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 Relieving Cooling | MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 3574d48a-b546-4ea7-b470-071bb328de64 | 2024-02-08 | Warnings | M017 |
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | M017 |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 8eb3e7e2-26e5-430e-89aa-40a0367c637e | 2024-02-07 | Warnings | M017 |
| Nova Natura Topical Analgesic | CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE | SEYITLER KIMYA SANAYI ANONIM SIRKETI | abf00f73-f0b1-439e-85aa-bbce8a1ec920 | 2024-02-06 | Warnings | M017 |
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | M017 |
| Pain Relieving Petro Carbo | PHENOL | J.R. Watkins, LLC. | 050cf17d-3be7-45b9-8524-ad82af309a0e | 2024-02-06 | Warnings | M017 |
| White Cream | CAMPHOR (NATURAL) AND TURPENTINE OIL | J.R. Watkins, LLC. | e4de0734-59d5-478c-86ea-66fc2ba003e7 | 2024-02-05 | Warnings | M017 |
| Pain Relieving Roll-On | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | 80118260-9c88-402d-9a90-ecfe62b4b54f | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL, UNSPECIFIED FORM | Safetec of America, Inc. | df512ce6-ce1b-434d-9571-fb2e1d76e1d0 | 2024-02-05 | Warnings | M017 |
| Pain Relieving | MENTHOL | Safetec of America, Inc. | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2024-02-05 | Warnings | M017 |
| Itch Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Safetec of America, Inc. | 4f4c801b-d894-4fa3-b024-6ca41a5f2a95 | 2024-02-04 | Warnings | M017 |
| Analgesic | MENTHOL | Safetec of America, Inc. | 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | 2024-02-04 | Warnings | M017 |
| HAV EZ Penetrating Pain Relief | MENTHOL | PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC | 70006efc-9cc8-4490-b28c-fcb23b1737c4 | 2024-02-01 | Warnings | M017 |
| Rugby Capsaicin External Analgesic | CAPSAICIN | Proficient Rx LP | 7c733a30-5002-49e7-a6bd-7737a1d2461e | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | ccb62898-b614-45b9-95ea-23e5e31893a8 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE | Proficient Rx LP | 0b26d92f-9d0e-46d4-a8bc-75d6da5f6199 | 2024-02-01 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Proficient Rx LP | c57d5f8e-5934-4cbb-999a-cdd55e5b105f | 2024-02-01 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Proficient Rx LP | 47e9fe84-bd0c-40ea-85de-e950bcacc557 | 2024-02-01 | 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 |