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 |
|---|---|---|---|---|---|---|
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | ee8cd550-64ee-432e-98e5-b68083179a3c | 2026-01-05 | Warnings | M017 |
| REGENECARE HA | LIDOCAINE HCL | MPM Medical LLC | 0eee554f-dfe0-433a-9665-8bdb95229888 | 2026-01-05 | Warnings | M017 |
| Pain Relieving Cream | CAMPHOR AND MENTHOL | PAIN WIZARD LIMITED LIABILITY COMPANY | 2647bba1-87f4-3c16-e063-6394a90ae0c9 | 2026-01-05 | Warnings | M017 |
| TheraCare Lidocaine plus Menthol | LIDOCAINE, MENTHOL | Veridian Healthcare | efddd116-d753-425a-9ded-09b8045024e4 | 2026-01-05 | Warnings | M017 |
| TheraCare Original Menthol | MENTHOL | Veridian Healthcare | ea56e4e1-a758-428b-8758-ee31bb00ca82 | 2026-01-05 | Warnings | M017 |
| Mugwort Patch (Cervical spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e220c-0d35-9ee0-e063-6294a90ab689 | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Lumbar spine use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e4b21-6d81-4cd3-e063-6394a90a18fe | 2026-01-04 | Warnings | M017 |
| Mugwort Patch (Knee use) | 2%MENTHOL | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 478e86d2-3030-91eb-e063-6394a90a4db0 | 2026-01-04 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | 4a543f90-d43c-4487-b27e-f43394c6320d | 2026-01-04 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | 50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8 | 2026-01-02 | Warnings | M017 |
| Doctor Hoys Pain Relief Gel Roll-On | MENTHOL, CAMPHOR (SYNTHETIC) | Dynamic Blending Specialists, Inc. | bf47acb2-6c90-4d5c-820b-447cac9305a4 | 2026-01-02 | Warnings | M017 |
| Amino Rip Muscle Pain Relief | LIDOCAINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2bed5764-4217-4aa3-9d90-3b5460dcffa3 | 2026-01-02 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 63bb0283-cfbe-4e9c-8772-73062c0c8d05 | 2026-01-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Village Pharma LLC | 4c979a71-7c8f-4dff-abae-bf4cdf8f67b4 | 2026-01-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma LLC | ffb7831f-4ca9-4d73-8303-e9cd90078982 | 2026-01-01 | Warnings | M017 |
| Sting Relief | BENZOCAINE, ISOPROPYL ALCOHOL | Yiwu Ori-Power Medtech Co.,Ltd. | 116ee6dc-9c49-2e11-e063-6394a90a44ed | 2026-01-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Village Pharma LLC | 48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 5adf457e-b4d0-30c8-e063-6294a90a64b9 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | JC SALES | 490bc3b1-48bf-5437-e063-6394a90a9018 | 2026-01-01 | Warnings | M017 |
| NUVALU ICE THERAPY MENTHOL PAIN RELIEVING | MENTHOL | NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. | 5ae00308-0a8c-065c-e063-6394a90aff6b | 2026-01-01 | 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 |