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 144 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUBBING DOTS NATURAL COOL PAIN RELIEF	MENTHOL	Awesome Trading, LLC	137a88ff-e409-4a67-addc-883194c356ae	2023-11-11	Warnings	Exact identifier application number: M017
MAXOCAINE Lidocaine Hemp Oil Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Prime Commerce, LLC	28ed2149-38d2-4062-8442-990a98a69cfc	2023-11-11	Warnings	Exact identifier application number: M017
MAXOCAINE PAIN RELIEVING ROLL-ON	LIDOCAINE HYDROCHLORIDE, MENTHOL	Prime Commerce, LLC	c263d5f2-89b9-4dfd-91c8-f894e5f956c9	2023-11-11	Warnings	Exact identifier application number: M017
SUGAR BRANDS Rescue Pain Relief and Recovery	LIDOCAINE HYDROCHLORIDE	Sugar Brands, LLC	74013709-d1d5-4425-825d-eee726718c61	2023-11-11	Warnings	Exact identifier application number: M017
NATURES CRAFT LIDOCAINE Male Genital Desensitizer	LIDOCAINE HYDROCHLORIDE	Natures Design Products LLC	61bf1776-5c6c-4307-8348-41fa60164017	2023-11-11	Warnings	Exact identifier application number: M017
CLEAN REMEDIES CR PAIN RELIEF	MENTHOL	Clean Remedies, LLC	aea9291d-3244-401c-9607-e91107228faa	2023-11-11	Warnings	Exact identifier application number: M017
Arth Arrest	METHYL NICOTINATE, CAPSAICIN	Key 2 Health, Inc.	495034ac-dbf5-4c55-906b-6ffcbcfd5bc2	2023-11-11	Warnings	Exact identifier application number: M017
KINETIC ICE Muscle and Joint Pain Relief Cream	MENTHOL	No Reason, LLC	565f0e20-e534-41db-ba20-e726d578405f	2023-11-11	Warnings	Exact identifier application number: M017
KARMA RUB Elemental Pain Relief	LIDOCAINE HYDROCHLORIDE	Elemental Bliss LLC	c224fb1b-827f-461e-a58f-4020700c3e0d	2023-11-11	Warnings	Exact identifier application number: M017
Bakers Best Arthritis Pain Relief with Hemp Seed	HISTAMINE DIHYDROCHLORIDE	Baker's Best Health Products, LLC	46415d28-99b5-4c9e-bde9-1c703595f671	2023-11-11	Warnings	Exact identifier application number: M017
Dr PAINES Pain Relief	MENTHOL	DOCTOR PAINE'S MEDICAL, LLC	79d2b332-051e-48c1-afe8-6d4468cd1878	2023-11-11	Warnings	Exact identifier application number: M017
INTIMALE Maximum Strength Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25b9ade3-72b0-4b86-8c48-90310a26806f	2023-11-11	Warnings	Exact identifier application number: M017
POWERECT Max Power Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25a1c926-9543-44a7-865e-a4b6e1a40cbe	2023-11-11	Warnings	Exact identifier application number: M017
SKINS DELAY Maximum Strength Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	172efe5d-28b8-443c-b3f9-429669189081	2023-11-11	Warnings	Exact identifier application number: M017
GASPARI Ageless Pain Relief Cream	MENTHOL	GASPARI ANTI-AGING LLC	ea806089-688b-4944-ad69-86f366509eb5	2023-11-11	Warnings	Exact identifier application number: M017
ZENSEZONE Arthmed Temporary Pain Relief Cream	CAPSAICIN, MENTHOL, METHYL SALICYLATE	ZENSEZONE LLC	c5778f22-c411-4bd7-b2af-45e3fee15fd2	2023-11-11	Warnings	Exact identifier application number: M017
PRFC HEMP Topical Analgesic	MENTHOL	DOBEST INC	722da9d1-91d7-45be-adb1-8d6a22aa83ac	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	84ea496e-ab54-4882-93ef-600f8eb33cb4	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	39564c67-49ab-42d4-a391-792ac69180c0	2023-11-11	Warnings	Exact identifier application number: M017
LIDOSOLVE PAIN RELIEF	LIDOCAINE HYDROCHLORIDE	HENNIKA HEALTH, LLC	3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2	2023-11-11	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