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
- 2026-12-31
- 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
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| MAXIMUM STRENGTH Lidocaine Plus Menthol | LIDOCAINE, MENTHOL | ARMY AND AIR FORCE EXCHANGE SERVICE | 60f72061-d264-424e-b396-5a609076d352 | 2026-08-20 | Warnings | M017 |
| MENTHOL, CAMPHOR | MENTHOL, CAMPHOR | SUNSET PAIN RELIEF | 5980c527-6bcb-a846-e063-6294a90a0788 | 2026-08-20 | Warnings | M017 |
| Pain Relief Patches | CAMPHOR, MENTHOL, METHYL SALICYLATE | Amerisource Bergen | 5fb5e5ce-b268-4444-8b63-ea7ea6abf269 | 2026-08-20 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 58c2b35c-e1ed-7ea8-e063-6294a90a1494 | 2026-08-19 | Warnings | M017 |
| Dr. Scholls Blister Pain Relief Complete Kit | LIDOCAINE | Scholl's Wellness Company LLC | 585e740b-e4fa-d2aa-e063-6294a90a0982 | 2026-08-19 | Warnings | M017 |
| Eagle Brand Muscular Balm | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0822bcde-a8ad-be95-e063-6294a90ad208 | 2026-08-19 | Warnings | M017 |
| ANTI ITCH | HYDROCORTISONE | HyVee Inc | 1ab6bbb8-2b91-4c53-9168-b1e85ac296e9 | 2026-08-19 | Warnings | M017 |
| hydrocortisone 1 | HYDROCORTISONE | Kroger Company | f05edff2-2dc5-427c-b52c-518e0aaef4e0 | 2026-08-19 | Warnings | M017 |
| MedPride | HYDROCORTISONE | Shield Line LLC | 2f15d3b3-d1e6-4742-9eac-f956c0ffbba4 | 2026-08-18 | Warnings | M017 |
| Pain Relieving Cream Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Garcoa, Inc. | 2f736307-5cd4-4a76-9044-4aeecba096cc | 2026-08-18 | Warnings | M017 |
| Lidocaine Pain Relief Roll on | PAIN RELIEF ROLL ON | NeilMed Pharmaceuticals Inc | 58ff9d2d-99e6-8f98-e063-6394a90a8de7 | 2026-08-17 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1/2% | Sun Pharmaceutical Industries, Inc. | 59337940-c9be-58af-e063-6394a90abe13 | 2026-08-16 | Warnings | M017 |
| SIERQ Numbing | MENTHOL | Putian Licheng District Zhijiancheng Trading Co., Ltd. | 5936c070-d8e4-56e8-e063-6294a90a5600 | 2026-08-16 | Warnings | M017 |
| Jakwork Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5911d9b0-1acb-3546-e063-6294a90adb3a | 2026-08-15 | Warnings | M017 |
| Re-Lieved Lidocaine Patch | LIDOCAINE PATCH 4% | Transfer Technology | 59072f05-eefa-d823-e063-6394a90a0e1a | 2026-08-14 | Warnings | M017 |
| JJ Care First Aid Burn | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Nantong Health & Beyond Hygienic Products Inc. | c41621fb-c549-4394-a4cb-cb81ef8c98df | 2026-08-13 | Warnings | M017 |
| JJ Care | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | c88fa151-f8a8-4de2-98c9-71319bf53e36 | 2026-08-13 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Safetec of America, Inc. | da2b3b2c-11e0-401b-bbd2-d019271d1b3d | 2026-08-13 | Warnings | M017 |
| CVS Pain Relief Roll-On Lidocaine with Lavender | LIDOCAINE HYDROCHLORIDE | CVS Pharmacy | 4aa53176-2103-b47b-e063-6394a90ac735 | 2026-08-12 | Warnings | M017 |
| JUST CBD SOOTHING | MENTHOL, CAMPHOR | Just Brands LLC | 5384e80f-c242-76a1-e063-6294a90aba0b | 2026-08-12 | 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 |