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 119 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE	Kroger Company	fc1677f2-4078-4ebd-9c3b-86a29a35b489	2024-11-12	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Cream	LIDOCAINE	CVS Health	ad950680-c03c-4fa5-aa7f-239a889cd097	2024-11-12	Warnings	Exact identifier application number: M017
CVS Arthritis Pain Relief	ARTHRITIS PAIN RELIEF	CVS Health	575dd514-fd99-4e44-8fc8-52938f9abc26	2024-11-11	Warnings	Exact identifier application number: M017
ThermaPatch (TM) Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	26769590-cd50-1b01-e063-6394a90a445c	2024-11-09	Warnings	Exact identifier application number: M017
DG Health Cold Zone Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Dolgencorp Inc	22594ab8-9a4a-426f-aced-5c636620fa2c	2024-11-08	Warnings	Exact identifier application number: M017
Peviderm Pramoxine Hydrocholride 1%	PRAMOXINE HYDROCHLORIDE	Stratus Pharmaceuticals Inc	680b40fa-1922-443a-a4b0-7c3f6a2b847d	2024-11-07	Warnings	Exact identifier application number: M017
Meijer Analgesic with Aloe Topical Analgesic	TROLAMINE SALICYLATE	Meijer Distribution, Inc	f6c1e09e-4c61-4c2a-87d7-b052ed36fcac	2024-11-07	Warnings	Exact identifier application number: M017
Meijer Pain Relieving Balm Analgesic	TROLAMINE SALICYLATE	Meijer Distribution, Inc	1b7535cc-01ac-49f0-9889-dd14b254d4ae	2024-11-07	Warnings	Exact identifier application number: M017
BENGAY Tropical Jasmine	LIDOCAINE	Kenvue Brands LLC	c416320a-c0d7-401e-b0fa-44114d76a557	2024-11-06	Warnings	Exact identifier application number: M017
Bengay Ultra Strength Large Size	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	f57ccc33-400b-4401-a348-c54d1eb9f5d0	2024-11-06	Warnings	Exact identifier application number: M017
Band Aid Antiseptic Cleansing To Go	BENZALKONIUM CHLORIDE, PRAMOXINE HCL	Kenvue Brands LLC	d5749cba-32f3-cf9c-e053-2a95a90a4416	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	26473383-282c-fb10-e063-6394a90a5fa2	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	1b6f929a-db65-8a02-e063-6394a90a8b59	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	bd6f04f9-a23b-45f6-bce2-1ef7203198e1	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	6d356563-9098-4994-8ad8-819a8033a9f4	2024-11-06	Warnings	Exact identifier application number: M017
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	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