Capsaicin 0.035% Cream
- Product NDC
- 59088-246
- 11-digit product format
- 590880246
- Labeler code
- 59088
- Product ID
- 59088-246_3cbc73b6-8c59-8f23-e063-6394a90a71a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin 0.035% Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Puretekcorp
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-08-20
- Substance
- CAPSAICIN
- Active strength
- .35 mg/g
- 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 0.035% Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .35 mg/g |
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 |
|---|---|
| 3cbc73b6-8c58-8f23-e063-6394a90a71a3 | 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 |
|---|---|---|---|---|---|---|
| 59088-246-08 | Capsaicin 0.035% Cream | 120 g in 1 TUBE | CREAM | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59088-246-08 | GM - Gram | 59088-246 | 9babf7a1-115f-4b46-8a1d-8c33a1b6f74c | 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 |
|---|---|---|---|---|---|---|
| PAIN RELIEF PATCHES | LIDOCAINE | Amerisource Bergen | 614f1e56-891f-4620-be10-0c075a1dbc3f | 2025-09-11 | Warnings | M017 |
| Industrial Itch and Pain Relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | R & R Lotion, Inc | 236415fc-f923-4a82-b54a-ecaf666dd2e0 | 2025-09-11 | Warnings | M017 |
| Eco Lips Menthol Medicated Lip Balm | MENTHOL | Eco Lips, Inc. | fc4c25d6-6109-dfd8-e053-6394a90a4e91 | 2025-09-10 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Encube Ethicals, Inc. | d6f5c0df-6262-4704-bb24-430f66bb2ca8 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Lidocaine Pain Relief Cream | LIDOCAINE CREAM 4% | Kingsway Pharmaceuticals dba NFI, LLC | 592811f2-e21c-6a58-e053-2991aa0a69a9 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 | 2025-09-09 | Warnings | M017 |
| LubeLife Climax Control Delay | BENZOCAINE | CC Wellness LLC | e1a98e6d-0c24-75b8-e053-2a95a90ad136 | 2025-09-09 | Warnings | M017 |
| Blue-Emu Maximum Pain Relief | TROLAMINE SALICYLATE | Kingsway Pharmaceuticals dba NFI, LLC | c863351a-951b-4f7c-a9c0-4289d702054a | 2025-09-09 | Warnings | M017 |
| Tiger Balm Neck and Shoulder Rub | CAMPHOR (SYNTHETIC) AND MENTHOL | Haw Par Healthcare Ltd. | 02a65b25-78b2-4e29-9484-40e2228fb384 | 2025-09-09 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | e90df2e5-2ef4-47dd-bd74-be9cea6d9d85 | 2025-09-08 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Unifirst First Aid Corporation | 69d6645e-db3c-4dc0-a9a5-e2bc963e2f28 | 2025-09-08 | Warnings | M017 |
| SupreH Arnica Bruise Cream | SUPREH ARNICA REMEDY PLUS BRUISE CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3e41fc0e-54c3-2622-e063-6294a90a13c9 | 2025-09-07 | Warnings | M017 |
| Menthol | MENTHOL | FlexiGo Inc | 3607c326-6db0-a2cd-e063-6394a90a9eb6 | 2025-09-06 | Warnings | M017 |
| TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream | PAIN RELIEF CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e08cc87-2385-0838-e063-6394a90abf9b | 2025-09-05 | Warnings | M017 |
| TIDL CLINICAL CRYOTHERAPY MENTHOL Cream | CLINICAL CRYOTHERAPY MENTHOL CREAM | Shenzhen Sam Technology Co., Ltd. | 3e090b98-1db7-4174-e063-6394a90aa539 | 2025-09-05 | Warnings | M017 |
| ALCEMISTE | LIDOCAINE HCL | Price Team Ventures, LLC | 4383faaa-49cf-47b7-83a6-c2a94b6ff9b5 | 2025-09-05 | Warnings | M017 |
| Lansinoh Pain Relieving | LIDOCAINE HCL | Lansinoh Laboratories Inc | b7cf1fdb-946d-a4e8-e053-2995a90a26a8 | 2025-09-05 | Warnings | M017 |
| Sumifun PLANTAR RELIEF ROLL -ON | 4% LIDOCAINE, 1% MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 3c9ee60b-548a-979f-e063-6394a90a70b0 | 2025-09-03 | Warnings | M017 |
| Meijer Capsaicin Heat Patch | CAPSAICIN | Meijer Distribution | 3c465557-0a4f-fb72-e063-6294a90a1ef2 | 2025-09-02 | Warnings | M017 |
| Cold Therapy | MENTHOL | AHC Ventures Corp DBA Cryoderm | dd95c682-8ddf-43e7-a277-2fca6ec744cc | 2025-09-02 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577395 | capsaicin 0.035 % Topical Cream | PSN | 3cbc73b6-8c58-8f23-e063-6394a90a71a3 | 1 |
| 577395 | capsaicin 0.35 MG/ML Topical Cream | SCD | 3cbc73b6-8c58-8f23-e063-6394a90a71a3 | 1 |
| 577395 | capsaicin 0.035 % Topical Cream | SY | 3cbc73b6-8c58-8f23-e063-6394a90a71a3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59088-246-08 | 59088024608 | 120 g in 1 TUBE (59088-246-08) | 120 g | 2025-08-20 | No | No | Current |