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 147 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GeriGentle FrostyHeat Pain Relief Patch Back	MENTHOL	Geri-Gentle Corporation	e442b8ec-a3de-65e8-e053-2995a90af3ec	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	9f948fb4-4275-4a1f-83f8-cd708db4a296	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF PAIN RELIEF	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	b4278b70-e9a6-4d1f-bbad-257fe437b86a	2023-11-10	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain Relief	MENTHOL, CAPSAICIN	BLUE SPRING WELLNESS, L.L.C.	2f9cf514-48be-49ec-b424-0b228b4b874a	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	1231ddd2-7661-45b2-ab15-32f7fdc078a8	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE Stuff Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	7779b26b-ae3b-4639-a6b0-826c7ab37a86	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4	2023-11-10	Warnings	Exact identifier application number: M017
SUPER BLUE STUFF Pain Relief Cream	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	066a2106-2e25-4df6-9a8d-4417ba190205	2023-11-10	Warnings	Exact identifier application number: M017
INVIGO FLEX Pain Relief Gel	MENTHOL	WYNNPHARM INC.	909e1d8c-c517-4d6a-8682-894f042c00f8	2023-11-10	Warnings	Exact identifier application number: M017
ARNIMAX Penetrating Pain Relief Gel	MENTHOL	WYNNPHARM INC.	3a31f805-19c6-4036-a663-ebef9b212007	2023-11-10	Warnings	Exact identifier application number: M017
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Exact identifier application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVING	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	da004500-5e48-487b-b96f-520a3094096c	2023-11-10	Warnings	Exact identifier application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
NEUROFLEX Topical Pain Relieving Liquid	CAMPHOR (SYNTHETIC), MENTHOL	Almark Products Inc	6da3aa84-7a01-4041-8792-a4bbf49e6e4e	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR 60-second Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	3b74b542-202f-469e-8025-4372e95e6b01	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f8b8d1-a20b-54b0-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f92e71-fe2e-16f4-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M017
Teeter Renew Muscles Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	b90dc5b9-c31d-4770-a291-98d036ae8723	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR Foot and Leg Rub	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	57094238-506b-48c1-8eb9-fe904be80df0	2023-11-10	Warnings	Exact identifier application number: M017
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	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