Cool and Heat Sore Muscle Roller
- Product NDC
- 80551-002
- 11-digit product format
- 805510002
- Labeler code
- 80551
- Product ID
- 80551-002_d5cc85eb-9d2b-30f4-e053-2995a90ad79a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Acutens
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2021-03-10
- Marketing end
- 0000-00-00
- Substance
- MENTHOL
- Active strength
- 16 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | 80551-002 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 80551-002 | 80551-002-02 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80551-002-02 | 80551000202 | 70.8 g in 1 CONTAINER (80551-002-02) | 70.8 g | 2021-03-10 | 0000-00-00 | No | No | Current |