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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC04b1d605-60aa-56f4-e063-6294a90ae7602025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC0f1406fe-3a2f-bf36-e063-6294a90a7e5e2025-11-17WarningsExact identifier
application number: M017
AY BENDITO CBDMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC30a1c6b7-e37e-32c2-e063-6394a90aa3542025-11-17WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000MENTHOL, CAMPHORWorldwide Cosmetics, Inc0816cc8f-8d0b-de27-e063-6294a90a8a9d2025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLCf6538e3e-4663-679c-e053-2995a90a87b52025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLCf65455d7-04a9-6217-e053-2995a90a7c902025-11-17WarningsExact identifier
application number: M017
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact 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