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 99 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone with aloe	HYDROCORTISONE	Encube Ethicals, Inc.	12a1774d-a97e-4787-b6b1-8e8cd40b7b70	2025-02-26	Warnings	Exact identifier application number: M017
Thera Plus Maximum Strength Feminine Anti-Itch	BENZOCAINE, RESORCINOL	FOURSTAR GROUP USA, INC.	0007e3ea-882b-4000-8e70-2bcec2c08613	2025-02-26	Warnings	Exact identifier application number: M017
Tattoo numbing cream	LIDOCAINE	BLOOMWELL GARDENS LLC	2ea9d34e-408d-f8d6-e063-6394a90a72a4	2025-02-26	Warnings	Exact identifier application number: M017
Icy Hot Pro No-Mess	CAMPHOR, MENTHOL	Chattem, Inc.	9e8fedf5-fb59-4531-b288-715f851ee05b	2025-02-26	Warnings	Exact identifier application number: M017
Family Wellness Max Strength 1 Hydrocortisone Cream	HYDROCORTISONE	Family Dollar Stores, Inc	bca5ac2c-45cd-44e3-98f1-317a04e44d7d	2025-02-25	Warnings	Exact identifier application number: M017
Tylenol Precise Nighttime Pain Relieving	CAMPHOR, MENTHOL	Kenvue Brands LLC	2ef4fe16-0820-6aad-e063-6294a90a8449	2025-02-25	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Preferred Pharmaceuticals Inc.	c259ef92-5d07-4590-adf1-3a106333eee0	2025-02-21	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll On	MENTHOL	ADP Health Limited	420d8cdc-f47f-4d33-bf25-9033ff266c49	2025-02-19	Warnings	Exact identifier application number: M017
AVCOO Pain Relief	MENTHOL	ADP Health Limited	700ce2cf-749e-40be-91c3-850d9b2168ca	2025-02-19	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	Jell Pharmaceuticals Pvt. Ltd	2e7c49de-5438-4858-e063-6294a90ad98c	2025-02-19	Warnings	Exact identifier application number: M017
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	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