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 59 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc	7d4e21d1-2914-4690-9084-a52abeab0958	2025-12-02	Warnings	Exact identifier application number: M017
Rugby Capsaicin Cream	CAPSAICIN	Rugby Laboratories	9eca34f1-e91a-3ac1-e053-2a95a90a9bd9	2025-12-02	Warnings	Exact identifier application number: M017
Leader Capsaicin Pain Relief Cream	CAPSAICIN	Cardinal Health 110 dba LEADER	a5620709-0fed-4979-e053-2a95a90ac654	2025-12-02	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)	HYDROCORTISONE ACETATE	Sun Pharmaceutical Industries, Inc.	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	2025-12-02	Warnings	Exact identifier application number: M017
POMG NIGHT TIME PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE	POMG LLC	28d7dfb0-a94c-90de-e063-6294a90a036a	2025-12-02	Warnings	Exact identifier application number: M017
Thermacare Max Strength Lidocaine	THERMACARE MAX STRENGTH LIDOCAINE	Clarion Brands LLC	44fed887-d1e0-d205-e063-6294a90ac416	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ON	MENTHOL	SUNSET NOVELTIES, INC	45037bc1-aa03-11ae-e063-6294a90a6c96	2025-12-02	Warnings	Exact identifier application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ON	CAMPHOR	SUNSET NOVELTIES, INC	45048936-f3c9-25f7-e063-6394a90ac4a9	2025-12-02	Warnings	Exact identifier application number: M017
CAREALL Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM	New World Imports, Inc	3a01f57a-ebc6-4724-b625-1d1ea4b85e73	2025-12-01	Warnings	Exact identifier application number: M017
CareALL Arthritis and Muscle	CAPSAICIN	New World Imports, Inc	4867eac4-00ea-434e-b289-1c1ef0342c23	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	e2df8130-e7c8-4fde-a6d6-c71378991213	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	d04e473d-8bbc-475c-a0b1-ca5eed67fbc7	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	cba7c084-379f-4a16-aeba-b11ca6e20d8a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Muscle Rub Ultra Strength	MENTHOL, METHYL SALICYLATE	New World Imports, Inc	d066002d-8ceb-4d16-9744-d5ca25d2ad5a	2025-12-01	Warnings	Exact identifier application number: M017
CAREALL Musle and Joint	MENTHOL	New World Imports, Inc	013beea4-b2c2-4e84-b4cb-3125ac48e8c0	2025-12-01	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	A2A Integrated Pharmaceuticals, LLC	147f3594-7362-7a78-e063-6294a90a3e42	2025-11-30	Warnings	Exact identifier application number: M017
Aquanil HC	HYDROCORTISONE	Person and Covey	6b9258e4-c7c4-765e-e053-2991aa0a9f4e	2025-11-29	Warnings	Exact identifier application number: M017
Walgreen Pain Relieving Fragrance Free	LIDOCAINE HYDROCHLORIDE	WALGREENS CO.	62c50ded-3fc9-4f65-9bfb-1144ed2e36b4	2025-11-26	Warnings	Exact identifier application number: M017
Itch Relief	ITCH RELIEF GEL	Neilmed Pharmaceuticals Inc.	44811828-c32e-17fc-e063-6294a90add48	2025-11-26	Warnings	Exact identifier application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon	THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON	Clarion Brands LLC	4482d34d-eaca-5522-e063-6394a90a6afb	2025-11-26	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