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 120 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEAcme United Corporationf1f051ad-7e82-9d1a-e053-2a95a90ac7d32024-11-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEALLIED TRADE LINK LLC26bc238d-3bda-0c29-e063-6394a90a35fb2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAcme United Corporationfabcaa3b-d189-bd29-e053-6294a90ae86b2024-11-12WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP8414aea2-52b5-4221-e053-2a91aa0a622e2024-11-12WarningsExact identifier
application number: M017
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.26c7116f-c86d-8752-e063-6294a90ab73f2024-11-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEKroger Companyfc1677f2-4078-4ebd-9c3b-86a29a35b4892024-11-12WarningsExact identifier
application number: M017
CVS Health Lidocaine CreamLIDOCAINECVS Healthad950680-c03c-4fa5-aa7f-239a889cd0972024-11-12WarningsExact identifier
application number: M017
CVS Arthritis Pain ReliefARTHRITIS PAIN RELIEFCVS Health575dd514-fd99-4e44-8fc8-52938f9abc262024-11-11WarningsExact identifier
application number: M017
ThermaPatch (TM) Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.26769590-cd50-1b01-e063-6394a90a445c2024-11-09WarningsExact identifier
application number: M017
DG Health Cold Zone Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc22594ab8-9a4a-426f-aced-5c636620fa2c2024-11-08WarningsExact identifier
application number: M017
Peviderm Pramoxine Hydrocholride 1%PRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals Inc680b40fa-1922-443a-a4b0-7c3f6a2b847d2024-11-07WarningsExact identifier
application number: M017
Meijer Analgesic with Aloe Topical AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Incf6c1e09e-4c61-4c2a-87d7-b052ed36fcac2024-11-07WarningsExact identifier
application number: M017
Meijer Pain Relieving Balm AnalgesicTROLAMINE SALICYLATEMeijer Distribution, Inc1b7535cc-01ac-49f0-9889-dd14b254d4ae2024-11-07WarningsExact identifier
application number: M017
BENGAY Tropical JasmineLIDOCAINEKenvue Brands LLCc416320a-c0d7-401e-b0fa-44114d76a5572024-11-06WarningsExact identifier
application number: M017
Bengay Ultra Strength Large SizeMENTHOL, UNSPECIFIED FORMKenvue Brands LLCf57ccc33-400b-4401-a348-c54d1eb9f5d02024-11-06WarningsExact identifier
application number: M017
Band Aid Antiseptic Cleansing To GoBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd5749cba-32f3-cf9c-e053-2a95a90a44162024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.26473383-282c-fb10-e063-6394a90a5fa22024-11-06WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLGOLDEN TIGER DISTRIBUTION L.L.C.1b6f929a-db65-8a02-e063-6394a90a8b592024-11-06WarningsExact identifier
application number: M017
Meijer Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incbd6f04f9-a23b-45f6-bce2-1ef7203198e12024-11-06WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc6d356563-9098-4994-8ad8-819a8033a9f42024-11-06WarningsExact 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