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 88 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plantar Fasciitis Cream	CAMPHOR	SOLALIA LLC	388f33c2-2bdf-ded8-e063-6294a90aeeac	2025-06-27	Warnings	Exact identifier application number: M017
4 Lidocaine Topical Anesthetic	LIDOCAINE	RUGBY LABORATORIES	63327e57-f4c8-4ae6-9d28-cef8697bbdcc	2025-06-27	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	ANTI-ITCH CONTINUOUS SPRAY	Wal-Mart Stores, Inc.	709c3bb8-5b36-4823-941a-45ddb3e431c4	2025-06-27	Warnings	Exact identifier application number: M017
Burn Relief Professional Bio-Kool	LIDOCAINE - 4%	Kool-Down Inc.	827e9c69-4706-0ccf-e053-2991aa0aa1c1	2025-06-27	Warnings	Exact identifier application number: M017
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3875bde5-2e1a-5fdf-e063-6294a90a3c0d	2025-06-26	Warnings	Exact identifier application number: M017
SupreH Bee Venom Arthritis Pain Relieving Cream	SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3876cc44-7f3a-b084-e063-6294a90a6142	2025-06-26	Warnings	Exact identifier application number: M017
MediBalm	HYDROCORTISONE	BalmRx, LLC	324dd151-84c5-3e2f-e063-6394a90a569d	2025-06-26	Warnings	Exact identifier application number: M017
PHIZICO Pain Relief	MENTHOL	ER3 BRANDS INC.	72715dc5-d1e7-4b4b-8e28-4e367abba322	2025-06-25	Warnings	Exact identifier application number: M017
Diva Cramp Care Cream	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	37368566-b14e-4d5c-bdde-6eea9073974f	2025-06-25	Warnings	Exact identifier application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH	LIDOCAINE HCL	H2Ocean, LLC	386bf11b-1d71-44bf-e063-6394a90a2817	2025-06-25	Warnings	Exact identifier application number: M017
Burn Relief Extra Strength Kool-Down	LIDOCAINE - 3.9%	Kool-Down Inc	827fec2f-db3c-adbb-e053-2a91aa0a7c17	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Blue Gel Anesthetic	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9db681-a297-5aa9-e063-6394a90a80ea	2025-06-25	Warnings	Exact identifier application number: M017
Hilook Numbing Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	1b9f1a4c-ca0b-d820-e063-6394a90a3239	2025-06-25	Warnings	Exact identifier application number: M017
Lidocaine Knee Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	384c1ff8-80bd-86cb-e063-6394a90a2d65	2025-06-24	Warnings	Exact identifier application number: M017
Aroamas Cot Nicotine Transdermal Patches Kit	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	38576022-9413-c9af-e063-6294a90afd46	2025-06-24	Warnings	Exact identifier application number: M017
NERVE REVERSE PAIN RELIEF	MENTHOL	Pogue Medical Services	da97bcc6-5aa8-48e2-a2c2-c937745bf6d3	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief Menthol Roll-On	MENTHOL	Respect Manufacturing Corporation	05a6067a-287a-52d4-e063-6394a90a2c4e	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 500mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06c4640a-ee42-5d1a-e063-6394a90ad254	2025-06-23	Warnings	Exact identifier application number: M017
Medterra Pain Relief 1000mg Hemp Menthol Cream	MENTHOL	Respect Manufacturing Corporation	06e944e8-71f6-9fe9-e063-6294a90a8c37	2025-06-23	Warnings	Exact identifier application number: M017
Procure gel	MENTHOL	TWIN MED, LLC	e69c0b68-d408-9fd2-e053-2a95a90ac934	2025-06-20	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