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 147 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	Warnings	Exact identifier application number: M017
EMU THERAPY Red Hot Pepper Pain Relief Cream	MENTHOL, CAPSAICIN	ACA MANAGEMENT LLC	36293885-b2dd-4fba-9748-35a3c9e05078	2023-11-06	Warnings	Exact identifier application number: M017
ROPANA Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	FUSION PAIN SOLUTIONS LLC	e0342aa3-ca80-40b7-bec6-1b33c4db398b	2023-11-06	Warnings	Exact identifier application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief Cream	MENTHOL	ACA MANAGEMENT LLC	16894346-3513-41b1-b09f-72d84edcc4ac	2023-11-06	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	0db91010-12f7-4f20-b96c-432915720d5a	2023-11-06	Warnings	Exact identifier application number: M017
POWERECT Lidocaine Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	42e0c40f-1efd-45ef-815d-53d193d720eb	2023-11-06	Warnings	Exact identifier application number: M017
ARTHRO LIFE Instant Pain Relief Cream	MENTHOL	BIOBEST SERVICES LLC	66eb1a78-6861-4693-b68e-bd4a664fc075	2023-11-06	Warnings	Exact identifier application number: M017
PARACTIN QuantumActiv Pain Relief Cream	MENTHOL	NHR SCIENCE CORP	ae2f89cf-120c-4c6f-9e81-4560e6fa0373	2023-11-06	Warnings	Exact identifier application number: M017
FISICO Arthrozene Pain Cream	MENTHOL	FISICO INC.	d02c4349-78dd-4672-9582-50124ea9f1e1	2023-11-06	Warnings	Exact identifier application number: M017
BRONSON SOOTHE Pain Relief	CAPSAICIN	BRONSON NUTRITIONALS, LLC	cedf8f43-b9a3-4a06-b3a1-cf82668541f8	2023-11-06	Warnings	Exact identifier application number: M017
INTIMALE Benzocaine Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	b845bfd5-ab73-495f-97ef-e959bc6311d9	2023-11-06	Warnings	Exact identifier application number: M017
RAPID PAIN-RELIEF TOPICAL	LIDOCAINE HYDROCHLORIDE, MENTHOL	NORDIC HEALTHY LIVING INC.	a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870	2023-11-06	Warnings	Exact identifier application number: M017
PURE PERSONAL All Natural Pain Relief Cream	MENTHOL	PURE PERSONAL CARE, LLC	8f3fb1d0-d238-4b4c-9816-7e335258d71d	2023-11-06	Warnings	Exact identifier application number: M017
DIRT Pain Relieving Gel	MENTHOL	PURIVITAE, LLC	89c80a8f-227d-4ec0-9327-683892e73b6a	2023-11-06	Warnings	Exact identifier application number: M017
DIRT Pain Relieving Gel	MENTHOL	PURIVITAE, LLC	e43e2cbd-d114-4b11-8baf-7a775881cd97	2023-11-06	Warnings	Exact identifier application number: M017
Celadrin Joint and Muscle Pain Relieving	MENTHOL	Factors Group of Nutritional Products	6396e4b6-2130-433b-bdb3-97c76dbe685c	2023-11-06	Warnings	Exact identifier application number: M017
Atomic Balm	METHYL SALICYLATE, CAPSAICIN	The Hygenic Company, LLC	d10028f3-ae6a-7b01-e053-2995a90a5a84	2023-11-05	Warnings	Exact identifier application number: M017
HEMPCIN Advanced Topical Pain Relief Cream	MENTHOL	Pedicis Research, LLC	97f5e300-b780-4694-a681-60d5e0cfad65	2023-11-05	Warnings	Exact identifier application number: M017
Point Relief cold Spot Pain Relieving roll-on	MENTHOL	Fabrication Enterprises	3f1db0ad-aaa8-4e14-9349-45057e0fb4a6	2023-11-05	Warnings	Exact identifier application number: M017
LidoStat	LIDOCAINE HCL	Clinical Therapeutic Solutions	1825885b-9141-4515-bb69-a1c4a39fb10d	2023-11-05	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