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 |
|---|---|---|---|---|---|---|
| 5 Elementum Delay Wipes | BENZOCAINE DELAY WIPES | MSVenturesGroup O | 440539b0-612b-3b41-e063-6294a90a1ddd | 2026-02-05 | Warnings | M017 |
| COOLING PAIN RELIEF | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a156400-7001-d00d-e063-6294a90aa714 | 2026-02-05 | Warnings | M017 |
| burnrelief | LIDOCAINE HCL | Publix Super Markets, Inc. | 9660f5e1-d39e-4f86-bf96-dff0f3bb729d | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Aloe Vera Gel | LIDOCAINE HCL, MENTHOL | Publix Super Markets, Inc. | fe442f1e-7045-481a-a501-d629bf568dfb | 2026-02-05 | Warnings, Adverse reactions | M017 |
| Care Lix Pain Relief | SALICYLIC ACID | ACQUIRED B SCALE LLC | 65dffffd-ede1-45e2-aa91-bdd5df2df6a6 | 2026-02-05 | Warnings | M017 |
| 2.5% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 8075ba60-772c-4d1a-8584-722bb3e539be | 2026-02-05 | Warnings | M017 |
| 4% Menthol PAIN RELIEF | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 51ce716e-b9f3-4e64-8c8e-17520d40f192 | 2026-02-05 | Warnings | M017 |
| 2.0% LIDOCAINE BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | 2b58058a-f350-4029-b039-117caf1c0373 | 2026-02-05 | Warnings | M017 |
| 4% MENTHOL COLD THERAPY | MENTHOL | Nantong Health & Beyond Hygienic Products Inc. | 7acc7282-ef4f-41ec-b51d-a88dfed79bd7 | 2026-02-05 | Warnings | M017 |
| Cooling Gel | PAIN RELIEF COOLING GEL | NeilMed Pharmaceuticals Inc. | 49fb637b-ecc5-1f9b-e063-6294a90ab41a | 2026-02-04 | Warnings | M017 |
| Medicaine Sting and Bite | BENZOCAINE | Dynarex Corporation | b721607e-e36b-4691-a824-c8f520bd6386 | 2026-02-04 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | CHEMCO CORPORATION | 4a05f02e-e882-2cb2-e063-6394a90ad328 | 2026-02-04 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | CHEMCO CORPORATION | 4a065965-43bd-e0e3-e063-6294a90ad76a | 2026-02-04 | Warnings | M017 |
| Menthol plus Camphor Pain Relief | MENTHOL, CAMPHOR | Veridian Healthcare | 4a0969d3-1f06-3ba7-e063-6294a90a8627 | 2026-02-04 | Warnings | M017 |
| Relief Flex | MENTHOL | Beone Co., Ltd. | 49e6f0ef-78fb-26fe-e063-6294a90a6655 | 2026-02-03 | Warnings | M017 |
| NATURULZ ULTIMATE HEALING | CAPSAICIN | I SHAY COSMETICS INC | 436eac74-d07f-d718-e063-6394a90a8660 | 2026-02-03 | Warnings | M017 |
| TheraCare Muscle and Join Pain Relieving Cream | MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 18f9829e-c5f9-4253-e063-6394a90a70c6 | 2026-02-03 | Warnings | M017 |
| HYDROCORTISONE | HYDROCORTISONE | CVS PHARMACY, INC | 8b8cdb26-8e8f-4e95-9d83-d685c90afe01 | 2026-02-02 | Warnings | M017 |
| Muscular Balm | CAPSAICIN MENTHOL METHYL SALICYLATE | Eagle Indo Pharma, PT | 888f88fc-dcaf-93e5-e053-2a95a90a20e1 | 2026-02-02 | Warnings | M017 |
| Wang Prom Green Balm by Wang Prom | WANG PROM WANG PROM GREEN BALM BY VENTURE GO LLC | AMBIENCE FAMILY INC | 4a063898-16a4-695a-e063-6394a90adb93 | 2026-02-02 | 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 |