Is Mentholatum Company, The FDA approved?

Mentholatum Company, The holds 5 FDA-registered establishments across 4 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Mentholatum Company, The's drugs manufactured?

At registered sites in China, Japan, the United States, Vietnam. The FDA register lists Zhongshan; Iga; Horsham, PA; Orchard Park, NY; Thuan Giao Ward. Registered operations: analytical testing, labelling, finished drug manufacture, repackaging.

What drugs does Mentholatum Company, The make?

108 products are listed under Mentholatum Company, The in the openFDA NDC Directory, most often as stick; liquid; ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mentholatum Company, The

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 5
Active NDC listings: 108
Live patents: 0
Countries: 4
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture4Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mentholatum (China) Pharmaceuticals Co., Ltd.Registrant: Mentholatum Company, The	Second Industrial Zone, Sanxiang, Zhongshan, Guangdong 528463, China (CHN)	Finished drug manufacture	3000188423420786030
Rohto Pharmaceutical Co., Ltd.Registrant: Mentholatum Company, The	7-3, Yumegaoka, Iga, Mie 518-0131, Japan (JPN)	Finished drug manufacture	3003722237696604024
Mentholatum Company, The	111 Rock Road, Horsham, Pennsylvania (PA) 19044, United States (USA)	Analytical testing	3005202366090691122
Mentholatum Company, The	707 Sterling Drive, Orchard Park, New York (NY) 14127, United States (USA)	Labelling, Finished drug manufacture, Repackaging	3000717606002105757
ROHTO-MENTHOLATUM (VIETNAM) CO., LTD.Registrant: Mentholatum Company, The	No. 16 VSIP Street No. 5, Vietnam - Singapore Industrial Park, Thuan Giao Ward, Ho Chi Minh 70000, Vietnam (VNM)	Finished drug manufacture	3008808745555347535

Catalogue

Drug listings by form and route

108

108 active NDC listings: 108 human otc drug. By marketing category: OTC MONOGRAPH DRUG 108.

Dosage form	NDCs
stick	27
liquid	17
ointment	17
gel	13
cream	12
lotion	7
patch	4
swab	4
cloth	3
for solution	2
kit	1
solution	1

Route	NDCs
topical	97
ophthalmic	10

Labeller name on the listing	NDCs
the mentholatum company	108

Catalogue

Marketed products

108

Brand	Generic name	Form / route	NDC
Cold and Hot Medicated	Menthol	patch, topical	10742-1117OTC MONOGRAPH DRUG
Cold and Hot Medicated	Menthol	patch, topical	10742-1118OTC MONOGRAPH DRUG
Mentholatum Cherry Vaporizing Rub	camphor, eucalyptus oil, menthol	ointment, topical	10742-8731OTC MONOGRAPH DRUG
Mentholatum Deep Heating Rub Extra Strength	menthol, methyl salicylate	cream, topical	10742-2002OTC MONOGRAPH DRUG
Mentholatum Heel Revival Cream	Mentholatum Heel Revival Cream	cream, topical	10742-0020OTC MONOGRAPH DRUG
Mentholatum Lavender Vaporizing Rub	camphor, eucalyptus oil, menthol	ointment, topical	10742-2112OTC MONOGRAPH DRUG
Mentholatum Lidocaine Heat	Lidocaine HCl	cream, topical	10742-8386OTC MONOGRAPH DRUG
Mentholatum Lidocaine Ice	Lidocaine HCl, Menthol	gel, topical	10742-1389OTC MONOGRAPH DRUG
Mentholatum Medicated Lip Balm Cherry	dimethicone, octinoxate, octisalate	ointment, topical	10742-8893OTC MONOGRAPH DRUG
Mentholatum Medicated Lip Balm Original	dimethicone, octinoxate, octisalate	ointment, topical	10742-8865OTC MONOGRAPH DRUG
Mentholatum Moisturizing Hand Sanitizer	benzalkonium chloride	gel, topical	10742-0004OTC MONOGRAPH DRUG
Mentholatum Natural Ice - Original, SPF 15 Original	dimethicone, octinoxate, octisalate	stick, topical	10742-3070OTC MONOGRAPH DRUG
Mentholatum Natural Ice Cherry	dimethicone, octinoxate, octisalate	stick, topical	10742-1048OTC MONOGRAPH DRUG
Mentholatum Natural Ice Cherry, SPF 15 Cherry	dimethicone, octinoxate, octisalate	stick, topical	10742-3075OTC MONOGRAPH DRUG
Mentholatum Natural Ice Original	dimethicone, octinoxate, octisalate	ointment, topical	10742-3004OTC MONOGRAPH DRUG
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30	avobenzone, dimethicone, octinoxate, octisalate	stick, topical	10742-3080OTC MONOGRAPH DRUG
Mentholatum Natural Ice Sport SPF 30	avobenzone, dimethicone, octinoxate, octisalate	ointment, topical	10742-8980OTC MONOGRAPH DRUG
Mentholatum Nighttime Vaporizing Rub	camphor, eucalyptus oil, menthol	ointment, topical	10742-8168OTC MONOGRAPH DRUG
Mentholatum No Mess Vaporizing Rub	camphor, eucalyptus oil, menthol	ointment, topical	10742-8096OTC MONOGRAPH DRUG
Mentholatum Original	camphor, menthol	ointment, topical	10742-0002OTC MONOGRAPH DRUG
Mentholatum Pain Relieving	menthol, methyl salicylate	lotion, topical	10742-8169OTC MONOGRAPH DRUG
Mentholatum Soothing Vapor Rub Cherry	Camphor, Eucalyptus Oil, Menthol	ointment, topical	10742-1062OTC MONOGRAPH DRUG
Mentholatum Soothing Vapor Rub Lavender	Camphor, Eucalyptus Oil, Menthol	ointment, topical	10742-1060OTC MONOGRAPH DRUG
Mentholatum Vapor Max	Camphor, Eucalyptus Oil, Menthol	ointment, topical	10742-1064OTC MONOGRAPH DRUG
OXY 10 Acne Cleanser	benzoyl peroxide	cream, topical	10742-1397OTC MONOGRAPH DRUG
OXY 3 in 1 Acne Pads	salicylic acid	swab, topical	10742-4359OTC MONOGRAPH DRUG
OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADS	salicylic acid	swab, topical	10742-1000OTC MONOGRAPH DRUG
OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADS	salicylic acid	swab, topical	10742-1200OTC MONOGRAPH DRUG
OXY Advanced Care Sensitive Skin Acne Cleanser	Benzoyl Peroxide	gel, topical	10742-1203OTC MONOGRAPH DRUG
OXY Advanced Care Soothing Cream Acne Cleanser	benzoyl peroxide	gel, topical	10742-1202OTC MONOGRAPH DRUG
OXY Advanced Care Soothing Cream Acne Cleanser	benzoyl peroxide	gel, topical	10742-1206OTC MONOGRAPH DRUG
OXY Deep Pore Cleansing Pads	salicylic acid	swab, topical	10742-4204OTC MONOGRAPH DRUG
OXY Rapid Spot Treatment Maximum Action	benzoyl peroxide	cream, topical	10742-1301OTC MONOGRAPH DRUG
OXY Sensitive Face Wash Maximum Soothing	Benzoyl Peroxide	lotion, topical	10742-1313OTC MONOGRAPH DRUG
OXY Volcanic Ash Acne Face Wash	Salicylic acid	liquid, topical	10742-8334OTC MONOGRAPH DRUG
OXY Volcanic Clay Acne Wash	Salicylic acid	cream, topical	10742-8338OTC MONOGRAPH DRUG
Oxy 10 Tinted	benzoyl peroxide	lotion, topical	10742-8354OTC MONOGRAPH DRUG
Oxy 10 Vanishing	benzoyl peroxide	lotion, topical	10742-8353OTC MONOGRAPH DRUG
Oxy 3-IN-1 Acne Cleansing Pads	Salicylic acid 2%	cloth, topical	10742-1008OTC MONOGRAPH DRUG
Oxy 3-IN-1 Acne Cleansing Pads	salicylic acid	for solution, topical	10742-1010OTC MONOGRAPH DRUG
Oxy 5 Tinted	benzoyl peroxide	lotion, topical	10742-8356OTC MONOGRAPH DRUG
Oxy 5 Vanishing	benzoyl peroxide	lotion, topical	10742-8355OTC MONOGRAPH DRUG
Oxy Advanced Care Rapid Spot Treatment	benzoyl peroxide	gel, topical	10742-1201OTC MONOGRAPH DRUG
Oxy Advanced Care Rapid Spot Treatment	benzoyl peroxide	gel, topical	10742-1205OTC MONOGRAPH DRUG
Oxy Deep Pore Acne Cleansing Pads	Salicylic acid 2%	cloth, topical	10742-1006OTC MONOGRAPH DRUG
Oxy Deep Pore Acne Cleansing Pads	salicylic acid	for solution, topical	10742-1011OTC MONOGRAPH DRUG
Oxy Hydrating Anti-Blemish Body Wash	Oxy Hydrating Anti-Blemish Body Wash	gel, topical	10742-1009OTC MONOGRAPH DRUG
Oxy Maximum Strength Acne Cream Cleanser	Oxy Maximum Strength Acne Cream Cleanser	cream, topical	10742-1003OTC MONOGRAPH DRUG
Oxy Maximum Strength Rapid Spot Treatment	Oxy Maximum Strength Rapid Spot Treatment	cream, topical	10742-1002OTC MONOGRAPH DRUG
Oxy Sensitive Skin Acne Cleansing Pads	Salicylic acid 0.5%	cloth, topical	10742-1007OTC MONOGRAPH DRUG
Oxy Sensitive Skin Acne Cream Cleanser	Benzoyl peroxide 5%	cream, topical	10742-1004OTC MONOGRAPH DRUG
Oxy Total Care Clarifying Moisturizer	benzoyl peroxide	lotion, topical	10742-1314OTC MONOGRAPH DRUG
Oxy Total Care Creamy Facial Cleanser	salicylic acid	cream, topical	10742-1316OTC MONOGRAPH DRUG
Oxy Total Care Vitamin C Serum	salicylic acid	solution, topical	10742-1315OTC MONOGRAPH DRUG
Oxy Vitamin C Serum	Salicylic acid 0.5%	liquid, topical	10742-1005OTC MONOGRAPH DRUG
Phisoderm Anti Blemish Body Wash	Salicylic Acid	liquid, topical	10742-8451OTC MONOGRAPH DRUG
Phisoderm Anti-Blemish Gel Cleanser	Salicylic acid	gel, topical	10742-8417OTC MONOGRAPH DRUG
Phisoderm Clear Confidence Spot Treatment	benzoyl peroxide	cream, topical	10742-8293OTC MONOGRAPH DRUG
Red Cross Canker Sore	benzocaine	ointment, topical	10742-8915OTC MONOGRAPH DRUG
Red Cross Oral Pain Relief	benzocaine	liquid, topical	10742-8902OTC MONOGRAPH DRUG
Red Cross Toothache	eugenol	liquid, topical	10742-0009OTC MONOGRAPH DRUG
Rohto All-In-One	Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate	liquid, ophthalmic	10742-8146OTC MONOGRAPH DRUG
Rohto Cool	Naphazoline hydrochloride, Polysorbate 80	liquid, ophthalmic	10742-8142OTC MONOGRAPH DRUG
Rohto Cool Relief	Naphazoline hydrochloride, Polysorbate 80	liquid, ophthalmic	10742-8141OTC MONOGRAPH DRUG
Rohto Digi-Eye	Hypromellose, Tetrahydrozoline hydrochloride	liquid, ophthalmic	10742-8175OTC MONOGRAPH DRUG
Rohto Dry-Aid	povidone, propylene glycol	liquid, ophthalmic	10742-8162OTC MONOGRAPH DRUG
Rohto Dual Light Relief	Hypromellose, Povidone	liquid, ophthalmic	10742-8459OTC MONOGRAPH DRUG
Rohto Max Strength	Naphazoline hydrochloride, Polysorbate 80	liquid, ophthalmic	10742-8158OTC MONOGRAPH DRUG
Rohto Optic Glow	Naphazoline hydrochloride, Povidone, Propylene glycol	liquid, ophthalmic	10742-8160OTC MONOGRAPH DRUG
Rohto Preservative Free Dry Aid	povidone, propylene glycol	liquid, ophthalmic	10742-8161OTC MONOGRAPH DRUG
Rohto Sun and Sport	hypromellose, povidone	liquid, ophthalmic	10742-8140OTC MONOGRAPH DRUG
Softlips Cherry	dimethicone, octinoxate, octisalate, oxybenzone	ointment, topical	10742-8512OTC MONOGRAPH DRUG
Softlips Cherry Cordial, Maple Butter, Frosted Berry	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-7001OTC MONOGRAPH DRUG
Softlips Cherry, Raspberry, Vanilla	dimethicone	stick, topical	10742-7002OTC MONOGRAPH DRUG
Softlips Marshmallow Ghost	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-8510OTC MONOGRAPH DRUG
Softlips Naturals Medicated	Camphor, Menthol	stick, topical	10742-8481OTC MONOGRAPH DRUG
Softlips Naturals Medicated Elderberry Acai	Camphor, Menthol	stick, topical	10742-8482OTC MONOGRAPH DRUG
Softlips Naturals Medicated Matcha Honey	Camphor, Menthol	stick, topical	10742-8480OTC MONOGRAPH DRUG
Softlips Oasis Pineapple Coconut	dimethicone, oxybenzone, octinoxate	stick, topical	10742-8745OTC MONOGRAPH DRUG
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi	dimethicone, oxybenzone, octinoxate	stick, topical	10742-8744OTC MONOGRAPH DRUG
Softlips Oasis Watermelon Blackberry	dimethicone, oxybenzone, octinoxate	stick, topical	10742-8747OTC MONOGRAPH DRUG
Softlips Peach Passion	dimethicone	stick, topical	10742-7006OTC MONOGRAPH DRUG
Softlips Pearl	octinoxate, octisalate	stick, topical	10742-8573OTC MONOGRAPH DRUG
Softlips Pearl Plus Vanilla	dimethicone, octinoxate, octisalate, oxybenzone	kit	10742-7011OTC MONOGRAPH DRUG
Softlips Peppermint	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-8517OTC MONOGRAPH DRUG
Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-7010OTC MONOGRAPH DRUG
Softlips Peppermint Swirl	dimethicone	stick, topical	10742-8518OTC MONOGRAPH DRUG
Softlips Raspberry	dimethicone, octinoxate, octisalate, oxybenzone	ointment, topical	10742-8470OTC MONOGRAPH DRUG
Softlips Salted Caramel, Candy Apple, Marshmallow Ghost	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-7004OTC MONOGRAPH DRUG
Softlips Tropical Coconut	dimethicone	stick, topical	10742-7007OTC MONOGRAPH DRUG
Softlips Tropical Coconut Peach Passion	dimethicone	stick, topical	10742-7005OTC MONOGRAPH DRUG
Softlips Vanilla	dimethicone, octinoxate, octisalate, oxybenzone	ointment, topical	10742-3051OTC MONOGRAPH DRUG
Softlips Vanilla	dimethicone	stick, topical	10742-8508OTC MONOGRAPH DRUG
Softlips Vanilla Watermelon	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-8477OTC MONOGRAPH DRUG
Softlips Vanilla Watermelon	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-8478OTC MONOGRAPH DRUG
Softlips Vanilla, Watermelon, Cherry	dimethicone, octinoxate, octisalate, oxybenzone	ointment, topical	10742-7009OTC MONOGRAPH DRUG
Softlips Watermelon	dimethicone	stick, topical	10742-7008OTC MONOGRAPH DRUG
Softlips Watermelon	dimethicone, octinoxate, octisalate, oxybenzone	stick, topical	10742-8476OTC MONOGRAPH DRUG
Softlips Watermelon, Tropical Coconut, Peach Passion	dimethicone	stick, topical	10742-7003OTC MONOGRAPH DRUG
Ultra Strength Muscle Rub	Camphor, Menthol, Methyl salicylate	cream, topical	10742-6000OTC MONOGRAPH DRUG
WellPatch Cooling Pain Relief	menthol	patch, topical	10742-8125OTC MONOGRAPH DRUG
WellPatch Warming Pain Relief	capsaicin	patch, topical	10742-8127OTC MONOGRAPH DRUG
pHisoderm CLEAN ANTI-BLEMISH BODY WASH	Salicylic Acid	gel, topical	10742-1234OTC MONOGRAPH DRUG
pHisoderm CLEAN ANTI-BLEMISH BODY WASH	Salicylic Acid	gel, topical	10742-1236OTC MONOGRAPH DRUG
pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSER	Salicylic Acid	gel, topical	10742-1235OTC MONOGRAPH DRUG
pHisoderm Clear Confidence Body Wash	Salicylic Acid	liquid, topical	10742-1442OTC MONOGRAPH DRUG
pHisoderm Clear Confidence Daily Gel Face Wash	Salicylic acid	liquid, topical	10742-1412OTC MONOGRAPH DRUG
pHisoderm Clear Confidence Face Scrub	Salicylic acid	gel, topical	10742-1233OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Akeso Biopharma Co., LtdZhongshan, CHN · 2 sites
Ferring Pharmaceuticals Inc.Zhongshan, CHN
Endo USA, Inc.Horsham, PA
Eurofins S-F Analytical Laboratories, Inc.Horsham, PA
National Medical Services, Inc. dba NMS LabsHorsham, PA
Guangdong Longfu Medicine Co LtdZhongshan, CHN
Pharmaceutical Manufacturing Research ServicesHorsham, PA

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Enquiry

Common questions

Is Mentholatum Company, The FDA approved?: Mentholatum Company, The holds 5 FDA-registered establishments across 4 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Mentholatum Company, The's drugs manufactured?: At registered sites in China, Japan, the United States, Vietnam. The FDA register lists Zhongshan; Iga; Horsham, PA; Orchard Park, NY; Thuan Giao Ward. Registered operations: analytical testing, labelling, finished drug manufacture, repackaging.
What drugs does Mentholatum Company, The make?: 108 products are listed under Mentholatum Company, The in the openFDA NDC Directory, most often as stick; liquid; ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.