Freds Medicated anti itch

Product NDC
11383-265
11-digit product format
113830265
Labeler code
11383
Product ID
11383-265_8697e70b-a9a0-8c9a-e053-2991aa0a9b8e
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine hydrochloride, menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Weeks and Leo, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-13
Marketing end
0000-00-00
Substance
PRAMOXINE HYDROCHLORIDE; MENTHOL
Active strength
1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-265-01Freds Medicated anti itch1 in 1 CARTONCREAM18
11383-265-01Freds Medicated anti itch28 g in 1 TUBECREAM288
11383-265-51Freds Medicated anti itch28 g in 1 TUBECREAM285
11383-265-51Freds Medicated anti itch1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-265FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [WEEKS AND LEO, INC.]8Legacy NDC, 2 package rows20241210_8697e625-4c77-3ad6-e053-2991aa0ae50e.zip
11383-265FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [WEEKS AND LEO, INC.]5Legacy NDC, 2 package rows20190416_86986d05-8830-0853-e053-2a91aa0a4b14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN8697e625-4c77-3ad6-e053-2991aa0ae50e8
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8697e625-4c77-3ad6-e053-2991aa0ae50e8
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY8697e625-4c77-3ad6-e053-2991aa0ae50e8
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN86986d05-8830-0853-e053-2a91aa0a4b145
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD86986d05-8830-0853-e053-2a91aa0a4b145
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY86986d05-8830-0853-e053-2a91aa0a4b145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11383-265-01113830265011 in 1 CARTONHistorical
11383-265-511138302655128 g in 1 TUBE28 gHistorical