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 |
|---|---|---|---|---|---|---|
| Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | MENTHOL,PRAMOXINE HYDROCHLORIDE | Rida LLC | b62d09e4-7ced-49a9-8c83-3a8ef580f25a | 2026-06-23 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | PRAMOXINE HYDROCHLORIDE | Rida LLC | 5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2 | 2026-06-23 | Warnings | M017 |
| Pain Relieving cleansing spary | BENZALKONIUM CHLORIDE AND LIDOCAINE HCI | Trifecta Pharmaceuticals USA, LLC. | 48edbb8d-0c35-91d8-e063-6394a90a71b8 | 2026-06-19 | Warnings | M017 |
| Pain Relief | MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 493ab515-5cda-7b5a-e063-6294a90a295b | 2026-06-19 | Warnings | M017 |
| Tiger Balm Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 011fc383-10bc-44cf-a67c-4be45fef33e0 | 2026-06-19 | Warnings | M017 |
| CVS Health Scalp Relief | SALICYLIC ACID | CVS Health | 8de46015-817c-4cd9-95f8-293424f2a5c4 | 2026-06-19 | Warnings | M017 |
| Careland Kinesiology Dual Action Pain Relieving Tape | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 67e0b3c5-e88e-4c48-a1e8-39f502ac249d | 2026-06-18 | Warnings | M017 |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | 549348ec-2eb2-3781-e063-6294a90a2f4a | 2026-06-18 | Warnings | M017 |
| SprayPain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | c603e999-2316-496a-e053-2995a90ab4ed | 2026-06-17 | Warnings | M017 |
| SprayPain Away Lavender | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | 547e2167-ade0-ac7e-e063-6294a90a18ea | 2026-06-17 | Warnings | M017 |
| Roll Pain Away | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547e647b-0205-221c-e063-6294a90a757c | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lemongrass | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef5c0-bc31-d83e-e063-6394a90abfa6 | 2026-06-17 | Warnings | M017 |
| Roll Pain Away Lavender | CAPSAICIN | PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA | 547ef2d9-f5c7-9de1-e063-6394a90a218b | 2026-06-17 | Warnings | M017 |
| Velloryn EXTRA STRENGTH NEUROPATHY | VELLORYN EXTRA STRENGTH NEUROPATHY | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 547f755f-c65c-37ef-e063-6394a90aa220 | 2026-06-17 | Warnings | M017 |
| Neoteric Diabetic Skin Care 4 oz. | DIMETHICONE | RNA PHARMA LLC | 536f4e79-201b-7100-e063-6394a90a4f82 | 2026-06-16 | Warnings | M017 |
| Medi First Extra Strength Itch Relief | DIPHENHYDRAMINE, ZINC ACETATE | Unifirst First Aid Corporation | 54614e5b-8c72-d308-e063-6294a90a405d | 2026-06-16 | Warnings | M017 |
| AXE BRAND MEDICATED | MENTHOL, CAMPHOR AND METHYL SALICYLATE | LEUNG KAI FOOK MEDICAL CO PTE LTD | e4901fa6-0a3e-4b1f-b3b0-0bac8e5ce0b0 | 2026-06-16 | Warnings | M017 |
| Blue Ice Analgesic | MENTHOL | Delon Laboratories (1990) Ltd | 184ed488-6e62-40c6-bb71-1d523280fd6b | 2026-06-16 | Warnings | M017 |
| Medi-First Hydrocortisone 1 % Anti-Itch Cream | HYDROCORTISONE | Unifirst First Aid Corporation | 49f04e5d-746d-cbe9-e063-6294a90a7e88 | 2026-06-16 | Warnings | M017 |
| Lidozall Pro | LIDOCAINE HYDROCHLORIDE | V2 Pharma LLC | ecc26ba7-4ff6-43e6-bfb9-91a9cbb509ff | 2026-06-16 | 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 |