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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact 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