PO SUM ON MEDICATED

Product NDC: 54155-052
11-digit product format: 541550052
Labeler code: 54155
Product ID: 54155-052_5d2fb4f7-1b53-3343-e063-6394a90a2cfb
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: OIL
Route: TOPICAL
Labeler: PO SUM ON MEDICINE FACTORY LIMITED
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-08-27
Marketing end: 2030-09-02
Substance: MENTHOL
Active strength: 15 g/100mL
NDC exclude flag: No
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: PO SUM ON MEDICATED

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	15 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54155-052-01	PO SUM ON MEDICATED	30 mL in 1 BOTTLE, GLASS	OIL	30	6
54155-052-01	PO SUM ON MEDICATED	1 in 1 CAN	OIL	1	6
54155-052-02	PO SUM ON MEDICATED	5.6 mL in 1 BOTTLE, GLASS	OIL	5.6	6
54155-052-02	PO SUM ON MEDICATED	1 in 1 BOX	OIL	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
CAMELLIA OIL	INACTIVE INGREDIENT	T1PE06G0VE	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
CINNAMON OIL	INACTIVE INGREDIENT	E5GY4I6YCZ	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
DAEMONOROPS DRACO RESIN	INACTIVE INGREDIENT	787Z7N9UCU	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
GLYCYRRHIZA URALENSIS WHOLE	INACTIVE INGREDIENT	8XW1DS8UIR	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2
SCUTELLARIA BAICALENSIS ROOT	INACTIVE INGREDIENT	7J95K7ID2S	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54155-052	PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20241127_7239a241-afbf-4877-8608-59dff8d16187.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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.Harry COMFORT ZONE Cream	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4d32b89f-72e8-bc93-e063-6394a90a0bc8	2026-03-17	Warnings	Exact identifier application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain Relief	CAPSAICIN, MENTHOL	Milo Rod Import & Export, Inc.	c3622dc3-0c05-47c9-b70b-498946781906	2026-03-17	Warnings	Exact identifier application number: M017
Walgreens Burn Pad	BURN PAD	Walgreens	3f8d7624-cf1e-1992-e063-6294a90a3806	2026-03-17	Boxed warning, Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Mericon Industries	8f351b04-8f6d-4353-9100-13a8a80d656a	2026-03-17	Warnings	Exact identifier application number: M017
Shoe Pain Relief	LIDOCAINE HCI 4%	Sole Amie	0f2ccd5f-b9f4-40fc-b82f-173b0f19bf40	2026-03-16	Warnings	Exact identifier application number: M017
CVS Muscle Balm	MENTHOL, CAMPHOR	CVS Health	42796fc4-03be-3b02-e063-6394a90af2ab	2026-03-16	Warnings	Exact identifier application number: M017
Crane Safety Hydrocortisone	HYDROCORTISONE	Crane Safety LLC	96d9527d-9bf7-ce82-e053-2995a90aff0c	2026-03-16	Warnings	Exact identifier application number: M017
CVS Health Pain Relief Foot	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	0f646876-69d0-49db-ade2-2b3eb26dd399	2026-03-16	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relief Foot Cream	MENTHOL	Walgreen Co.	3bc8ece3-d555-3efb-e063-6394a90a1981	2026-03-16	Warnings	Exact identifier application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOT	MENTHOL	RICHTOFIT LIMITED LIABILITY COMPANY	4c357696-ca96-e6ad-e063-6294a90aaadb	2026-03-16	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	348e6062-b31e-435e-a153-6aa868b50efa	2026-03-13	Warnings	Exact identifier application number: M017
DGH GREASELESS MUSCLE RUB ANALGESIC	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	DOLLAR GENERAL	225abfe0-ec72-4667-96b2-7657e989672b	2026-03-13	Warnings	Exact identifier application number: M017
CVS Professional Pain Relief	MENTHOL	CVS Pharmacy	48836a5b-0baa-b7ee-e063-6294a90ac12b	2026-03-13	Warnings	Exact identifier application number: M017
Keeps Climax Delay	LIDOCAINE HYDROCHLORIDE	Cosco International, Inc.	3bfd3173-2dac-40a9-aec3-982b1d47d8fa	2026-03-12	Warnings	Exact identifier application number: M017
NanoX Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	4cc38927-8a8c-2df3-e063-6294a90aa0c1	2026-03-12	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4cd4c51c-88bb-3797-e063-6294a90a8f70	2026-03-12	Warnings	Exact identifier application number: M017
CVS Lidocaine Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	CVS Pharmacy	48c045ae-56b5-62c2-e063-6394a90aaf44	2026-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4cd62cba-075a-7448-e063-6394a90ab48d	2026-03-12	Warnings	Exact identifier application number: M017
Medicated Pain Relief Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	Kroger Company	47cc4b05-a937-4624-bf41-85b8bd7c049e	2026-03-12	Warnings	Exact identifier application number: M017
Lidocaine HCL	LIDOCAINE HCL	Matthias Therapeutics, LLC	4cdb27b5-9178-0328-e063-6394a90a50b5	2026-03-12	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54155-052-01	54155005201	1 BOTTLE, GLASS in 1 CAN (54155-052-01) / 30 mL in 1 BOTTLE, GLASS	2026-08-27	2030-09-02	No	No	Current
54155-052-02	54155005202	1 BOTTLE, GLASS in 1 BOX (54155-052-02) / 5.6 mL in 1 BOTTLE, GLASS	2026-08-27	2030-09-02	No	No	Current