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 |
|---|---|---|---|---|---|---|
| good sense anti itch | HYDROCORTISONE | L. Perrigo Company | b7a896cc-1d78-45c0-a73e-aa1e117f7d3b | 2024-09-29 | Warnings | M017 |
| Topcare Hydrocortisone | HYDROCORTISONE | Topco Associates LLC | b7362f21-f1a3-4edc-b5b6-a16680e05df3 | 2024-09-29 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | H E B | 412ca2d1-064b-4438-aee1-fcb5cf27c7db | 2024-09-29 | Warnings | M017 |
| Topcare Antibiotic | NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 8c349cac-20e1-4600-9b0a-fcfe929551c5 | 2024-09-26 | Warnings | M017 |
| good sense anti itch | HYDROCORTISONE | A-S Medication Solutions | 072dd455-24a5-4a44-aaef-d3e137d005a6 | 2024-09-26 | Warnings | M017 |
| SYREN Intimate Relief | LIDOCAINE HYDROCHLORIDE | Icon Health Science | 57d5a080-3583-4510-e053-2a91aa0ad589 | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | f4db90ad-dd62-44f1-9655-2614ed36581e | 2024-09-25 | Warnings | M017 |
| AOSI HEALTHCARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a28b920c-0bb8-4b5a-addd-26ea164e036e | 2024-09-25 | Warnings | M017 |
| anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Kroger Company | 067e718a-ec0b-4895-8f9f-82d64ab4c7b4 | 2024-09-24 | Warnings | M017 |
| topcare anti itch | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Topco Associates LLC | e0fb332a-2903-41ef-b35b-7cd3a74cff99 | 2024-09-24 | Warnings | M017 |
| equaline anti itch | HYDROCORTISONE | United Natural Foods, Inc. dba UNFI | 83cd9f60-a4c4-4dea-97a7-cd96aade9e88 | 2024-09-24 | Warnings | M017 |
| good sense itch relief | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | L. Perrigo Company | 162fe0a3-3995-4e6f-94ed-f839b2b0c80e | 2024-09-24 | Warnings | M017 |
| Caring Mill Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 22ca137a-576c-a13c-e063-6394a90ae7fc | 2024-09-23 | Warnings | M017 |
| Signature Care Anti Itch | HYDROCORTISONE | Safeway | ed0eb068-3ce6-423d-a7f8-c3456b7f6040 | 2024-09-23 | Warnings | M017 |
| members mark hydrocortisone | HYDROCORTISONE | Sam's West Inc | 218f0dcd-fa67-4935-8019-ecbbd53ed2f7 | 2024-09-23 | Warnings | M017 |
| anti itch | HYDROCORTISONE | Meijer, Inc. | a07496e0-6fc2-4190-8a01-f513134ffb92 | 2024-09-23 | Warnings | M017 |
| ZYLOTROL PAIN RELIEVING | LIDOCAINE HCL, MENTHOL | Whitestone Products LLC | 2301fed7-0fa9-450d-8b1b-006f53235be0 | 2024-09-21 | Warnings | M017 |
| Tibetree Cheezheng Joint Analgesic Patch | CAMPHOR | Tibet Cheezheng Tibetan Medicine Co. Ltd | 65a8a63f-1864-473e-be72-7840a6a5dee7 | 2024-09-20 | Warnings | M017 |
| Cold Ice Analgesic Gel | MENTHOL | Dabur India Limited | 22915b2f-5f76-3e38-e063-6394a90a07b4 | 2024-09-20 | Warnings | M017 |
| Exchange Select Hydrocortisone | HYDROCORTISONE | Army & Air Force Exchange Service | 1b709db3-7dc1-4756-a8a0-dddda875dc57 | 2024-09-19 | 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 |