Rohto-mentholatum (vietnam) Co., Ltd.: FDA regulatory signals
This page aggregates the United States FDA regulatory records that reference Rohto-mentholatum (vietnam) Co., Ltd. in the datasets indexed by this site. Across the ingested data, Rohto-mentholatum (vietnam) Co., Ltd. is associated with 8 recall record(s), 0 drug-shortage record(s), and 0 approval record(s). The most recent dated event attributed to this firm in the indexed data is a recall record dated 2026-07-29. These counts are coverage-limited activity signals derived only from the specific FDA datasets indexed here. They are NOT quality ratings, reputational scores, or judgements about the firm or its products. A higher or lower count reflects how often a firm appears in these particular public records over the ingested window — nothing more. Recalls and shortages are routine parts of pharmaceutical regulation, and their presence here is an administrative fact, not an indication of wrongdoing or of product danger. Use this page as a finding aid to locate the underlying FDA records, then verify every detail against the official source. This page contains regulatory information only and offers no medical advice.
Signal summary
| Recall records | 8 |
|---|---|
| Shortage records | 0 |
| Approval records | 0 |
| Most recent record date | 2026-07-29 |
| Most recent record type | recall |
These counts are not a quality rating. They are coverage-limited activity signals showing how often this firm appears in the indexed FDA recall and shortage records over the ingested window. They are not reputational scores or judgements about the firm or its products.
Recall records
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1 · Class II · 2026-07-29
- Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2 · Class II · 2026-07-29
Source limitations
This page is built only from the FDA recall and shortage records this site has ingested. It does not represent the firm's full regulatory history, its approvals, or any data held in sources not indexed here. The ingested window is finite and can lag the live FDA record, so counts and dates reflect a point in time. Every linked record points back to the verifiable official source; confirm details there. This page contains regulatory information only and offers no medical advice, no assessment of product safety, and no recommendation of any kind.
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages)
- Publication date
- Not available
- Ingested
- 2026-08-10
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.