Capsaicin 0.035 Percent
- Product NDC
- 50488-1035
- 11-digit product format
- 504881035
- Labeler code
- 50488
- Product ID
- 50488-1035_e2a30b7f-bcde-4a77-bcbd-3e965d4f8004
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsaicin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alexso, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-01
- Substance
- CAPSAICIN
- Active strength
- .035 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Percent
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAPSAICIN | .035 g/100g |
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 |
|---|---|
| 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 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 |
|---|---|---|---|---|---|---|
| 50488-1035-1 | Capsaicin 0.035 Percent | 120 g in 1 BOTTLE | CREAM | 120 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-1035-1 | GM - Gram | 50488-1035 | 41964388-d8a5-429d-8c3a-dccbbb9de672 | 1 | 2026-04-20 |
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 |
|---|---|---|---|---|---|---|
| Sunburn Relief Gel | LIDOCAINE HCL | Amazon.com Services LLC | adb638ec-4a7c-42f2-b249-0ac53a8dd4b2 | 2026-03-03 | Warnings, Adverse reactions | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Amazon.com Services LLC | 2acb1a6a-57e6-4915-b03a-89d1d2db3baf | 2026-03-03 | Warnings, Adverse reactions | M017 |
| Diphenhydramine Hydrochloride and Zinc Acetate | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | STRATEGIC SOURCING SERVICES LLC | ec0c9602-35cc-4bb6-b853-794a8b5bf42e | 2026-03-03 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE 1% | PHARMACY CHOICE INC | 4cdfe8b6-c332-7bf8-e063-6394a90abaec | 2026-03-03 | Warnings | M017 |
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 4c06c4a4-557b-8bb1-e063-6294a90a9125 | 2026-03-02 | Warnings | M017 |
| Sunburn Relief | LIDOCAINE HCL 0.5% | Old East Main Co. | 49173ec8-c94a-44c9-8a13-0f4b01b96cd6 | 2026-03-02 | Warnings, Adverse reactions | M017 |
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Old East Main Co. | 6d87547f-bf4c-4dda-bd9d-32b576afd805 | 2026-03-02 | Warnings, Adverse reactions | M017 |
| Still Standing | MENTHOL, UNSPECIFIED FORM | Natural Essentials Inc. | 66974aaf-c82f-4fe9-bfb3-3430b80ac9f2 | 2026-03-02 | Warnings | M017 |
| Lightning Pain Relief | MENTHOL | Clinical Resolution Laboratory, Inc. | 80af21f5-dba8-42b0-8a65-ac5a94d83ca8 | 2026-03-02 | Warnings | M017 |
| Icy Hot Lidocaine No-Mess | LIDOCAINE HYDROCHLORIDE | Chattem, Inc. | 347f9a18-8ab6-47d3-9610-5b4e9ca5d53a | 2026-03-02 | Warnings | M017 |
| Gold Bond Maximum Strength Foot Pain Relief | LIDOCAINE HYDROCHLORIDE | Gold Bond Co LLC | 8e469076-2f5a-4de8-8d13-a38c072b9af8 | 2026-03-01 | Warnings | M017 |
| HealthWise Pain Relief Lidocaine | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 48ecbab9-13e0-d0fa-e063-6294a90a6ff2 | 2026-02-28 | Warnings | M017 |
| NUMBING CREAMS | LIDOCAINE | Yongchun Lihui Trading Co., Ltd. | 3b5e1a74-5946-4f1f-e063-6394a90a404b | 2026-02-27 | Warnings | M017 |
| Pain Relieving Gel | LIDOCAINE HYDROCHLORIDE | Chain Drug Marketing Association | b55b7253-2fd2-45cc-b94c-e92395ab0d2b | 2026-02-27 | Warnings, Adverse reactions | M017 |
| MEDISTIK PROFESSIONAL DUAL ACTION | MENTHOL, METHYL SALICYLATE, EUCALUPTUS | Natureteq Inc. | 99c7f08a-ab14-4371-9147-189f75cb6633 | 2026-02-27 | Warnings | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Walmart Inc. | 309dcf5b-7166-976a-e063-6394a90af952 | 2026-02-27 | Warnings, Adverse reactions | M017 |
| ASYSTEM Radical Relief Gel Roll-On | MENTHOL, METHYL SALICYLATE | Cosco International, Inc. | 7239733e-5510-4a63-96c3-dd88b4a431a3 | 2026-02-27 | Warnings | M017 |
| Icy Hot Pro Pain Massaging Balm | CAMPHOR AND MENTHOL | Chattem, Inc. | 09e2b0cb-5186-4f9c-b256-edaced4ca014 | 2026-02-27 | Warnings | M017 |
| Lidocaine Pain Relief | LIDOCAINE PAIN RELIEF | PAI Holdings, LLC dba PAI Pharma | 963978de-8295-47ee-9b06-64c3521aa994 | 2026-02-26 | Warnings | M017 |
| Tommie Copper Cooling Roller Lavender Scent | MENTHOL 4% | Tommie Copper, Inc. | 4bbfd4d1-9036-bc20-e063-6394a90a3feb | 2026-02-26 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 577395 | capsaicin 0.035 % Topical Cream | PSN | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
| 577395 | capsaicin 0.35 MG/ML Topical Cream | SCD | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
| 577395 | capsaicin 0.035 % Topical Cream | SY | 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50488-1035-1 | 50488103501 | 120 g in 1 BOTTLE (50488-1035-1) | 120 g | 2025-09-01 | No | No | Current |