Home NDC 53943-265 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 PRAMOXINE HYDROCHLORIDE; MENTHOL
Active strength 1; 1 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53943-265-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53943-265-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53943-265-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53943-265-01 8dfbde2a14a4…c9ff85d89658…
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 Freds Medicated anti itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 g/100g MENTHOL 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116155 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53943-265-01 Freds Medicated anti itch 1 in 1 CARTON CREAM 1 6 53943-265-01 Freds Medicated anti itch 28 g in 1 TUBE CREAM 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-265 FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [DISCOUNT DRUG MART] 6 Current NDC, Legacy NDC, 2 package rows 20231213_8697b932-da5a-717e-e053-2a91aa0afcae.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53943-265-01 53943026501 1 TUBE in 1 CARTON (53943-265-01) / 28 g in 1 TUBE 1 tube 2014-04-13 No No Current