Pain Relieving
- Product NDC
- 61010-4403
- 11-digit product format
- 610104403
- Labeler code
- 61010
- Product ID
- 61010-4403_10aa8eb6-5d50-bea9-e063-6394a90a3623
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-01
- Substance
- MENTHOL
- Active strength
- 4 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
- Pain Relieving
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 4 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 415974 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52ebf64d-095f-467e-bf51-dd8d33b58c7d | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61010-4403-1 | 2024-02-13 | C162847 | 48780-1 | 1030e365-2c4c-111a-e063-dadaa90a10e2 | 61010-4403-1 |
| 61010-4403-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2c4c-111a-e063-dadaa90a10e2 | 61010-4403-1 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-4403-1 | Pain Relieving | 113.4 g in 1 TUBE | GEL | 113.4 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-4403 | PAIN RELIEVING (MENTHOL) GEL [SAFETEC OF AMERICA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240214_52ebf64d-095f-467e-bf51-dd8d33b58c7d.zip |
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 |
|---|---|---|---|---|---|---|
| AVON footworks Maximum Strength Cracked Heel | BENZALKONIUM CHLORIDE, LIDOCAINE | The Avon Company | 1f45752e-4a55-431e-e063-6294a90aa57a | 2024-08-01 | Warnings | M017 |
| Relief | MENTHOL | La Mend, Inc. | 1f92de3a-7180-5884-e063-6294a90aebf5 | 2024-08-01 | Warnings | M017 |
| Meijer Medicated Foot Powder | MENTHOL | Meijer Distribution | 07ec6c20-73c4-e5e4-e063-6294a90a7e55 | 2024-07-29 | Warnings | M017 |
| Ralli Rapid Pain Relief | MENTHOL | Troy Manufacturing, Inc. | e05ec3b7-e9ab-4eaa-8518-86304336697c | 2024-07-29 | Warnings | M017 |
| Walgreens Roll-On | CAPSAISIN 0.1% | Walgreens Co | 1e65bf31-15c7-5e6a-e063-6394a90ac956 | 2024-07-29 | Warnings | M017 |
| Camphotrex | CAMPHOR, MENTHOL | PureTek Corporation | 3b6c6eef-e92d-497d-afe8-82356637c2b8 | 2024-07-26 | Warnings | M017 |
| Camphotrol | CAMPHOR, MENTHOL | PureTek Corporation | ccac9f37-a374-4765-e053-2a95a90ad2f7 | 2024-07-26 | Warnings | M017 |
| Real Time Pain Relief Foot | MENTHOL | Real Time Products Inc. | 29c8e06d-9b29-44f9-ac21-9160d06475cb | 2024-07-24 | Warnings | M017 |
| Capsaicin 0.075 Percent | CAPSAICIN | Alexso, Inc | 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd | 2024-07-22 | Warnings | M017 |
| TIDL Pain Relief CRYO Therapy Limited Edition | PAIN RELIEF CRYO THERAPY LIMITED EDITION | Shenzhen Sam Technology Co., Ltd. | 1d966b67-fd9c-eab6-e063-6294a90aa75e | 2024-07-19 | Warnings | M017 |
| Fruit of the Earth Aloe Vera Cool Blue | LIDOCAINE HYDROCHLORIDE | Fruit of the Earth, Inc. | 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 | 2024-07-19 | Warnings | M017 |
| Ultra Balm | MENTHOL AND METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | de997baf-aa04-474e-b912-3fc67e720d0b | 2024-07-19 | Warnings | M017 |
| Ling Nam Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | 3f16cce3-366f-41f3-8829-6de4082a8c19 | 2024-07-19 | Warnings | M017 |
| Koong Yick Hak Kwai Oil | TURPENTINE OIL | Ling Nam Medicine Factory (H.K.) Ltd. | bc33e185-3b42-98b5-e053-2995a90a6308 | 2024-07-18 | Warnings | M017 |
| Koong Yick Hung Fa | METHYL SALICYLATE | Ling Nam Medicine Factory (H.K.) Ltd. | 9c8a121d-6da2-4435-a2d7-a0b71d10740d | 2024-07-18 | Warnings | M017 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2 |
| 415974 | menthol 4 % Topical Gel | SY | 52ebf64d-095f-467e-bf51-dd8d33b58c7d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61010-4403-1 | 61010440301 | 113.4 g in 1 TUBE (61010-4403-1) | 113.4 g | 2019-11-01 | 0000-00-00 | No | No | Current |