Capsaicin 0.025%
- Product NDC
- 80425-0541
- 11-digit product format
- 804250541
- Labeler code
- 80425
- Product ID
- 80425-0541_3bdcef9c-c018-f973-e063-6394a90a33c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin 0.025%
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-08
- Substance
- CAPSAICIN
- Active strength
- 2.5 mg/10g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 0.025%
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | 2.5 mg/10g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S07O44R1ZM | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043399 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3bdcef94-d06f-9152-e063-6294a90a6072 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0541-1 | Capsaicin 0.025% | 30 in 1 BOX | PATCH | 30 | 1 | |
| 80425-0541-1 | Capsaicin 0.025% | 10 g in 1 PATCH | PATCH | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0541-1 | EA - Each | 80425-0541 | 7e26495a-5001-4256-8eaa-ec77a2b81e6d | 1 | 2025-09-12 |
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 |
|---|---|---|---|---|---|---|
| HEEL PAIN Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 36bacb5f-c1af-2e97-e063-6394a90afe5c | 2025-06-04 | Warnings | M017 |
| Capsaicin 0.075% Cream | CAPSAICIN | ViolaCare, Inc. | 30911225-a6d7-4b2b-9005-b733373e2877 | 2025-06-04 | Warnings | M017 |
| LidoGuard | LIDOCAINE HCL | ViolaCare, Inc. | 531383aa-4f0f-4fe0-91f4-d809b39f160f | 2025-06-04 | Warnings | M017 |
| HealthWise Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Veridian Healthcare | 36c27642-f913-1aad-e063-6294a90a4343 | 2025-06-04 | Warnings | M017 |
| HealthWise Ultra OTC Strength Pain Relief Cream | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Veridian Healthcare | 36c3bbf9-a559-4c0d-e063-6394a90a8a1a | 2025-06-04 | Warnings | M017 |
| Everlight Survival Sting Relief Pad | BENZOCAINE | Yiwu Ori-Power Medtech Co.,Ltd. | 364c9882-339e-fe22-e063-6294a90a37f4 | 2025-06-04 | Warnings | M017 |
| LIGHTS Sting Relief Prep Pad | BENZOCAINE | Lights Medical Manufacture Co., Ltd. | 4f4d7758-be62-4304-8871-087a90497fa5 | 2025-06-04 | Warnings | M017 |
| Elsophie Nicotine Patches Quit | NICOTINE PATCHES QUIT SMOKING | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 36b63da9-94cc-b52a-e063-6394a90a5029 | 2025-06-03 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | M017 |
| RE-LEVE | MENTHOL | SOMBRA COSMETICS INC. | b4b39d79-0439-41e7-adca-e5ccb8f44e40 | 2025-05-29 | Warnings | M017 |
| PAIN NO MORE THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | f7bacc8e-6a8b-4cd8-bd0e-68890bee5818 | 2025-05-29 | Warnings | M017 |
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043399 | capsaicin 0.025 % Medicated Patch | PSN | 3bdcef94-d06f-9152-e063-6294a90a6072 | 1 |
| 1043399 | capsaicin 0.00025 MG/MG Medicated Patch | SCD | 3bdcef94-d06f-9152-e063-6294a90a6072 | 1 |
| 1043399 | capsaicin 0.025 % Medicated Patch | SY | 3bdcef94-d06f-9152-e063-6294a90a6072 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80425-0541-1 | 80425054101 | 30 PATCH in 1 BOX (80425-0541-1) / 10 g in 1 PATCH | 30 patch | 2025-08-08 | No | No | Current |