Hot/Cold Menthol 16% Roll-On
- Product NDC
- 0395-9131
- 11-digit product format
- 003959131
- Labeler code
- 0395
- Product ID
- 0395-9131_0c93883b-eed9-0f96-e063-6394a90ae9aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Hot/Cold Menthol 16% Roll-On
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Humco Holding Group, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-12-21
- Substance
- MENTHOL
- Active strength
- 16 mg/100mL
- 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
- Hot/Cold Menthol 16% Roll-On
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 16 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a8bf9744-9979-13c1-e053-2a95a90a30aa | 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 |
|---|---|---|---|---|---|---|
| 0395-9131-97 | Hot/Cold Menthol 16% Roll-On | 74 mL in 1 CONTAINER | LIQUID | 74 | 3 |
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 |
|---|---|---|---|---|---|---|
| Soothing Lavender Foot Soak and Body Soak | CAMPHOR | SANSAR, LLC | ef26523a-b2f2-466e-89ad-f293cd64decb | 2025-03-27 | Warnings | M017 |
| Achelon Lidocaine Patch | LIDOCAINE PATCH 4% | Achelon, Inc | 31408e21-e58d-6db5-e063-6294a90aa4bc | 2025-03-26 | Warnings | M017 |
| Achelon Lidocaine Patch | LIDOCAINE PATCH 4% | Achelon, Inc | 3143bb72-2969-d66e-e063-6294a90a4604 | 2025-03-26 | Warnings | M017 |
| Parche Leon | CAPSAICIN, CAMPHOR, MENTHOL | Pharmadel LLC | a8f266fa-6e43-559e-e053-2995a90a2c75 | 2025-03-26 | Warnings | M017 |
| Adellina Numbing Cream | LIDOCAINE | Guangzhou Haishi Biological Technology Co., Ltd. | 314a83fe-8bdb-766f-e063-6294a90a61c6 | 2025-03-26 | Warnings | M017 |
| HealthWise Lidocaine Plus Menthol Patch | LIDOCAINE AND MENTHOL | Veridian Healthcare | 312f15fe-9297-2dc2-e063-6294a90a6f4d | 2025-03-25 | Warnings | M017 |
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 3130729d-1679-90cd-e063-6294a90a21e6 | 2025-03-25 | Warnings | M017 |
| HealthWise Lidocaine Patch | LIDOCAINE 4% | Veridian Healthcare | 31314dda-6199-574d-e063-6394a90aae7a | 2025-03-25 | Warnings | M017 |
| RWSEFK Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 31366793-f8a6-a2c4-e063-6294a90acbfc | 2025-03-25 | Warnings | M017 |
| Forticept Wounds and Burns Hydrogel | BENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | Lidan, inc. | c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f | 2025-03-25 | Warnings | M017 |
| MQ Pain Relieving Patch | PAIN RELIEVING PATCH | Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd | 0978ff22-c357-e266-e063-6394a90a98a4 | 2025-03-24 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Advanced Rx of Tennessee, LLC | 30c97646-db06-df84-e063-6394a90a7743 | 2025-03-20 | Warnings | M017 |
| Carmex Classic Lip Balm Medicated | CAMPHOR (SYNTHETIC), PETROLATUM | Carma Laboratories, Inc. | fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57 | 2025-03-20 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPF | CAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Carma Laboratories, Inc. | 5f904369-5f21-4907-98de-df23bce30823 | 2025-03-20 | Warnings | M017 |
| DermaCort Anti-itch | HYDROCORTISONE | Melaleuca, Inc. | 24044b0f-dd1e-4762-82b8-7a28b08c2f77 | 2025-03-20 | Warnings | M017 |
| AUVON Lidocaine Menthol Pain Relief Patch | LIDOCAINE AND MENTHOL | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 300cf469-5ca2-a40d-e063-6294a90a6801 | 2025-03-20 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 3a3af6e1-0281-462e-85e7-144cc5d46f32 | 2025-03-19 | Warnings | M017 |
| Lidocaine 4% | LIDOCAINE | Innovida Pharmaeutique Corporation | eb83a3dd-557e-4334-b806-5fc05e9175a3 | 2025-03-19 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | c04059e9-8175-46c2-8582-f84ef193abd3 | 2025-03-19 | Warnings | M017 |
| Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 | CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE | Carma Laboratories, Inc. | 3a36a241-37a9-445a-a6e0-97709a7457a8 | 2025-03-19 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0395-9131-97 | 00395913197 | 74 mL in 1 CONTAINER (0395-9131-97) | 74 ml | 2018-12-21 | 0000-00-00 | No | No | Current |