Capsaicin 0.035 Percent
- Product NDC
- 50488-1035
- 11-digit product format
- 504881035
- Labeler code
- 50488
- Product ID
- 50488-1035_e2a30b7f-bcde-4a77-bcbd-3e965d4f8004
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alexso, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-01
- Substance
- CAPSAICIN
- Active strength
- .035 g/100g
- 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 Percent
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .035 g/100g |
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 |
|---|---|
| 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50488-1035-1 | Capsaicin 0.035 Percent | 120 g in 1 BOTTLE | CREAM | 120 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-1035-1 | GM - Gram | 50488-1035 | 41964388-d8a5-429d-8c3a-dccbbb9de672 | 1 | 2026-04-20 |
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 |
|---|---|---|---|---|---|---|
| LidoTape | LIDOCAINE 4% | V2 Pharma LLC | ed18b4f7-6a2c-4dce-9b53-e485569093c5 | 2026-04-09 | Warnings | M017 |
| TheraCare Lidocaine Pain Relief | LIDOCAINE | Veridian Healthcare | 4f112ab2-b67a-a3e2-e063-6394a90acb60 | 2026-04-09 | Warnings | M017 |
| TheraCare Pain Relief | MENTHOL | Veridian Healthcare | 4f11aa1e-de53-a3b0-e063-6294a90a2fe4 | 2026-04-09 | Warnings | M017 |
| TheraCare 2X Medicated Pain Relief | LIDOCAINE, MENTHOL | Veridian Healthcare | 4f11fca1-1949-ab8e-e063-6394a90ac627 | 2026-04-09 | Warnings | M017 |
| TheraCare Medicated Pain Relief | CAMPHOR, MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 4f125062-af89-40d3-e063-6394a90a27ef | 2026-04-09 | Warnings | M017 |
| DRMITSUI ECZEMA RELIEF | HYDROCORTISONE 1% ECZEMA RELIEF | Jiangxi Yudexi Pharmaceutical Co., LTD | 4eee7637-3a28-e0bd-e063-6294a90ae1a4 | 2026-04-08 | Warnings | M017 |
| SINSIN MULPAS | L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR | Sinsin Pharmaceutical Co., Ltd. | 47c077c2-6e34-8e7a-e063-6294a90a21b5 | 2026-04-08 | Warnings | M017 |
| Yi Tiao Gen Pain Patch | PAIN PATCH | Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory | 4828fe70-f6f8-45e4-9c9a-a9e486dc65e5 | 2026-04-07 | Warnings | M017 |
| Dermatool Nerve Care | LIDOCAINE HCL, MENTHOL | Papalo Group, LLC | 4ee40c96-9350-4c68-e063-6294a90ac812 | 2026-04-07 | Warnings | M017 |
| Burn Relief | LIDOCAINE | CVS Pharmacy, Inc. | 42b3c341-f422-b2b4-e063-6294a90a47b2 | 2026-04-06 | Warnings | M017 |
| KinetiCream Pain Relieving Topical Analgesic | MENTHOL | Phoenix Bioperformance Products LLC | bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7 | 2026-04-06 | Warnings | M017 |
| KinetiCream Anti-Inflammatory and Pain Relief | MENTHOL | Phoenix Bioperformance Products LLC | 39a6d26b-b5f4-45d7-a9b5-6edbf42d7500 | 2026-04-06 | Warnings | M017 |
| Dr. Blue PainZaway Pain Relieving Roll-On | MENTHOL | Indiana Botanic Gardens | 4ecc8241-5a87-2f45-e063-6294a90aa30a | 2026-04-06 | Warnings | M017 |
| Sunburn Relief Gel | LIDOCAINE HCL | CVS Pharmacy, Inc. | d7f52394-5cc1-48a6-ae89-9fc63b515758 | 2026-04-06 | Warnings, Adverse reactions | M017 |
| Pain-Relieving Patch | CAMPHOR, MENTHOL, METHYL SALICYLATE | CVS Pharmacy | 4ecf4a6e-5c0f-7943-e063-6394a90a81cc | 2026-04-06 | Warnings | M017 |
| RAPID RELIEF | 0.025% CAPSAICIN PAIN PATCH | RAPID AID VIET NAM COMPANY LIMITED | 4edbaa1a-6e44-4865-e063-6394a90a8cc3 | 2026-04-06 | Warnings | M017 |
| Capsaicin 0.1% Cream | CAPSAICIN 0.1% | Puretek Corporation | 4e83441b-cb6a-beb0-e063-6394a90a1b54 | 2026-04-03 | Warnings | M017 |
| NeroCare Capsaicin Neuropathy Relief Cream | CAPSAICIN | Guangzhou Tata Biotechnology Co., Ltd. | 4e89b7eb-0d84-dc57-e063-6394a90a7dd9 | 2026-04-03 | Warnings | M017 |
| TheraCare Pain Relief Patch | LIDOCAINE 4% | Veridian Healthcare | 4e91da65-8191-6261-e063-6394a90a6bd5 | 2026-04-03 | Warnings | M017 |
| HealthWise Roll-On | LIDOCAINE, MENTHOL | Veridian Healthcare | 4e9306b5-949e-f7a9-e063-6394a90ae13a | 2026-04-03 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577395 | capsaicin 0.035 % Topical Cream | PSN | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
| 577395 | capsaicin 0.35 MG/ML Topical Cream | SCD | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
| 577395 | capsaicin 0.035 % Topical Cream | SY | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50488-1035-1 | 50488103501 | 120 g in 1 BOTTLE (50488-1035-1) | 120 g | 2025-09-01 | No | No | Current |