PERFORM COOL and SOOTHING PAIN RELIEVING

Product NDC
59316-111
11-digit product format
593160111
Labeler code
59316
Product ID
59316-111_51e0a9b2-bf58-7444-e063-6394a90a3e3a
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Reckitt Benckiser LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-18
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
35 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PERFORM COOL and SOOTHING PAIN RELIEVING
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM35 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui808955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-111-10PERFORM COOL and SOOTHING PAIN RELIEVING3 mL in 1 TUBEGEL39
59316-111-11PERFORM COOL and SOOTHING PAIN RELIEVING30 mL in 1 BOTTLEGEL309
59316-111-20PERFORM COOL and SOOTHING PAIN RELIEVING1 in 1 CARTONGEL19
59316-111-20PERFORM COOL and SOOTHING PAIN RELIEVING118 mL in 1 TUBEGEL1189

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3APERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
MENTHOLACTIVE MOIETYL7T10EIP3APERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
HYPERICUM OILINACTIVE INGREDIENTOZU2FC70HYPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
LAVANDIN OILINACTIVE INGREDIENT9RES347CKGPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
LIME OILINACTIVE INGREDIENTUZH29XGA8GPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
NUTMEG OILINACTIVE INGREDIENTZ1CLM48948PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740YPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
THYME OILINACTIVE INGREDIENT2UK410MY6BPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59316-111PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [RB HEALTH (US) LLC]8Current NDC, Legacy NDC, 4 package rows20241228_ef158f63-2d75-47a3-b94a-2d821d511863.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSNef158f63-2d75-47a3-b94a-2d821d5118639
808955menthol 0.035 MG/MG Topical GelSCDef158f63-2d75-47a3-b94a-2d821d5118639
808955menthol 3.5 % Topical GelSYef158f63-2d75-47a3-b94a-2d821d5118639

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59316-111-10593160111103 mL in 1 TUBE (59316-111-10) 3 ml2015-05-182023-12-31NoNoCurrent
59316-111-115931601111130 mL in 1 BOTTLE (59316-111-11) 30 ml2015-05-182023-12-31NoNoCurrent
59316-111-20593160111201 TUBE in 1 CARTON (59316-111-20) / 118 mL in 1 TUBE1 tube2015-05-180000-00-00NoNoCurrent