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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUSCLE	MENTHOL	WATER-JEL TECHNOLOGIES	1af399af-07b0-4899-9bcc-1e244b63b1cf	2025-04-08	Warnings	Exact identifier application number: M017
Lidocaine with Menthol	LIDOCAINE HCL AND MENTHOL	Kareway Product, Inc.	9ee46a5b-d00c-4254-e053-2995a90aeb3a	2025-04-08	Warnings	Exact identifier application number: M017
Foster and Thrive Lidocaine Pain Relief Patch	LIDOCAINE 4%	Strategic Sourcing Services LLC	324802c9-e2c2-bf74-e063-6394a90a8697	2025-04-08	Warnings	Exact identifier application number: M017
OARS AND ALPS MUSCLE RECOVERY BALM	MENTHOL, METHYL SALICYLATE	Cosco International, Inc	8745802f-018d-4cf8-bbf3-3b04c8f54538	2025-04-08	Warnings	Exact identifier application number: M017
NOVUM APR	MENTHOL	NOVUM SOLUTIONS INC	1b869a1f-5787-4d03-a546-43a8217b2b2c	2025-04-07	Warnings	Exact identifier application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLING	MENTHOL	RENU LABORATORIES, LLC	31e4fa2c-3a98-d618-e063-6394a90aec1c	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	cc7cbf4a-8274-e463-e053-2995a90a51e0	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee018a-2c3c-3116-e053-2a95a90ac8d8	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee2b65-2759-0e62-e053-2a95a90a0378	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bdc7c7f3-ac98-8fe9-e053-2a95a90a2663	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bd4fdff1-9174-31c2-e053-2a95a90a749f	2025-04-07	Warnings	Exact identifier application number: M017
GREEN GUARD Topical Pain Relief	LIDOCAINE HCI	Ultra Distributors Inc	b6f0041c-47fc-0bcd-e053-2a95a90ab1f9	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebc1c6-93fb-efd6-e053-2995a90a25bb	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 4	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0e9ac7c-a840-2e05-e053-2a95a90a33f1	2025-04-07	Warnings	Exact identifier application number: M017
CBDMEDIC Active Sport Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec5f47-2f8e-0558-e053-2a95a90aa7ca	2025-04-07	Warnings	Exact identifier application number: M017
Hot Cold Medicated Patches	HOT COLD MEDICATED PATCHES	Henan Enokon Medical Instrument Co., Ltd.	159266a8-94fa-e2ff-e063-6394a90a9a77	2025-04-02	Warnings	Exact identifier application number: M017
Pain Relief Patch	PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592d29d-e275-a44d-e063-6294a90ab17d	2025-04-02	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	766b73f2-67bd-4d5c-805c-1057b3981ebf	2025-04-02	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Asclemed USA, Inc.	d4d556c1-b64b-4b8e-8e4b-4f40eda24250	2025-04-01	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	31ce185e-07b7-d837-e063-6394a90a1fb0	2025-04-01	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