Capsaicin 0.035 Percent
- Product NDC
- 50488-1035
- Requested package NDC
- 50488-1035-1
- 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 |
|---|---|---|---|---|---|---|
| HealthWise 3x Medicated Pain Relief Patch | CAMPHOR,MENTHOL, METHYL SALICYLATE | Veridian Healthcare | 164d4d62-00c0-e06d-e063-6294a90abd73 | 2024-04-17 | Warnings | M017 |
| TIGER Balm PAIN RELIEVING HYDROGEL | CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM | Haw Par Healthcare Ltd. | ca601b02-e9be-4d8d-a384-c62553302ceb | 2024-04-16 | Warnings | M017 |
| Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 1592a40a-a647-34bd-e063-6394a90a0a10 | 2024-04-08 | Warnings | M017 |
| Menticam | CAMPHOR, MENTHOL, METHYL SALICYLATE | PureTek Corporation | 081837a8-9669-be1f-e063-6394a90a9d20 | 2024-04-05 | Warnings | M017 |
| Pain Relieving Liniment | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 97a0c839-0927-4e54-aee2-ded2016ac4a0 | 2024-04-02 | Warnings | M017 |
| HealthWise Capsaicin Heat Patch | CAPSAICIN | Veridian Healthcare | 150c1f09-8aa7-67ea-e063-6294a90a950a | 2024-04-01 | Warnings | M017 |
| HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent | LIDOCAINE HCI | Veridian Healthcare | 150d3e54-5c8d-19ef-e063-6394a90a70c2 | 2024-04-01 | Warnings | M017 |
| Meijer Pain Relief Cream | LIDOCAINE | Meijer Distribution | 07ecee44-387a-cdce-e063-6294a90ab9c9 | 2024-03-27 | Warnings | M017 |
| Hydrocortisone Cream | HYDROCORTISONE | Trifecta Pharmaceuticals USA | 141aa2a7-8789-1127-e063-6294a90a2d23 | 2024-03-20 | Warnings | M017 |
| Pain Relief Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | 1dc21c95-b419-4175-85f8-040b73060d37 | 2024-03-20 | Warnings | M017 |
| Pain Relief Roll-On Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | d94ae654-ce25-4bff-b9bd-24a0e0e8568a | 2024-03-20 | Warnings | M017 |
| Pain Relief Muscle | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | f8bff018-fb4f-47b4-b8f8-4a496aede346 | 2024-03-20 | Warnings | M017 |
| Rugby Arthritis Pain Relieving Topical Analgesic | CAPSAICIN | Rugby Laboratories | 8f1bc075-97ac-4154-8768-0d878104c3ba | 2024-03-14 | Warnings | M017 |
| Rugby Ice Blue External Analgesic | MENTHOL, UNSPECIFIED FORM | Rugby Laboratories | 2b65cb6a-4364-4770-b7b9-5c4637edd01a | 2024-03-14 | Warnings | M017 |
| Leader Cooling Pain Relief Topical Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | fd06d17f-4dff-42a9-a84f-904809ceb981 | 2024-03-13 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | EROS GLOBAL | b3495c95-ba4b-9459-e053-2a95a90a710f | 2024-03-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | TRIFECTA PHARMACEUTICALS USA LLC | 1369e70f-7a61-7078-e063-6394a90a9a88 | 2024-03-11 | Warnings | M017 |
| Pain Reliever Cream | MENTHOL 10%, METHYL SALICYLATE 15% | Trifecta Pharmaceuticals USA, LLC. | 130665d6-3de8-cb91-e063-6294a90a2083 | 2024-03-06 | Warnings | M017 |
| Dermachange Aid Anti-Itch | DIPHENHYDRAMINE HCL | Private Label Beauty and Wellness | 12ed906c-d028-0ff7-e063-6394a90aaa52 | 2024-03-05 | Warnings | M017 |
| Dermachange Cold Therapy | MENTHOL | Private Label Beauty and Wellness | 12ef7dd8-3da3-9c87-e063-6394a90ac924 | 2024-03-05 | 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 |