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 |
|---|---|---|---|---|---|---|
| FL Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 | 2025-10-01 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | c7a7626c-cf82-4301-af79-c5e85367e777 | 2025-10-01 | Warnings | M017 |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | ViaDerma Distribution, Inc. | 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e | 2025-10-01 | Warnings | M017 |
| AsperFlex Advance | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | d23d7f2b-4dcd-4c31-9d12-340f233018b4 | 2025-10-01 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | 4024d604-c8c7-2d73-e063-6294a90a2e80 | 2025-10-01 | Warnings | M017 |
| DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl oz | MENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN) | BH GLOBAL HOLDINGS LLC | 1ddddbb6-2d01-c894-e063-6394a90acd58 | 2025-10-01 | Warnings | M017 |
| Tylenol Precise Pain Relieving Lidocaine 4% | LIDOCAINE | Kenvue Brands LLC | 36a95afd-97e5-2271-e063-6394a90aea18 | 2025-09-30 | Warnings | M017 |
| Capsaicin Heat | CAPSAICIN | Universal Distribution Center LLC | b3b40f77-3b0b-4111-968b-f3a87a5701fa | 2025-09-29 | Warnings | M017 |
| Caring Mills Menthol 4% Roll-On | MENTHOL | Veridian Healthcare | f4308c74-0860-4265-aeaf-a01301cca27a | 2025-09-29 | Warnings | M017 |
| COLD AND HOT MEDICATED LARGE | MENTHOL | Universal Distribution Center LLC | d6780230-aa96-4055-b054-be41358568b6 | 2025-09-29 | Warnings | M017 |
| COLD AND HOT MEDICATED | MENTHOL | Universal Distribution Center LLC | c19aa620-401d-43c4-804c-3611cc39e9f2 | 2025-09-29 | Warnings | M017 |
| UniShield First Aid Burn | LIDOCAINE HCL | Unishield | f729c557-da4b-3fb5-e053-6394a90a4196 | 2025-09-28 | Warnings | M017 |
| Xpect Hydrocortisone | HYDROCORTISONE | Cintas Corporation | 45ef9be4-54c4-4d85-966b-27708313ded4 | 2025-09-26 | Warnings | M017 |
| Zhuifeng Gao Pain Relieving | MENTHOL | GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD | 3f12da60-26d1-4407-8e02-c3213ea3ad2a | 2025-09-26 | Warnings | M017 |
| Gutong Tiegao Pain Relieving | MENTHOL | GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD | 5a5c3759-90e0-4a93-99cf-ddbf00aba10d | 2025-09-26 | Warnings | M017 |
| Zhuanggu Gao Pain Relieving | MENTHOL | GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD | e3e98530-ce4d-47b9-9383-3088814034eb | 2025-09-26 | Warnings | M017 |
| GUTONG TIEGAO PAIN RELIEVING | CAMPHOR AND MENTHOL | GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD | 3adfac16-ea7b-47df-89f5-91bbd09c4fe1 | 2025-09-26 | Warnings | M017 |
| Xpect Sting Wipes | BENZOCAINE 6% | Cintas Corporation | feeae00d-e266-4ae4-90d2-524da38fa813 | 2025-09-26 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Walgreens Company | 0b4053a8-6c1c-621d-e063-6394a90a4f56 | 2025-09-25 | Warnings | M017 |
| Unishield 1% | HYDROCORTISONE | Unishield | 4871a67f-fbb8-4a6b-ace4-d34349028908 | 2025-09-24 | 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 |