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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a16c6aa-3ab0-3e46-e063-6294a90a6d8f2026-08-27WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
application number: M017
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
application number: M017
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsExact identifier
application number: M017
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsExact identifier
application number: M017
TERAPIA DE DIA Y NOCHEPAIN RELIEVING PATCHDW SUPPORT LLC59f44135-865b-9d7d-e063-6294a90a9dd92026-08-26WarningsExact 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