EMU THERAPY Cool Menthol Therapy Pain Relief Cream
- Product NDC
- 83591-416
- 11-digit product format
- 835910416
- Labeler code
- 83591
- Product ID
- 83591-416_097667a6-8c92-70ba-e063-6294a90a7af0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ACA MANAGEMENT LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-08-08
- Substance
- MENTHOL
- Active strength
- 27.5 mg/mL
- 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
- EMU THERAPY Cool Menthol Therapy Pain Relief Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 27.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2643471 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 16894346-3513-41b1-b09f-72d84edcc4ac | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83591-416-00 | EMU THERAPY Cool Menthol Therapy Pain Relief Cream | 237 mL in 1 JAR | CREAM | 237 | 4 |
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 |
|---|---|---|---|---|---|---|
| Burn First Aid | BURN FIRST AID | Dynarex Corporation | 826e08be-dffa-5a27-e053-2a91aa0a8701 | 2024-01-22 | Warnings | M017 |
| Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On | MENTHOL | TARGET CORPORATION | 0f95fc55-8665-9e89-e063-6394a90a7891 | 2024-01-22 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief Plus Menthol | LIDOCAINE, MENTHOL, UNSPECIFIED FORM | Natural Essentials, Inc. | 77978069-a1b4-473e-83c9-8320e00eea89 | 2024-01-19 | Warnings | M017 |
| ZIMS MAX FREEZE LEG CRAMPS | CAMPHOR, MENTHOL | KOBAYASHI Healthcare International, Inc. | ba26635d-95d3-4d88-93cc-1fd4fd29fd79 | 2024-01-18 | Warnings | M017 |
| Burn | LIDOCAINE | HART Health | e95ebdac-9789-41c2-97da-2307e4538794 | 2024-01-18 | Warnings | M017 |
| Medi-First Hydrocortisone 1% | HYDROCORTISONE ACETATE | Unifirst First Aid Corporation | bd216f5d-f304-7d8d-e053-2a95a90aa9ce | 2024-01-17 | Warnings | M017 |
| Green Guard Hydrocortisone 1% | HYDROCORTISONE | Unifirst First Aid Corporation | bd348e2a-57b1-3f17-e053-2a95a90a8bdc | 2024-01-17 | Warnings | M017 |
| Pain Relief | LIDOCAINE, MENTHOL | HUMN Pharmaceuticals Inc | 6c96f94a-e724-eab3-e053-2991aa0aab88 | 2024-01-17 | Warnings | M017 |
| CVS Health Lidocaine Pain Relief | LIDOCAINE | Natural Essentials, Inc. | 52e82e70-53b7-4ecb-be39-fe10c94cc444 | 2024-01-17 | Warnings | M017 |
| CVS Health XL Lidocaine Pain Relief | LIDOCAINE | NATURAL ESSENTIALS, INC. | ec16da91-8244-402b-b8d8-84896094ac2c | 2024-01-17 | Warnings | M017 |
| Anti-itch | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Target Corporation | f444b0a6-2ed3-4236-8206-342150290675 | 2024-01-17 | Warnings | M017 |
| Maximum Strength Hydrocortisone Anti-itch | HYDROCORTISONE 1% | Target Corporation | 4ff39cb8-3a20-4fe7-9829-1e882a484668 | 2024-01-17 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | eca272cb-ac8f-982b-e053-2995a90aa8b2 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cfde0-c463-e9b5-e053-2a95a90a1924 | 2024-01-15 | Warnings | M017 |
| American Safety and First Aid | HYDROCORTISONE ACETATE | Orazen Inc | eb0cce4b-c70a-1b2d-e053-2995a90aa4aa | 2024-01-15 | Warnings | M017 |
| Oral Pain Relief Gel | BENZOCAINE 20% | Sled Distribution, LLC | e7391302-831e-14dc-e053-2a95a90ac236 | 2024-01-15 | Warnings | M017 |
| FIRST SHIELD | LIDOCAINE HCI | Ever Ready First Aid | e022bf8f-3dd8-de22-e053-2995a90a219b | 2024-01-15 | Warnings | M017 |
| Flexigen | MENTHOL 1.25% | Derma Care Research Labs, LLC | e9ae2682-59b4-e796-e053-2995a90af921 | 2024-01-15 | Warnings | M017 |
| Vita-P Oral and Nasal | MENTHOL 1% | Beijing HKKY Medical Tech. Co., Ltd. | 537c3843-1c92-41c6-b724-52701bbddeab | 2024-01-13 | Warnings | M017 |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief | LIDOCAINE HYDROCHLORIDE | FSA Store Inc. | 0ec20c87-1681-dd23-e063-6394a90a291c | 2024-01-12 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2643471 | menthol 2.75 % Topical Cream | PSN | 16894346-3513-41b1-b09f-72d84edcc4ac | 4 |
| 2643471 | menthol 27.5 MG/ML Topical Cream | SCD | 16894346-3513-41b1-b09f-72d84edcc4ac | 4 |
| 2643471 | menthol 2.75 % Topical Cream | SY | 16894346-3513-41b1-b09f-72d84edcc4ac | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83591-416-00 | 83591041600 | 237 mL in 1 JAR (83591-416-00) | 237 ml | 2023-08-08 | No | No | Current |