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 |
|---|---|---|---|---|---|---|
| HYDROCORTISONE | HYDROCORTISONE | Encube Ethicals, Inc. | 969cd576-82d3-4662-bbc1-3587a1f6a564 | 2025-11-10 | Warnings | M017 |
| Jelcaine Sterile | LIDOCAINE HCL JELLY USP, 2% | Brookfield Pharmaceuticals, LLC | 1a39d1de-7aa2-3068-e063-6394a90aed85 | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | c6e86a0f-6f9b-45b7-86ce-0bb1c198061a | 2025-11-10 | Warnings | M017 |
| Hush Anesthetic | LIDOCAINE | HUSH Anesthetic | 97ae1993-7268-4b7f-92e2-6004337d5650 | 2025-11-10 | Warnings | M017 |
| MENTHOL AND METHYL SALICYLATE | ELECTRIC MEDICATED BALM ULTRA STRENGTH | FEI FAH MEDICAL MANUFACTURING PTE LTD | 91e6d3b9-25bb-4015-9d96-bd27f93e5ada | 2025-11-10 | Warnings | M017 |
| E MEI SHAN MEDICATED | CAMPHOR, MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | bda1e7c1-42df-4126-a512-80f843b07fd0 | 2025-11-10 | Warnings | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEVING | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | 9850754b-ac94-4ec6-b75a-8096e5ac9456 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| TONG FENG DING PAIN RELIEF | CAMPHOR AND MENTHOL | Zhejiang Dingtai Pharmaceutical Co., Ltd | fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 5ef90782-8201-47d1-b57f-f032d4c9b06a | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Pain Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 1388ab3a-c26f-427d-898d-0d88411a5fba | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Solstice Capsaicin Patch Hot | CAPSAICIN | MADISON ONE ACME INC | f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf | 2025-11-10 | Warnings, Adverse reactions | M017 |
| Lung Choy Shung Pain Relief Liquid | MENTHOL AND CAMPHOR | MADISON ONE ACME INC | 4842c6ec-7823-4f6b-afc4-258fce2c2391 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| 701 DIEDA ZHENGTONG YAOGAO MEDICATED | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 115041ff-5046-4ca4-b54b-5652037e74bd | 2025-11-10 | Warnings, Adverse reactions | M017 |
| EXTRA STRENGTH HUA TUO PAIN RELIEF | CAMPHOR AND MENTHOL | MADISON ONE ACME INC | 0f269a41-4b56-4e22-b9cb-17d99bf76a57 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| ZANG HONG HUA PAIN RELIEVING | CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE | MADISON ONE ACME INC | e0a8811c-07cf-4dee-a0e5-13b8af1b27b6 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| NECK AND LUMBAR PAIN RELIEVING BALM | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | d06f0650-a5f6-4bc1-a70b-b0fc16968fa9 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| SHU JIN HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | ccb6740d-3399-4a2b-ae65-15ca557ba83b | 2025-11-10 | Warnings, Adverse reactions | M017 |
| GuruNanda Pain Relief | LIDOCAINE HYDROCHLORIDE | GuruNanda, LLC. | 3ab6a133-8dca-e14e-e063-6394a90a85e7 | 2025-11-10 | Warnings | M017 |
| HUO LUO PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 65581716-5a2c-4ee8-816d-00caed7b95b4 | 2025-11-10 | Warnings, Adverse reactions | M017 |
| JOSEPHS LION PAIN RELIEVING | CAMPHOR, MENTHOL, METHYL SALICYLATE | MADISON ONE ACME INC | 69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e | 2025-11-10 | Warnings, Adverse reactions | 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 |