FDA.reportPublic FDA data

MG PLUS ROLL ON

Product NDC
76348-971
11-digit product format
763480971
Labeler code
76348
Product ID
76348-971_535dc42f-38c8-2afc-e063-6294a90ae23d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Roll On
Dosage form
LIQUID
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-08
Substance
MENTHOL
Active strength
4.2 g/84g
NDC exclude flag
No
Listing certified through
2027-12-31
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
MG PLUS ROLL ON
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.2 g/84g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
535dc42f-38c7-2afc-e063-6294a90ae23dAvailable on FDA.report

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 47 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.4a24e813-6dbc-3fd1-e063-6294a90a4ff02026-01-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLVillage Pharma LLCd0ec7d25-ad58-46f2-b3b3-f13b4648b0b62026-01-01WarningsExact identifier
application number: M017
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLFSA Store Inc.47434af6-0fdd-9615-e063-6394a90ab9e82025-12-31WarningsExact identifier
application number: M017
Winco Lidocaine Pain Patch 4% 5ctLIDOCAINE PAIN PATCH 4%WINCO FOODS, LLC47439162-fc34-f0d0-e063-6394a90a29ab2025-12-31WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHQUEST USA CORP.1ad47834-4f8e-c692-e063-6294a90a7e772025-12-31WarningsExact identifier
application number: M017
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
application number: M017
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub LavenderCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company47473b24-a3e3-2858-e063-6394a90a59202025-12-31WarningsExact identifier
application number: M017
Eucerin Itch Relief Intensive CalmingMENTHOLBeiersdorf Inca7a78af1-1f5a-684d-e053-2a95a90a6ae92025-12-31WarningsExact identifier
application number: M017
Eucerin Skin Calming Itch Relief TreatmentMENTHOLBeiersdorf Inc7e568311-1e6b-9b4b-e053-2991aa0a7b672025-12-31WarningsExact identifier
application number: M017
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsExact identifier
application number: M017
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
application number: M017
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsExact identifier
application number: M017
Kroger Hot and Cold Medicated PatchMENTHOLKroger Company0331c1dd-fe30-421a-85a7-6c6886e7ab272025-12-30WarningsExact identifier
application number: M017
Menthol, CamphorMENTHOL, CAMPHORChemco Corporation472fb097-92e5-c230-e063-6294a90ab33a2025-12-30WarningsExact identifier
application number: M017
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-971-037634809710384 g in 1 BOTTLE, WITH APPLICATOR (76348-971-03) 84 g2026-06-08NoNoCurrent