THE MENTHOLATUM COMPANY

FDA Device Registration & Listing · ORCHARD PARK, NY, US · Registration 1320681

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1320681
FEI Number
3000717606
Entity Name
THE MENTHOLATUM COMPANY
City/State/Country
ORCHARD PARK, NY, US
Establishment Address
707 Sterling Dr, ORCHARD PARK, NY 14127, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
The Mentholatum Company (Owner Number: 1310248)
Owner / Operator Contact Address
707 Sterling Drive, --, Orchard Park, NY 14127, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Oxy Acne Care Patches Oxy Acne Care Hydrocolloid Patches WellPatch HEAT THERAPY PAIN RELIEF PATCH WellPatch MIGRAINE & HEADACHE Cooling Patch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MGO Closure, Wound, Adhesive General, Plastic Surgery Class 1 878.4018 2025-06-13
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2003-11-12

Official Correspondent

Charisse Bush

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Mentholatum Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003002183 Interthai Pharmaceutical Manufacturing Limited Bangkok, Chatuchak Krung Thep Maha Nakhon, TH
9615433 MENTHOLATUM (CHINA) PHARMACEUTICALS CO., LTD. GUANGDONG, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3015341499 Weihai Kangzheng Medical Equipments Technology Co.,Ltd weihai Shandong, CN
3027328721 HANGZHOU YUNCHI TECHNOLOGY CO., LTD Hangzhou Zhejiang, CN
3016615875 STYMCO MEDICAL LLC Tampa, FL, US
3008406960 UNIVERSAL CONTAINER & PACKAGING Chino, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1320681. Last updated year: 2026. Please use registration number 1320681 when referencing this establishment in official correspondence.
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