FDA.reportPublic FDA data

Freds Medicated anti itch

Product NDC
53943-265
11-digit product format
539430265
Labeler code
53943
Product ID
53943-265_0c530ae4-9788-7809-e063-6394a90a143d
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine hydrochloride, menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Discount Drug Mart
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-13
Substance
MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength
1; 1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Freds Medicated anti itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 g/100g
PRAMOXINE HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, 88AYB867L5
Rxcui1116155

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-265-012023-12-12C16284748780-1ba0f9c33-5871-a910-e053-dadaa90a0b85Discount Drug Mart Medicated Anti itch Cream
53943-265-012021-01-29C16284748780-1ba0f9c33-5871-a910-e053-dadaa90a0b85Discount Drug Mart Medicated Anti itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-265-01Freds Medicated anti itch1 in 1 CARTONCREAM16
53943-265-01Freds Medicated anti itch28 g in 1 TUBECREAM286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-265FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [DISCOUNT DRUG MART]6Current NDC, Legacy NDC, 2 package rows20231213_8697b932-da5a-717e-e053-2a91aa0afcae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN8697b932-da5a-717e-e053-2a91aa0afcae6
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD8697b932-da5a-717e-e053-2a91aa0afcae6
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY8697b932-da5a-717e-e053-2a91aa0afcae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-265-01539430265011 TUBE in 1 CARTON (53943-265-01) / 28 g in 1 TUBE1 tube2014-04-13NoNoHistorical