MENTHOL, CAMPHOR

Product NDC: 80465-003
11-digit product format: 804650003
Labeler code: 80465
Product ID: 80465-003_137c6781-8bba-de23-e063-6394a90a6abb
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAMPHOR
Dosage form: CREAM
Route: TOPICAL
Labeler: EROS GLOBAL
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-11-04
Substance: MENTHOL; CAMPHOR (NATURAL)
Active strength: 3; 3 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: MENTHOL, CAMPHOR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	3 g/100g
CAMPHOR (NATURAL)	3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
N20HL7Q941	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2606068	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b3495c95-ba4b-9459-e053-2a95a90a710f	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80465-003-04	MENTHOL, CAMPHOR	113 g in 1 BOTTLE	CREAM	113		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80465-003	MENTHOL, CAMPHOR CREAM [EROS GLOBAL]	4	Current NDC, Legacy NDC, 1 package rows	20240321_b3495c95-ba4b-9459-e053-2a95a90a710f.zip

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.

Matched openFDA labels page 152 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Red hot	CAPSAICIN	The Hygenic Company, LLC	d100092c-e10b-2063-e053-2995a90aedb2	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	c8d4ae28-efc4-6a00-e053-2a95a90a40bf	2023-10-25	Warnings	Exact identifier application number: M017
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	3336cc35-e773-4705-84b5-61040604beef	2023-10-25	Warnings	Exact identifier application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant	BENZOCAINE, WHITE PETROLATUM	Carma Laboratories, Inc.	bbf0abcd-b7d6-b5e4-e053-2995a90a5240	2023-10-25	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bbee66b9-39ff-4e7e-e053-2995a90a43be	2023-10-25	Warnings	Exact identifier application number: M017
XtraCare Ice Cold Topical Analgesic Gel	MENTHOL	Rejoice International	d38f3099-d940-44d8-aa7f-404157c5e0e3	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fefbe351-1cd9-4a2f-a43d-51e2c4eb180b	2023-10-24	Warnings	Exact identifier application number: M017
TheraPlus Plus	MENTHOL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	d4119f84-eb60-4134-b58e-de13d9601199	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll- On- Lidocaine	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	b4ce3876-f9e3-43ca-810b-75fbe6f887b6	2023-10-23	Warnings	Exact identifier application number: M017
NUMOTIZINE	MENTHOL	Hobart Laboratories, Inc.	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	2023-10-20	Warnings	Exact identifier application number: M017
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier application number: M017
Liprotek	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5	2023-10-19	Warnings	Exact identifier application number: M017
GENUINE FIRST AID Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bc7c6739-6068-4694-adc9-0c0c5c347df4	2023-10-19	Warnings	Exact identifier application number: M017
CVS Itch relief moisturizing	PRAMOXINE HCL 1%	CVS Health	f3a753fc-f448-6bba-e053-2a95a90a8e1b	2023-10-18	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Asclemed USA, Inc.	e13984ea-73a9-2894-e053-2995a90a8ed6	2023-10-16	Warnings	Exact identifier application number: M017
EXOTEN-C	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Asclemed USA, Inc.	76ed37e0-64b5-4abe-a03c-3dc7084a3919	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo HP Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	89a8c267-bd92-4d0d-8e50-c52224aff9cd	2023-10-16	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2606068	camphor 3 % / menthol 3 % Topical Cream	PSN	b3495c95-ba4b-9459-e053-2a95a90a710f	4
2606068	camphor 30 MG/ML / menthol 30 MG/ML Topical Cream	SCD	b3495c95-ba4b-9459-e053-2a95a90a710f	4
2606068	camphor 3 % / menthol 3 % Topical Cream	SY	b3495c95-ba4b-9459-e053-2a95a90a710f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80465-003-04	80465000304	113 g in 1 BOTTLE (80465-003-04)	113 g	2020-11-04	0000-00-00	No	No	Current