FDA.reportPublic FDA data

MEDICATED ANTI-ITCH

Product NDC
0363-3231
11-digit product format
003633231
Labeler code
0363
Product ID
0363-3231_b917119c-dd16-4bdc-ae23-4f6e8efe5275
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 1 % Pramoxine Hydrochloride 1 %
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreens
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-15
Marketing end
0000-00-00
Substance
MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength
1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3231-022020-01-31C16284748780-19d75b9d0-3c31-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3231-02MEDICATED ANTI-ITCHWell at Walgreens56 g in 1 TUBECREAM562
0363-3231-02MEDICATED ANTI-ITCHWell at Walgreens1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3AMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Pramoxine HydrochlorideACTIVE INGREDIENT88AYB867L5MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
MENTHOLACTIVE MOIETYL7T10EIP3AMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
PRAMOXINEACTIVE MOIETY068X84E056MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
ACRYLAMIDEINACTIVE INGREDIENT20R035KLCIMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
EucalyptolINACTIVE INGREDIENTRV6J6604TKMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Iodopropynyl ButylcarbamateINACTIVE INGREDIENT603P14DHEBMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
PPG-1 Trideceth-6INACTIVE INGREDIENT1K7417JX6QMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Steareth-2INACTIVE INGREDIENTV56DFE46J5MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Steareth-21INACTIVE INGREDIENT53J3F32P58MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
ThymolINACTIVE INGREDIENT3J50XA376EMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1
WaterINACTIVE INGREDIENT059QF0KO0RMEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3231MEDICATED ANTI-ITCH WELL AT WALGREENS (MENTHOL 1 % PRAMOXINE HYDROCHLORIDE 1 %) CREAM [WALGREENS]2Legacy NDC, 2 package rows20180216_32275ee3-7afd-4272-a47b-bb26bc045f72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN32275ee3-7afd-4272-a47b-bb26bc045f722
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD32275ee3-7afd-4272-a47b-bb26bc045f722
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY32275ee3-7afd-4272-a47b-bb26bc045f722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0363-3231-020036332310256 g in 1 TUBE56 gHistorical