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 |
|---|---|---|---|---|---|---|
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | Warnings | M017 |
| Tact Cool Jelly | DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL | Sato Pharmaceutical Co., Ltd. | f34872c9-91b9-49db-8e41-5b54a069284a | 2023-12-01 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 348fde05-2797-4410-a1b2-99e64187c4fe | 2023-12-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Proficient Rx LP | 85a7809e-c43f-4138-a85b-44e1b586def5 | 2023-12-01 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 66681906-c5f5-4c57-bb43-9c83cccc0062 | 2023-12-01 | Warnings | M017 |
| Lidozen Patch | LIDOCAINE, MENTHOL | Proficient Rx LP | c0df4b8b-2679-4652-9144-a8db916a186b | 2023-12-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 7c300dec-cefd-4b79-a948-a917b7708a04 | 2023-12-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 2adf3c4d-636f-4e02-b501-946b4df5f5d6 | 2023-12-01 | Warnings | M017 |
| Lidozen | LIDOCAINE, MENTHOL | Proficient Rx LP | 488d665c-a4fe-4a69-bab3-34b2347f4b05 | 2023-12-01 | Warnings | M017 |
| Thera Plus Max Strength Lidocaine Pain Relief Liquid | LIDOCAINE HYDROCHLORIDE | Fourstar Group USA, Inc. | 0a228b06-0e1c-6c75-e063-6294a90a9a0e | 2023-11-30 | Warnings | M017 |
| Thera Plus Cool and Heat Pain Relieving Gel Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2023-11-30 | Warnings | M017 |
| Bloop Itch Soothing Topical | HYDROCORTISONE | Three Nations Corp | 0b64677e-d4bf-0929-e063-6294a90af137 | 2023-11-30 | Warnings | M017 |
| Ice Quake | MENTHOL | Southern Sales & Service, Inc. | 7a05832f-49ac-4013-b240-4405501e45cd | 2023-11-29 | Warnings | M017 |
| ICE MUSCLE RUB Leon M.C | MENTHOL | Southern Sales & Service, Inc. | 4efaf347-7406-4690-8005-e7cf2e3d4222 | 2023-11-29 | Warnings | M017 |
| IceQuake Analgestic White | METHYL SALICYLATE, MENTHOL | Southern Sales & Service, Inc. | 54e5dcd5-9987-488d-a758-d0e76d155182 | 2023-11-29 | Warnings | M017 |
| Icequake Coldn Hot medicated patch | MENTHOL | Southern Sales & Service, Inc. | 89202c52-9eb7-4e5a-a709-4a66ab0d3a72 | 2023-11-29 | Warnings | M017 |
| IceQuake Lidocaine Analgesic | LIDOCAINE HYDROCHLORIDE | Southern Sales & Service, Inc. | 9089cb78-e9f8-4437-a767-df809a114c4b | 2023-11-29 | Warnings | M017 |
| Ice Quake Muscle Rub Blue | MENTHOL | Southern Sales & Service, Inc. | 5180f6a3-58f1-4c50-a33b-7d85a3c1b99b | 2023-11-29 | Warnings | M017 |
| Discount Drug Mart Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Discount Drug Mart | 8579df23-ac07-9df8-e053-2991aa0a8bbb | 2023-11-29 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf | 2023-11-28 | 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 |