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 81 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE	HYDROCORTISONE	Click Industries LLC	328c389c-7e05-4892-a9b3-b6a753f4935a	2025-08-25	Warnings	Exact identifier application number: M017
Yeheal	CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL	Shenzhen Yeheal Biotechnology Co., Ltd	3cf1bc74-3060-6d63-e063-6294a90a9f5c	2025-08-22	Warnings	Exact identifier application number: M017
Dermedial Anti-Ouch	MENTHOL	Natures Formulae Health Products Ltd.	3ce29160-3964-e435-e063-6394a90abb38	2025-08-21	Warnings	Exact identifier application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVE	MENTHOL	RENU LABORATORIES, LLC	fa2f9539-b703-a00b-e053-6394a90ae309	2025-08-21	Warnings	Exact identifier application number: M017
Camphor 4% Plus Menthol 10%	CAMPHOR 4% PLUS MENTHOL 10%	PureTek Corporation	3cab26e4-e377-f26a-e063-6394a90a17af	2025-08-20	Warnings	Exact identifier application number: M017
Capsaicin 0.035% Cream	CAPSAICIN 0.035% CREAM	Puretekcorp	3cbc73b6-8c58-8f23-e063-6394a90a71a3	2025-08-20	Warnings	Exact identifier application number: M017
Game On	MENTHOL, METHYL SALICYLATE	Natural Essentials, Inc.	3cd20f1f-033f-f698-e063-6294a90a89eb	2025-08-20	Warnings	Exact identifier application number: M017
ELAIMEI Numbing Cream	LIDOCAINE 4%	Shenzhen Shandian Jingling Technology Co., Ltd.	37ac13b2-ca55-0e28-e063-6294a90a000e	2025-08-19	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	FSA Store Inc.	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	2025-08-19	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE SPRAY	FSA Store Inc.	3ce24b87-55ac-0bbd-e063-6294a90ab582	2025-08-19	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	15a26af1-ca5a-40fc-a411-6c0e8ae18fbb	2025-08-18	Warnings	Exact identifier application number: M017
Orythia Maximum Strength Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	6d6b59f9-f614-4e3c-b07b-32b4591d39f2	2025-08-18	Warnings	Exact identifier application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving Soothing	LIDOCAINE	GNL BRANDS INTERNATIONAL, LLC	3c69654c-cba6-dfef-e063-6394a90ad479	2025-08-15	Warnings	Exact identifier application number: M017
Earth Mama Medicated Herbal Lip Balm	MENTHOL	Eleeo Brands LLC	3c6c16bb-1f4b-b851-e063-6294a90a7404	2025-08-15	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Cintas First Aid & Safety	96f17095-31f3-4b8a-ab22-0caaefaa7476	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Cold Ice Analgesic Gel	MENTHOL	SHIELD LINE LLC	860a2c86-b240-4e0e-e053-2a91aa0a333a	2025-08-15	Warnings	Exact identifier application number: M017
MedPride Medicated Body Powder Powder	MENTHOL, ZINC OXIDE	Shield Line LLC	cdb2fa5b-cf04-c876-e053-2a95a90a187c	2025-08-15	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	c5ff392a-e788-43e0-91ea-5e0f8420586c	2025-08-15	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	40df30ba-41ba-42b7-93fe-4183b57bdb00	2025-08-14	Warnings	Exact identifier application number: M017
Signature Care Aloe Vera Gel with Lidocaine	LIDOCAINE	Safeway, Inc.	d5069622-97b1-ba12-e053-2a95a90a7268	2025-08-14	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