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 |
|---|---|---|---|---|---|---|
| New Terocin | METHYL SALICYLATE, CAPSAICIN, AND MENTHOL | ASCLEMED USA INC. | 68dc0231-3364-448b-bde9-f19fa122c765 | 2026-05-05 | Warnings | M017 |
| Lidocaine 4% Patch | LIDOCAINE 4% | SOLA Pharmaceuticals | c31957dd-edea-ce98-e053-2a95a90a9c2d | 2026-05-05 | Warnings | M017 |
| Biofreeze Triple Target Gel | CAMPHOR, CAPSAICIN, MENTHOL | Reckitt Benckiser LLC | 511852c8-7428-3234-e063-6394a90a5bc2 | 2026-05-05 | Warnings | M017 |
| 5Kind DMSO Pain Relieving | CAMPHOR (SYNTHETIC) | 5Kind Trading LTD | 62b55114-47f4-473a-8406-78238c3c1fa2 | 2026-05-04 | Warnings | M017 |
| Zinc Oxide with Menthol and White Petrolatum | MENTHOL, ZINC OXIDE, WHITE PETROLATUM | Aldermed Inc. | f993fc0a-bd80-4345-a948-65ac03f910e2 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | EVERLIT GLOBAL INC. | d7ec5720-4d1f-4943-ae36-c7d6acbae7d7 | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE PRODUCTS BURN RELIEF | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 5371dae4-ea63-46cc-ac26-5418f359c63e | 2026-05-04 | Warnings | M017 |
| EVERLIT CARE BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | a2cf1726-3dc9-4624-b898-ac91fb4cbdb2 | 2026-05-04 | Warnings | M017 |
| FIRSTAR BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 186343c5-2e71-49c4-8d64-5fb3131239fa | 2026-05-04 | Warnings | M017 |
| Feminine Anti Itch Cream | BENZOCAINE,RESORCINOL | TRIFECTA PHARMACEUTICALS USA LLC | 50c3acbf-b873-908a-e063-6294a90a66b7 | 2026-05-01 | Warnings | M017 |
| 24 7 Relief and Recovery Pain Relieving | MENTHOL, UNSPECIFIED FORM | Triplicare Inc | 53ca807b-3ec2-4b5e-aa5a-6dcb756bb423 | 2026-04-30 | Warnings | M017 |
| FIRST AID BURN | LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE | 4 Visions LLC | 50b1351d-72dd-e0c9-e063-6294a90ac743 | 2026-04-30 | Warnings | M017 |
| TheraCare Flexible Pain Relieving | LIDOCAINE | Veridian Healthcare | 4f108002-2cae-0671-e063-6294a90ab6cf | 2026-04-30 | Warnings | M017 |
| Pain Relief Gel Roll On | MENTHOL | Trifecta Pharmaceuticals USA | 50b1a420-d5cd-6d61-e063-6294a90a0451 | 2026-04-30 | Warnings | M017 |
| Dr. Numb | LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM | Shinpharma Inc | d8cdccdb-775b-4970-a6ea-50b62df221d6 | 2026-04-30 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Padagis Israel Pharmaceuticals Ltd | 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 | 2026-04-29 | Warnings | M017 |
| anti itch | HYDROCORTISONE | HyVee Inc | e1db3641-2e83-4fec-8394-98d0d876ce0d | 2026-04-29 | Warnings | M017 |
| Eagle Brand Medicated Roll On | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 50805eee-33b3-86bd-e063-6294a90a77d8 | 2026-04-28 | Warnings | M017 |
| FixMySkin Healing Balm Vanilla Flavor | HYDROCORTISONE | Lovely Skin, Inc. | 52f7a561-a0b5-4562-a588-d74fd874b83a | 2026-04-28 | Warnings | M017 |
| Blue Star Medicated | CAMPHOR | Focus Consumer Healthcare, LLC | 56df008e-a23b-4870-e054-00144ff8d46c | 2026-04-27 | 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 |