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 |
|---|---|---|---|---|---|---|
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | 66b13044-69d2-4559-9e65-8a4c601c077a | 2025-10-06 | Warnings | M017 |
| Methyl Salicylate | METHYL SALICYLATE | PHARMACURE LLC | f119a1bd-095f-41f5-86d5-c0ee4f19fd2c | 2025-10-06 | Warnings | M017 |
| LIDOCAINE | LIDOCAINE | PHARMACURE LLC | 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32 | 2025-10-06 | Warnings | M017 |
| Tempo cool | MENTHOL | The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E | bd642389-6d03-4e09-a71c-312fb90eae89 | 2025-10-06 | Warnings | M017 |
| Menthopatch Hot | MENTHOL , CAPSICUM EXTRACT | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 3d289be3-c237-4065-a8ac-e8c2e51b76a5 | 2025-10-06 | Warnings | M017 |
| Mentho patch cool | MENTHOL | THE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID | 02251a4a-fc6f-42c9-a244-6f4835de5edd | 2025-10-06 | Warnings | M017 |
| Feminine Anti-Itch Creme | BENZOCAINE, RESORCINOL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | aa6cc963-dc60-5222-e053-2995a90acaf6 | 2025-10-06 | Warnings | M017 |
| TheraCare 2% Diphenhydramine Anti-Itch Cream | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Veridian Healthcare | 5999b677-63dd-49c6-b5b8-7b3c117ecc5c | 2025-10-06 | Warnings | M017 |
| HealthWise Pain Relief | MENTHOL | Veridian Healthcare | 06be5331-7a1e-4ab3-9f17-2d350bd4b890 | 2025-10-02 | Warnings | M017 |
| equate Burn Relief | LIDOCAINE HYDROCHLORIDE | Walmart Inc | a90cbd92-80a5-4463-8152-b83165121a6f | 2025-10-02 | Warnings | M017 |
| AsperFlex HOT | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | a6cb0656-8866-44ff-b40c-73655ff68721 | 2025-10-02 | Warnings | M017 |
| AsperFlex Original Maximum Strength | MENTHOL | Akron Pharma Inc. | d766c61e-c48b-4aff-97b0-678159479e03 | 2025-10-02 | Warnings | M017 |
| HealthWise Feminine Anti-Itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 1f9110da-f448-8e20-e063-6294a90a4275 | 2025-10-02 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | dc704403-e2aa-47f7-a7f4-f6afe1547ca8 | 2025-10-01 | Warnings | M017 |
| PROSTAT FIRST AID Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | e02558a9-fe2b-4f28-9fd3-7308f859d759 | 2025-10-01 | Warnings | M017 |
| FL Burn Ease, 0.9g | LIDOCAINE | ProStat First Aid LLC | 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 | 2025-10-01 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), WHITE PETROLATUM | Carma Laboratories, Inc. | c7a7626c-cf82-4301-af79-c5e85367e777 | 2025-10-01 | Warnings | M017 |
| Viaderma Calm Anti-Itch | HYDROCORTISONE | ViaDerma Distribution, Inc. | 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e | 2025-10-01 | Warnings | M017 |
| AsperFlex Advance | CAMPHOR, MENTHOL, METHYL SALICYLATE | Akron Pharma Inc. | d23d7f2b-4dcd-4c31-9d12-340f233018b4 | 2025-10-01 | Warnings | M017 |
| HEATING PAIN RELIEF | METHYL SALICYLATE, MENTHOL | SUNSET NOVELTIES, INC | 4024d604-c8c7-2d73-e063-6294a90a2e80 | 2025-10-01 | 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 |