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 |
|---|---|---|---|---|---|---|
| Veneno de Abeja Aceite De Vibora Brand | METHYL SALICYLATE | Menper Distributors Inc. | ad940dc8-9403-44cf-aed3-6e538cbe488b | 2025-07-22 | Warnings | M017 |
| Balsamo de Vaca Mascura | METHYL SALICYLATE | Menper Distributors Inc. | 321b6f1f-c802-4b96-99d3-e77217da11a3 | 2025-07-22 | Warnings | M017 |
| Abejas y Viboras Roll On | METHYL SALICYLATE | Menper Distributors Inc. | bedf3b36-7def-099f-e053-2a95a90ac15b | 2025-07-22 | Warnings | M017 |
| HealthWise Flexible 4% Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3869cc18-5494-6142-e063-6394a90a75e5 | 2025-07-22 | Warnings | M017 |
| Arthcal 4% Lidocaine Patches | LIDOCAINE | Beijing JUNGE Technology Co., Ltd. | 2e531194-67ad-c645-e063-6394a90a916c | 2025-07-22 | Warnings | M017 |
| AMRUTANJAN RELIEF STRONG PAIN BALM | MENTHOL, METHYL SALICYLATE | AMRUTANJAN HEALTH CARE LIMITED | 206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27 | 2025-07-22 | Warnings | M017 |
| Cold Sore Fast-Acting Pain Relief | GLYCERIN AND LIDOCAINE | Blistex Inc. | c7511322-dd6c-441c-bf7d-ad4f0c14956a | 2025-07-22 | Warnings | M017 |
| Mountain Ice Sports Pain Relief | MENTHOL, CAMPHOR | Mountainside Medical Equipment, Inc. | c1f5512c-67b1-4ff0-b1a5-616e883d436f | 2025-07-21 | Warnings | M017 |
| Stopain Clinical Roll-On | MENTHOL, UNSPECIFIED FORM | Troy Manufacturing, Inc. | 27703209-fdac-4620-a445-d89a84bc853d | 2025-07-21 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | 9bac1869-8072-49bd-8568-a87a184d2200 | 2025-07-21 | Warnings | M017 |
| Dr Kevin Khalili Pain Relief Cream | MENTHOL | DR. KHALILI LLC | 3a79b38c-9adc-60dd-e063-6394a90a5b30 | 2025-07-21 | Warnings | M017 |
| ARTHRITIS PAIN RELIEF | CAMPHOR, CAPSAICIN, METHYL SALICYLATE | YUNNAN BAIYAO GROUP CO., LTD. | 671c57f0-3c6f-4416-bc81-f6930fef327b | 2025-07-21 | Warnings | M017 |
| GoodSense Cooling Pain Relief | MENTHOL | Geiss, Destin & Dunn, Inc | 2e5e1375-df07-9a43-e063-6394a90a9938 | 2025-07-20 | Warnings | M017 |
| Benadryl Extra Strength Itch Cooling | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | a7eae5dc-9db6-4bdf-9179-76060e75e044 | 2025-07-18 | Warnings | M017 |
| Nicotine Patches | NICOTINE PATCHES | Shenzhen TeLaFaErJiaLuo Technology Co., Ltd. | 3a1abd26-c0aa-8a65-e063-6294a90ab66e | 2025-07-17 | Warnings | M017 |
| Aouiv 4% Lidocaine Numbing Cream | 4% LIDOCAINE NUMBING CREAM | Guangzhou Qiexiran Cosmetics Co., Ltd. | 3a221dd2-e945-bd0e-e063-6294a90a8fb9 | 2025-07-17 | Warnings | M017 |
| Alocane Plus | LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE | Quest Products, Inc. | 24538037-1d74-48a0-b909-98ecc57651fe | 2025-07-17 | Warnings | M017 |
| Hydrocortisone anti-itch plus | HYDROCORTISONE | Wal-Mart Stores, Inc. | a0c6e180-b385-4a9b-a9cf-84a551f533d0 | 2025-07-16 | Warnings | M017 |
| OTC Rescue Lidocaine Pain Relief Patch | LIDOCAINE | Veridian Healthcare | 0e742fc6-5f76-d202-e063-6394a90acf31 | 2025-07-16 | Warnings | M017 |
| Itch Relief | HYDROCORTISONE | STRATEGIC SOURCING SERVICES LLC | ae4b7cd6-8b5d-4d25-86f9-72260638bb94 | 2025-07-16 | 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 |