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 |
|---|---|---|---|---|---|---|
| A Health Itch Relief Gel | ITCH RELIEF GEL | Pharma Nobis, LLC | 4f80c403-c760-31ec-e063-6394a90a61c9 | 2026-04-15 | Warnings | M017 |
| Family Care Antibiotic Pain Relief 0.33oz | ANTIBIOTIC PAIN RELIEF | United Exchange Corp | 4f8405fc-3e38-05d9-e063-6394a90a4cda | 2026-04-15 | Warnings | M017 |
| BiteMD | INSECT BITE RELIEF | Wisconsin Pharmacal Company | 4f860c1e-a638-4923-e063-6294a90ae7e2 | 2026-04-15 | Warnings | M017 |
| LavaDerm AfterSun | MENTHOL | Young Living Essential Oils, LC. | 4fcddcf1-36db-2f1a-e054-00144ff8d46c | 2026-04-15 | Warnings | M017 |
| Arlun Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f8b60f9-03e3-e731-e063-6294a90a3b0a | 2026-04-15 | Warnings | M017 |
| tuiwaro Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f66178c-95d9-8c6a-e063-6294a90a2c09 | 2026-04-14 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Pharma Nobis, LLC | 4f6d9a51-c42e-ca88-e063-6394a90a8659 | 2026-04-14 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Pharma Nobis, LLC | 4f6f5a0b-3bfa-289e-e063-6294a90a94b3 | 2026-04-14 | Warnings | M017 |
| Sting Relief Swab | BENZOCAINE | 4 Visions LLC | 4f76a8c5-fde6-eee0-e063-6394a90a09f8 | 2026-04-14 | Warnings | M017 |
| Signature Pain Relief Cream | 4% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 4f555b8f-5193-e685-e063-6294a90a7ba2 | 2026-04-13 | Warnings | M017 |
| Deep Numbing Cream | MENTHOL | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD | 7943559b-de10-4214-96dc-f9cbac828f46 | 2026-04-13 | Warnings | M017 |
| Hydrocortisone Cream 1% | HYDROCORTISONE CREAM 1% WITH ALOE | Publix Super Markets Inc. | 3c45a654-7fec-55b3-e063-6294a90a184b | 2026-04-13 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | AMERISOURCE BERGEN | 4f5aea1c-ae51-4e1a-e063-6294a90a6aa1 | 2026-04-13 | Warnings | M017 |
| ActivICE | MENTHOL | Medline Industries, LP | 8465b443-abe9-78fb-e053-2a91aa0ac1d8 | 2026-04-13 | Warnings | M017 |
| 4Jointz | MENTHOL | ARP(USA) Pty Ltd | 94a5b5f5-abf7-40b3-9dd7-43e2c22f138e | 2026-04-13 | Warnings | M017 |
| Sumifun Pain Relief Creams | METHYL SALICLATE CAPSAICIN CAMPHOR | Guchutang Biotechnology (Longyan) Co., Ltd | 4f3dd96a-d843-d810-e063-6394a90a188e | 2026-04-12 | Warnings | M017 |
| BonicaEaseX 24 Hour Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co., Ltd. | 17fc0cd1-710d-45e6-9513-d7100e3adb42 | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Colorless Roll-On Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | acf460b4-1b41-4b30-a74a-6c3613119d8e | 2026-04-10 | Warnings | M017 |
| BonicaEaseX Menthol Pain Relieving | MENTHOL, UNSPECIFIED FORM | Planet (Anhui) Pharmaceutical Co.,Ltd | 4d84b4fb-8f55-4b2b-b261-858edb7f3144 | 2026-04-10 | Warnings | M017 |
| HealthWise Pain Relief Gel Patch | CAPSAICIN, MENTHOL | Veridian Healthcare | f5484151-b6da-4f64-867f-87160a4ec2d6 | 2026-04-10 | 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 |