FDA.reportPublic FDA data

PO SUM ON MEDICATED

Product NDC
54155-052
Requested package NDC
54155-052-01
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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3APO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
MENTHOLACTIVE MOIETYL7T10EIP3APO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
CAMELLIA OILINACTIVE INGREDIENTT1PE06G0VEPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
DAEMONOROPS DRACO RESININACTIVE INGREDIENT787Z7N9UCUPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
GLYCYRRHIZA URALENSIS WHOLEINACTIVE INGREDIENT8XW1DS8UIRPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2SPO SUM ON MEDICATED (MENTHOL) OIL [PO SUM ON MEDICINE FACTORY LIMITED]2

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 54 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
application number: M017
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact 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