FDA.reportPublic FDA data

CVS Therapeutic Menthol Gel

Product NDC
59779-118
11-digit product format
597790118
Labeler code
59779
Product ID
59779-118_48645315-c43d-56a8-e063-6394a90ac7c5
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-01
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage59779-118-08e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage59779-118-089bebd1f3094a…5416666fcb17…

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
CVS Therapeutic Menthol Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a02605cd-40d1-4ea1-9828-0695f2d123aaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-15CVS Pharmacy ® Therapeutic Menthol Gel 8 oz
2023-01-30CVS Pharmacy ® Therapeutic Menthol Gel 8 oz
2021-12-15CVS Pharmacy ® Therapeutic Menthol Gel 8 oz
2020-01-31CVS Pharmacy ® Therapeutic Menthol Gel 8 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-118-08CVS Therapeutic Menthol Gel227 g in 1 JARGEL2277

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
MENTHOLACTIVE MOIETYL7T10EIP3ACVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ETCVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RCVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-118CVS THERAPEUTIC MENTHOL GEL (MENTHOL) GEL [CVS PHARMACY]4Current NDC, Legacy NDC, 1 package rows20241227_a02605cd-40d1-4ea1-9828-0695f2d123aa.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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSNa02605cd-40d1-4ea1-9828-0695f2d123aa7
311502menthol 0.02 MG/MG Topical GelSCDa02605cd-40d1-4ea1-9828-0695f2d123aa7
311502menthol 2 % Topical GelSYa02605cd-40d1-4ea1-9828-0695f2d123aa7
311502menthol 2 % topical stickSYa02605cd-40d1-4ea1-9828-0695f2d123aa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-118-0859779011808227 g in 1 JAR (59779-118-08) 227 g2014-10-010000-00-00NoNoCurrent