AleveX
- Product NDC
- 0280-0063
- 11-digit product format
- 002800063
- Labeler code
- 0280
- Product ID
- 0280-0063_45262976-7ea4-6a50-e063-6394a90a1c06
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- camphor and menthol
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Bayer HealthCare LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-04-01
- Substance
- CAMPHOR (SYNTHETIC); MENTHOL
- Active strength
- 5.5; 16 mg/g; mg/g
- 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
- AleveX
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAMPHOR (SYNTHETIC) | 5.5 mg/g |
| MENTHOL | 16 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bafdf06b-25f5-e29e-e053-2a95a90a5e1b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0063-01 | AleveX | 77 g in 1 TUBE | LOTION | 77 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0063-01 | GM - Gram | 0280-0063 | 1a677620-824e-4cf5-ac3b-684fda94314c | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Ling Nam Hung Far | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | b6916b6e-b7eb-1eb7-e053-2995a90ae6fb | 2024-07-18 | Warnings | M017 |
| itch relief | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Bionpharma Inc. | 178ed513-4f22-8f11-e063-6294a90a109b | 2024-07-16 | Warnings | M017 |
| POWERECT Benzocaine Male Delay Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 2fafe1f2-a31e-4b2a-bc51-81e16b319c3a | 2024-07-16 | Warnings | M017 |
| SKINS DELAY Climax Control Benzocaine Gel | BENZOCAINE | SKINS SEXUAL HEALTH LIMITED | 53730576-2609-4f28-8bfa-a1ceea698b83 | 2024-07-16 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray. | PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a0346-3b00-4803-e063-6294a90aec6d | 2024-07-13 | Warnings | M017 |
| Tidl Pain Relief Evening Therapy Spray. | PAIN RELIEF EVENING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d1a2f4a-7b25-e595-e063-6394a90a00d5 | 2024-07-13 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY ROLL-ON | PAIN RELIEF HEAT THERAPY ROLL-ON | Shenzhen Sam Technology Co., Ltd. | 1d0b7b8f-9e5d-00f7-e063-6394a90af87c | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY original formula Spray. | PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0b94ec-f956-dff2-e063-6294a90aca4a | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray. | PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d0bf4f9-6b02-6cec-e063-6294a90a36c7 | 2024-07-12 | Warnings | M017 |
| Burn Relief | LIDOCAINE HCI 2.0% | Trifecta Pharmaceuticals USA, LLC. | e5e524cd-bb22-715f-e053-2995a90ab5d3 | 2024-07-12 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | 1d10e3ca-dc93-8e1a-e063-6394a90a47c0 | 2024-07-12 | Warnings | M017 |
| TIDL PAIN RELIEF HEAT THERAPY Spray. | PAIN RELIEF HEAT THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d199826-1b27-b6e7-e063-6394a90a69ad | 2024-07-12 | Warnings | M017 |
| Tidl Pain Relief Morning Therapy Spray. | PAIN RELIEF MORNING THERAPY SPRAY | Shenzhen Sam Technology Co., Ltd. | 1d19d070-3818-73de-e063-6394a90a8958 | 2024-07-12 | Warnings | M017 |
| Hydrocortisone with aloe | HYDROCORTISONE WITH ALOE ANTI ITCH | NeilMed Pharmaceuticals Inc. | 032b9f58-5f64-04dd-e063-6294a90a6bb9 | 2024-07-10 | Warnings | M017 |
| Octagon Pain Relief | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 9926f733-1506-4224-9d70-b1813cd81ec3 | 2024-07-08 | Warnings | M017 |
| LidoReal Patch | LIDOCAINE AND MENTHOL | FORREAL PHARMACEUTICALS LLC | 19f1c037-b4b8-47b0-b0f9-036691c1d307 | 2024-07-05 | Warnings | M017 |
| Lip Medex Lip Balm | PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL | Blistex Inc. | 988f97e8-a59f-4bc0-9d71-60607364a686 | 2024-07-01 | Warnings | M017 |
| Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM | MENTHOL | L'Oreal USA Products Inc | d580982f-dda6-4b03-bf84-342b9f2c6d93 | 2024-06-29 | Warnings | M017 |
| Lip Medex Cherry | PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM | Blistex Inc. | fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8 | 2024-06-28 | Warnings | M017 |
| 10% Methyl Salicylate Pain Relief Patch | 10% METHYL SALICYLATE | Akron Coating & Adhesives | 1be1f1ce-3238-a8ed-e063-6294a90a5aed | 2024-06-27 | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0063-01 | 00280006301 | 77 g in 1 TUBE (0280-0063-01) | 77 g | 2021-04-01 | 0000-00-00 | No | No | Current |