warnings | M017 |
| Hemorrhoid Master | LIDOCAINE, PHENYLEPHRINE | Ebanel Laboratories, Inc | 41292d65-dabe-4bc3-872f-34a3912aa342 | 2026-02-09 | Warnings | M017 |
| DERMFREE NEUROPATHY | ARNICA MONTANA 1X HPUS 7% NEUROPATHY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5c232d-5d29-2504-e063-6394a90ac9de | 2026-02-08 | Warnings | M017 |
| ASSIELF NUMBING Topical Anorectal | LIDOCAINE | Shenzhen Yuanbang International Logistics Co., Ltd | 4a5cb477-57ef-2a1d-e063-6394a90ac9ed | 2026-02-08 | Warnings | M017 |
| Lidocaine Pain Relieve Gel-Patch | PAIN RELIEVE GEL-PATCH | Henan Kangdi Medical Devices Co., Ltd | 1e31b950-e990-e255-e063-6394a90a7d23 | 2026-02-07 | Warnings | M017 |
| Herbal Knee Patch | HERBAL KNEE PATCH | Henan Kangdi Medical Devices Co., Ltd | 2a009059-b515-8214-e063-6294a90a4ed3 | 2026-02-07 | Warnings | M017 |
| Flocean ANTI-ITCH | BENZOCAINE 5%ANTI-ITCH | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a493911-a846-5aa0-e063-6294a90a65ac | 2026-02-07 | Warnings | M017 |
| daily solutions Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Garcoa, Inc. | 4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e6 | 2026-02-06 | Warnings | M017 |
| Lidocaine Pain Relief Gel-Patch | LIDOCAINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4a22562b-601e-97d7-e063-6394a90a5bca | 2026-02-06 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Sportpharm LLC | ee64ad1e-78db-4553-a3cf-b539b770fa26 | 2026-02-06 | Warnings | M017 |
| Pain Relief Gel-Patch | LIDOCAINE 4% | Sportpharm LLC | 1dd022b9-88ae-4737-88cc-fdb0ce0a83a3 | 2026-02-06 | Warnings | M017 |
| Camphor plus Lidocaine Pain Relief | CAMPHOR, LIDOCAINE | Veridian Healthcare | 4a2b73a8-c10c-85f9-e063-6294a90ac52c | 2026-02-06 | Warnings | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Retail Business Services, LLC | 073c72fe-3171-4a4f-913a-d1b9630a1af3 | 2026-02-06 | Warnings, Adverse reactions | M017 |
| HealthWise Soothing Lidocaine Pain Relief | LIDOCAINE HCI 0.5% | Veridian Healthcare | 4a2ec73e-7332-6f13-e063-6294a90a8506 | 2026-02-06 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577395 | capsaicin 0.035 % Topical Cream | PSN | 0236e1e4-c26c-4fff-a83b-143ce26d93bf | 1 |
| 577395 | capsaicin 0.35 MG/ML Topical Cream | SCD | 0236e1e4-c26c-4fff-a83b-143ce26d93bf | 1 |
| 577395 | capsaicin 0.035 % Topical Cream | SY | 0236e1e4-c26c-4fff-a83b-143ce26d93bf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 82461-417-10 | 82461041710 | 100 mL in 1 BOTTLE, PUMP (82461-417-10) | 100 ml | 2026-05-04 | No | No | Current |