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 |
|---|---|---|---|---|---|---|
| K19 RELIEF | MENTHOL | K19 LLC | e2e1ca96-1ae8-4c99-b8de-ce26754292f9 | 2025-01-15 | Warnings | M017 |
| Anecream | LIDOCAINE 4% | Focus Health Group | 2d7706e2-7363-4047-96cb-85b718277e8c | 2025-01-15 | Warnings | M017 |
| Boroleum | CAMPHOR, MENTHOL, WHITE PETROLATUM | Reliable 1 Laboratories | 846568af-0fdd-a80e-e053-2a91aa0a9c9e | 2025-01-15 | Warnings | M017 |
| LidoPro Pain Relief | CAPSAICIN AND LIDOCAINE | Advanced Rx of Tennessee, LLC | 27d5997b-1cc2-41c2-e063-6394a90ac74a | 2025-01-15 | Warnings | M017 |
| Pain Relief Patch 4% Lidocaine | LIDOCAINE | Reliable 1 Laboratories LLC | 2b624763-c310-63d9-e063-6394a90a1928 | 2025-01-15 | Warnings | M017 |
| Cannarelief 1000mg | MENTHOL | Carolina Cannabis Creations LLC | 01e2ae1a-c969-6dd2-e063-6394a90a9d9e | 2025-01-15 | Warnings | M017 |
| Healing Hand Cream 2000mg | MENTHOL | Carolina Cannabis Creations LLC | 01f8795b-9f95-c793-e063-6394a90a8330 | 2025-01-15 | Warnings | M017 |
| CBD Clinic Deep-Rub Pain Relief - Level 5 | CAMPHOR, MENTHOL | ABACUS HEALTH PRODUCTS, INC. | 31e2e5cd-d33e-f058-e063-6394a90af7d2 | 2025-01-14 | Warnings | M017 |
| Meijer Odor Free Analgesic Pain Relieving Topical Analgesic | LIDOCAINE HYDROCHLORIDE | Meijer Distribution, Inc | 6288efea-f636-4eea-bb9f-78aa2f9af54a | 2025-01-14 | Warnings | M017 |
| IKONIK TONIK | LIDOCAINE HYDROCHLORIDE | IKONIK CARE, LLC | 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 | 2025-01-14 | Warnings | M017 |
| elp essential MANTECA DE UBRE | METHYL SALICYLATE, CAMPHOR | Miramar Cosmetics, Inc DBA Miramar Lab | c3964dfe-17fe-4d89-a4c4-cf500f982259 | 2025-01-13 | Warnings | M017 |
| Methylten | METHYL SALICYLATE 10% | Puretek Corporation | 28f4093f-803f-0e70-e063-6294a90a98a4 | 2025-01-13 | Warnings | M017 |
| Refill Bundle 7 Large Office | BENZALKONIUM CHLORIDE | CMC Group, Inc. | 6620a8f3-098d-d045-e053-2a91aa0a0d94 | 2025-01-13 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba1de83-494a-6c54-e063-6294a90a9b2d | 2025-01-13 | Warnings | M017 |
| Arthritis Hot | MENTHOL AND METHYL SALICYLATE | Chattem, Inc. | cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd | 2025-01-13 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b40dda-53ad-0458-e063-6394a90aa835 | 2025-01-11 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 00b47eb7-6b43-d9e2-e063-6294a90a9a38 | 2025-01-11 | Warnings | M017 |
| Re-Lieved 4% Lidocaine Fabric Tape | LIDOCAINE 4% FABRIC TAPE | Transfer Technology | e9a894b0-54f2-707e-e053-2a95a90a0f0d | 2025-01-11 | Warnings | M017 |
| Re-Lieved 3 in 1 Patch | MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH | Transfer Technology | e9ab9a03-b9e3-7317-e053-2995a90a9950 | 2025-01-11 | Warnings | M017 |
| ASTRAPHARM CHILLI BRAND | CAPSAICIN | Dersan Pharmaceutical Co., Ltd | b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec | 2025-01-10 | 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 |