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
IngredientStrength
MENTHOL15 g/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54155-052-01PO SUM ON MEDICATED30 mL in 1 BOTTLE, GLASSOIL306
54155-052-01PO SUM ON MEDICATED1 in 1 CANOIL16
54155-052-02PO SUM ON MEDICATED5.6 mL in 1 BOTTLE, GLASSOIL5.66
54155-052-02PO SUM ON MEDICATED1 in 1 BOXOIL16

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54155-052PO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]5Current NDC, Legacy NDC, 4 package rows20241127_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 6 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-proprietary nameHEADACHE PATCHNanjing 3H Medical Products Co.,Ltd.586d73f1-0b0b-f596-e063-6394a90a4d572026-08-06WarningsExact identifier
application number: M017
Point Relief Coldspot Pain RelievingMENTHOLFabrication Enterprises Inc479fb728-4aeb-42e3-b238-f04255514baa2026-08-05WarningsExact identifier
application number: M017
Dealmed BurnLIDOCAINEDealmed Medical Supplies, LLC.3b5f7ded-c275-4d7f-9fd4-539797d5507e2026-08-05WarningsExact identifier
application number: M017
Lidocaine HClLIDOCAINE HCLTopco Associates LLC584e1f35-4d99-9c85-e063-6294a90ab3d02026-08-05Warnings, Adverse reactionsExact identifier
application number: M017
Hempe HOT Muscle and Joint GelHEMPEHealthcare International Research Limited5854a80e-c92b-3ff5-e063-6294a90a2d052026-08-05WarningsExact identifier
application number: M017
Lidocaine Plantar Relief Roll-OnLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.585ccb4b-3bff-39b9-e063-6294a90a0e182026-08-05WarningsExact identifier
application number: M017
Green MARVEL PAIN RELIEFMENTHOL, CAMPHOR, METHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Lab9ff6e477-ef79-4a0c-9e21-8cae0e5d88102026-08-05WarningsExact identifier
application number: M017
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.56e36592-a935-61d4-e063-6294a90a6e4c2026-08-04WarningsExact identifier
application number: M017
Mineral Ice Extreme Menthol Pain ReliefMENTHOLCarlin Consumer Health LLC584f5c6e-3385-3221-e063-6294a90aabae2026-08-04WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack484fe5e4-a058-49c0-a382-c8fc3e20c3b22026-08-04WarningsExact identifier
application number: M017
procureHYDROCORTISONE ACETATETWIN MED, LLC2670c9c4-66ad-40e8-a08a-582b160de39d2026-08-03WarningsExact identifier
application number: M017
Wini By Locsanity Advanced Formula Muscle Joint Relief BalmMETHYL SALICYLATE,CAMPHOR,MENTHOLLocsanity LLC5829b5d7-78d4-78a2-e063-6394a90a3dfc2026-08-03WarningsExact identifier
application number: M017
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll OnMENTHOLChattem, Inc.aa40c907-eeb5-4fda-b35e-439cbecc178c2026-07-31WarningsExact identifier
application number: M017
Alphamale Delay CreamBENZOCAINEProdigy Media Inc53d682ee-0802-a16d-e063-6394a90aeee12026-07-31WarningsExact identifier
application number: M017
Pure Primal Delay CreamBENZOCAINEProdigy Media Inc57e9e894-c14f-d806-e063-6394a90ab8e52026-07-31WarningsExact identifier
application number: M017
SatohapDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.df0e2b83-8f61-4ed8-bcc4-55e4ea7820902026-07-31WarningsExact identifier
application number: M017
SatogesicDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.cb000134-92a4-4304-8ef0-0347190e14142026-07-31WarningsExact identifier
application number: M017
Satogesic HotCAPSAICINSato Pharmaceutical Co., Ltd.16b47cb5-ea5f-4514-9a89-141ee4cc60f82026-07-31WarningsExact identifier
application number: M017
Satohap Cool and Hot PadsCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceutical Co., Ltd.b6bf1eab-4ab9-f500-e053-2995a90a8d7b2026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
SATOHAP COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54155-052-01541550052011 BOTTLE, GLASS in 1 CAN (54155-052-01) / 30 mL in 1 BOTTLE, GLASS2026-08-272030-09-02NoNoCurrent
54155-052-02541550052021 BOTTLE, GLASS in 1 BOX (54155-052-02) / 5.6 mL in 1 BOTTLE, GLASS2026-08-272030-09-02NoNoCurrent