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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsMETHYL SALICYLATE 10% GEL PATCHDr. Sabharwal's Wound Care4a7790bb-25cb-72b8-e063-6294a90a6b9c2026-06-29WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
application number: M017
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
application number: M017
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
application number: M017
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
application number: M017
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas, LLC5517ee5f-1c51-cfd6-e063-6294a90af56f2026-06-25WarningsExact identifier
application number: M017
Marie Originals Medicated Outdoor Anti ItchHYDROCORTISONE SPRAYMarie's Original Formulas LLC55188ede-68cd-fcc6-e063-6394a90a5c582026-06-25WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%NuCare Pharmaceuticals, Inc.54f07a23-213f-ca46-e063-6394a90a00342026-06-24WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONMENTHOL,PRAMOXINE HYDROCHLORIDERida LLCb62d09e4-7ced-49a9-8c83-3a8ef580f25a2026-06-23WarningsExact identifier
application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATIONPRAMOXINE HYDROCHLORIDERida LLC5b2cb1bd-2f1e-4670-b40e-6c058bfd12a22026-06-23WarningsExact identifier
application number: M017
Pain Relieving cleansing sparyBENZALKONIUM CHLORIDE AND LIDOCAINE HCITrifecta Pharmaceuticals USA, LLC.48edbb8d-0c35-91d8-e063-6394a90a71b82026-06-19WarningsExact identifier
application number: M017
Pain ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
application number: M017
Tiger Balm Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.011fc383-10bc-44cf-a67c-4be45fef33e02026-06-19WarningsExact identifier
application number: M017
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
application number: M017
Careland Kinesiology Dual Action Pain Relieving TapeLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.67e0b3c5-e88e-4c48-a1e8-39f502ac249d2026-06-18WarningsExact identifier
application number: M017
ZensaLIDOCAINEAlera Skin Care Products Inc.549348ec-2eb2-3781-e063-6294a90a2f4a2026-06-18WarningsExact identifier
application number: M017
SprayPain AwayCAPSAICINProximity Capital Partners LLC dba Asutrac603e999-2316-496a-e053-2995a90ab4ed2026-06-17WarningsExact identifier
application number: M017
SprayPain Away LavenderCAPSAICINProximity Capital Partners LLC dba Asutra547e2167-ade0-ac7e-e063-6294a90a18ea2026-06-17WarningsExact 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