Flexigen

Product NDC
72839-371
11-digit product format
728390371
Labeler code
72839
Product ID
72839-371_0f0164f7-b392-1bfd-e063-6394a90a3ca0
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 1.25%
Dosage form
CREAM
Route
TOPICAL
Labeler
Derma Care Research Labs, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-11
Substance
MENTHOL
Active strength
1.25 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Flexigen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.25 g/100mL

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
416982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9ae2682-59b4-e796-e053-2995a90af921Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-371-01Flexigen5 mL in 1 BOTTLECREAM52
72839-371-03Flexigen95 mL in 1 BOTTLECREAM952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-371FLEXIGEN (MENTHOL 1.25%) CREAM [DERMA CARE RESEARCH LABS, LLC]2Current NDC, Legacy NDC, 2 package rows20240116_e9ae2682-59b4-e796-e053-2995a90af921.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 45 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare6834a6de-4d1d-4e40-945d-ec5c267abd142026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSNe9ae2682-59b4-e796-e053-2995a90af9212
416982menthol 12.5 MG/ML Topical CreamSCDe9ae2682-59b4-e796-e053-2995a90af9212
416982menthol 1.25 % Topical CreamSYe9ae2682-59b4-e796-e053-2995a90af9212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72839-371-01728390371015 mL in 1 BOTTLE (72839-371-01) 5 ml2022-07-11NoNoCurrent
72839-371-037283903710395 mL in 1 BOTTLE (72839-371-03) 95 ml2022-07-110000-00-00NoNoCurrent