FDA.reportPublic FDA data

Family Care Maximum Strength Medicated Anti Itch

Product NDC
65923-104
11-digit product format
659230104
Labeler code
65923
Product ID
65923-104_41b455e2-0768-80cb-e063-6394a90a5698
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-24
Substance
MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength
10; 10 mg/g; mg/g
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
Family Care Maximum Strength Medicated Anti Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
430b5753-3087-4cb1-bf54-0eedc3f4b1d5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-104-14Family Care Maximum Strength Medicated Anti Itch1 in 1 CARTONCREAM116
65923-104-14Family Care Maximum Strength Medicated Anti Itch14 g in 1 TUBECREAM1416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
MENTHOLACTIVE MOIETYL7T10EIP3AFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
PRAMOXINEACTIVE MOIETY068X84E056FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-104FAMILY CARE MAXIMUM STRENGTH MEDICATED ANTI ITCH (MENTHOL) CREAM [UNITED EXCHANGE CORP.]14Current NDC, Legacy NDC, 2 package rows20250305_430b5753-3087-4cb1-bf54-0eedc3f4b1d5.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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN430b5753-3087-4cb1-bf54-0eedc3f4b1d516
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD430b5753-3087-4cb1-bf54-0eedc3f4b1d516
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY430b5753-3087-4cb1-bf54-0eedc3f4b1d516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-104-14659230104141 TUBE in 1 CARTON (65923-104-14) / 14 g in 1 TUBE1 tube2018-10-300000-00-00NoNoCurrent