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 |
|---|---|---|---|---|---|---|
| XtraCare Ice Cold Topical Analgesic Gel | MENTHOL | Rejoice International | d38f3099-d940-44d8-aa7f-404157c5e0e3 | 2023-10-24 | Warnings | M017 |
| Family Wellness | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | fefbe351-1cd9-4a2f-a43d-51e2c4eb180b | 2023-10-24 | Warnings | M017 |
| TheraPlus Plus | MENTHOL | Zhejiang Jingwei Pharmaceutical Co., Ltd. | d4119f84-eb60-4134-b58e-de13d9601199 | 2023-10-24 | Warnings | M017 |
| Family Wellness | HYDROCORTISONE | Zhejiang Jingwei Pharmaceutical Co., Ltd. | cddc9c4a-7c58-4225-921a-05d6afb49178 | 2023-10-24 | Warnings | M017 |
| NUMOTIZINE | MENTHOL | Hobart Laboratories, Inc. | 9a29ad1b-4ba3-403f-90c9-ee7582fe4535 | 2023-10-20 | Warnings | M017 |
| Numfast Tetracaine Green | TETRACAINE | Unit Dose, Ltd. | 77d9e6ea-1cd3-4447-ba74-01cd7143e27c | 2023-10-19 | Warnings | M017 |
| Liprotek | PETROLATUM, LIDOCAINE | Unit Dose, Ltd. | 051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5 | 2023-10-19 | Warnings | M017 |
| GENUINE FIRST AID Antiseptic Pain Relieving | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | bc7c6739-6068-4694-adc9-0c0c5c347df4 | 2023-10-19 | Warnings | M017 |
| CVS Itch relief moisturizing | PRAMOXINE HCL 1% | CVS Health | f3a753fc-f448-6bba-e053-2a95a90a8e1b | 2023-10-18 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Asclemed USA, Inc. | e13984ea-73a9-2894-e053-2995a90a8ed6 | 2023-10-16 | Warnings | M017 |
| EXOTEN-C | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Asclemed USA, Inc. | 76ed37e0-64b5-4abe-a03c-3dc7084a3919 | 2023-10-16 | Warnings | M017 |
| Calypxo Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6 | 2023-10-16 | Warnings | M017 |
| Calypxo HP Pain Relief | METHYL SALICYLATE, MENTHOL | Asclemed USA, Inc | 89a8c267-bd92-4d0d-8e50-c52224aff9cd | 2023-10-16 | Warnings | M017 |
| Zylotrol | LIDOCAINE HCL 4%, MENTHOL 1% | Whitestone Products LLC | 0e32e9c0-ff5b-4e88-89b1-f5903cd98209 | 2023-10-16 | Warnings | M017 |
| Capsadyn | CAPSAICIN | Chorda Pharma, Inc | 07731045-0d2b-76b7-e063-6294a90af921 | 2023-10-11 | Warnings | M017 |
| WHITE FLOWER STRAIN RELIEF | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 65282267-de63-453a-a686-f8752c71b9ef | 2023-10-02 | Warnings | M017 |
| WHITE FLOWER ANALGESIC BALM FLORAL SCENTED | CAMPHOR, MENTHOL AND METHYL SALICYLATE | HOE HIN PAK FAH YEOW MANUFACTORY LTD | 4e9cb5aa-b0aa-4a5c-b561-cc38437758d8 | 2023-10-02 | Warnings | M017 |
| NATUREANCE BODY BALM | CAMPHOR | EROS GLOBAL CORP | 05b84fd2-8d8f-9249-e063-6294a90ae29f | 2023-09-19 | Warnings | M017 |
| U ICE COLD | MENTHOL | UNIVERSAL DISTRIBUTION CENTER LLC | 752ef0cd-f12a-3b9e-e053-2991aa0abeb1 | 2023-09-01 | Warnings | M017 |
| Family Wellness Pain Relief with Lidocaine | PAIN RELIEF WITH LIDOCAINE | FAMILY DOLLAR (Family Wellness) | 3a18119f-6c75-4cea-a990-97cb8a9589d4 | 2023-08-29 | 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 |