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 | 2026-10-16 | ||
| excluded package | package | 87843-313 | 87843-313-95 | D | Discontinued by firm | 2026-10-16 |
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.
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 |