Freeze Ease Max Cream
- Product NDC
- 87843-313
- 11-digit product format
- 878430313
- Labeler code
- 87843
- Product ID
- 87843-313_18e60a51-3d24-4570-b2a5-99dc2ecb2bd1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol 10.5%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Global America Group LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-01
- Substance
- MENTHOL, UNSPECIFIED FORM
- Active strength
- 10.5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 87843-313 | D | Discontinued by firm | 2026-10-23 | ||
| excluded package | package | 87843-313 | 87843-313-95 | D | Discontinued by firm | 2026-10-23 |
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
- Freeze Ease Max Cream
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL, UNSPECIFIED FORM | 10.5 g/100g |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Cool n Heat | COOL N HEAT | NeilMed Pharmaceuticals, Inc. | a24cde17-280b-8358-e053-2a95a90af67d | 2024-01-11 | Warnings | M017 |
| NeilMed Anti-Itch | ANTI-ITCH SPRAY | NeilMed Pharmaceuticals Inc. | b3d34d9e-85d9-df4e-e053-2a95a90ac8d9 | 2024-01-11 | Warnings | M017 |
| NeilMed Hot and Cold Pain Relief | PAIN RELIEF SPRAY | NeilMed Pharmaceuticals Inc. | b3d02111-7499-c2d4-e053-2a95a90ae1de | 2024-01-11 | Warnings | M017 |
| Cooling Itch Relief | COOLING ITCH RELIEF | NeilMed Pharmaceuticals, Inc | a24bdea0-18e8-8a5e-e053-2995a90acea2 | 2024-01-11 | Warnings | M017 |
| Lightning X Burn | LIDOCAINE | Nantong Health & Beyond Hygienic Products Inc. | 0e69a971-0c6e-6ebe-e063-6394a90a0b33 | 2024-01-08 | Warnings | M017 |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics | LIDOCAINE HYDROCHLORIDE | AVADIM HOLDINGS, INC. | e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 | 2024-01-08 | Warnings | M017 |
| 2nd CHANCE MOBILITY Pain Relief | HISTAMINE DIHYDROCHLORIDE | ALPHA NUTRITION, LLC | 575097ac-9fc9-4391-99d1-dff9b34817e3 | 2024-01-08 | Warnings | M017 |
| Tiger Balm Arthritis Rub | CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM | Haw Par Healthcare Ltd. | 80932288-4797-40d3-aa8a-6af686fb67ad | 2024-01-08 | Warnings | M017 |
| OPRAVA | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Biological M.D. Solutions LLC | 05552560-e283-5eba-e063-6294a90a65f7 | 2024-01-06 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87843-313-12 | 87843031312 | 120 g in 1 BOTTLE, PUMP (87843-313-12) | 120 g | 2026-09-01 | No | No | Current |