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 60 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sohm Pain Away	MENTHOL, CAMPHOR	SOHM, Inc	86632acf-80ae-48d7-a0bb-7ec980326bae	2025-11-25	Warnings	Exact identifier application number: M017
HealthWise Lidocaine Pain Relief	LIDOCAINE 4%	Veridian Healthcare	6f2332c0-e078-40a8-9564-f47d21bc491b	2025-11-25	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON WARMING	CAMPHOR	Just Brands LLC	44779065-5f57-8f01-e063-6394a90a3f8e	2025-11-25	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON COOLING	MENTHOL	Just Brands LLC	44786cb6-176e-cc6e-e063-6394a90a54ad	2025-11-25	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	VALU MERCHANDISERS, CO	3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff	2025-11-24	Warnings	Exact identifier application number: M017
Menthol	MAXIMUM STRENGTH MEDICATED FOOT POWDER	VALU MERCHANDISERS, CO	89a5c4bb-442f-d3f0-e053-2a95a90a51bd	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d113dec-8832-d984-e063-6394a90ae7b3	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d12f03f-dd8b-0be5-e063-6294a90a43db	2025-11-24	Warnings	Exact identifier application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel	THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL	Clarion Brands LLC	445db02a-c8e8-6ebb-e063-6294a90a4301	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d129641-eaea-c3ee-e063-6394a90aa58f	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d1059cc-1b0b-4e7b-e063-6294a90a56ea	2025-11-24	Warnings	Exact identifier application number: M017
GuruNanda Pain Relief	MENTHOL AND CAMPHOR	GURUNANDA, LLC	3ca78342-cc6d-5f6b-e063-6294a90a3f1c	2025-11-24	Warnings	Exact identifier application number: M017
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d118256-90ee-28ef-e063-6394a90a21e8	2025-11-24	Warnings	Exact identifier application number: M017
health beyond	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af	2025-11-23	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches 3 Step	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	4429fea8-46f8-8f7f-e063-6394a90a34b4	2025-11-22	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches 2 Step	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	442a926b-d7c1-4e35-e063-6394a90ad948	2025-11-22	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches 1 Step	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	442aae32-4ac6-5dd6-e063-6294a90aad02	2025-11-22	Warnings	Exact identifier application number: M017
NicDuic Quit Smoking Nicotine Patches 1-3 Step	21MG NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	442ae0fa-a1ed-7901-e063-6294a90ab717	2025-11-22	Warnings	Exact identifier application number: M017
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Dextrum Laboratories, Inc	441daa6f-f273-ac09-e063-6394a90a252c	2025-11-21	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