Analgesic
- Product NDC
- 61010-8201
- 11-digit product format
- 610108201
- Labeler code
- 61010
- Product ID
- 61010-8201_10981167-c8a2-e068-e063-6394a90ab165
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- menthol
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-09-01
- Substance
- MENTHOL
- Active strength
- 70 mg/L
- 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
- Analgesic
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 70 mg/L |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 79e3b0e7-4ba5-4b9d-a980-5b6f18dba802 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-8201-0 | Analgesic | 0.059 L in 1 BOTTLE, SPRAY | SPRAY | 0.059 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-8201 | ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240214_79e3b0e7-4ba5-4b9d-a980-5b6f18dba802.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 |
|---|---|---|---|---|---|---|
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | b505769e-9c46-3cf3-e053-2a95a90a4df9 | 2023-11-17 | Warnings | M017 |
| Hydrocortisone | ANTIPRURITIC (ANTI-ITCH) | BluePoint Laboratories | d6523993-d781-cdbc-e053-2a95a90af191 | 2023-11-17 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 4d91baf3-9655-4786-93b8-aa0d93fe0bf9 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMP | MENTHOL | KOBAYASHI Healthcare International, Inc. | 7ef03298-6623-4cf4-b21f-74b2ffc11c6e | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | 436e8578-b609-4b45-8f84-0d111140fda6 | 2023-11-16 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL | KOBAYASHI Healthcare International, Inc. | 08dcfa78-7332-4f19-90d7-fdd7d446848a | 2023-11-16 | Warnings | M017 |
| Totally Fun After Sun | LIDOCAINE HCL | MJ Products Association, LLC | 965a2a29-914c-4ad0-b25f-5df3c30da393 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f | 2023-11-15 | Warnings | M017 |
| ZIMS MAX FREEZE PRO FORMULA | MENTHOL, UNSPECIFIED FORM | KOBAYASHI Healthcare International, Inc. | b44beac3-1d20-434f-9a79-4fab1ac68791 | 2023-11-15 | Warnings | M017 |
| Universal Ice Cold Analgesic | MENTHOL | Universal Distribution Center LLC | 79ad55eb-b59d-4bb8-88e3-3b51e10a7f28 | 2023-11-15 | Warnings | M017 |
| PURE EASE Joint Muscle lnstant Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | 42bf129c-5c84-4331-b6d0-78e3be71a985 | 2023-11-13 | Warnings | M017 |
| PURE EASE Neur Cream Instant Deep Pain Relief | CAPSAICIN, MENTHOL | SERENU, INC. | e46a4636-6405-440a-a05a-862c354bab54 | 2023-11-13 | Warnings | M017 |
| Cryomax Cooling | MENTHOL | LIFE WEAR TECHNOLOGIES | 0a0ae5ba-9fac-45f6-e063-6294a90ad555 | 2023-11-13 | Warnings | M017 |
| LBri Super Aloe Stop The Pain | METHYL SALICYLATE, MENTHOL, CAPSAICIN | L'Bris, Pure 'N Natural | 8fb2010c-c34b-4552-858d-a0188ad313ad | 2023-11-11 | Warnings | M017 |
| TOTAL RELIEF | HYDROCORTISONE | DR. MARDER SKINCARE, LLC | 2c05459c-5a2c-45ab-b534-87f966b41681 | 2023-11-11 | Warnings | M017 |
| Human Science Muscle Pain Relief | METHYL SALICYLATE, MENTHOL | Human Science, LLC | 4bccc017-264b-11ce-e054-00144ff8d46c | 2023-11-11 | Warnings | M017 |
| Lidozen | LIDOCAINE HYDROCHLORIDE, MENTHOL | Village Pharma, LLC | 55108ffd-d6a8-41de-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| Debbies Down and Dirty Deep Tissue Joint and Muscle | MENTHOL | DD&D Manufacturing Co., Ltd | 531fe834-53e3-305f-e054-00144ff88e88 | 2023-11-11 | Warnings | M017 |
| TerraFreeze Pain Relief | MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE | Beyond Derma, LLC | 81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677 | 2023-11-11 | Warnings | M017 |
| GOLD ICE Pain Relief | MENTHOL | Eden's Answers, Inc. | a1356c39-42b9-4bd8-a873-bcd40717058b | 2023-11-11 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61010-8201-0 | 61010820100 | .059 L in 1 BOTTLE, SPRAY (61010-8201-0) | 2018-09-01 | 0000-00-00 | No | No | Current |