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 95 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GREEN GUARD Topical Pain Relief LIDOCAINE HCI Ultra Distributors Inc b6f0041c-47fc-0bcd-e053-2a95a90ab1f9 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebc1c6-93fb-efd6-e053-2995a90a25bb 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 4 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0e9ac7c-a840-2e05-e053-2a95a90a33f1 2025-04-07 Warnings Exact identifier application number: M017 CBDMEDIC Active Sport Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec5f47-2f8e-0558-e053-2a95a90aa7ca 2025-04-07 Warnings Exact identifier application number: M017 Hot Cold Medicated Patches HOT COLD MEDICATED PATCHES Henan Enokon Medical Instrument Co., Ltd. 159266a8-94fa-e2ff-e063-6394a90a9a77 2025-04-02 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592d29d-e275-a44d-e063-6294a90ab17d 2025-04-02 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC 766b73f2-67bd-4d5c-805c-1057b3981ebf 2025-04-02 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Asclemed USA, Inc. d4d556c1-b64b-4b8e-8e4b-4f40eda24250 2025-04-01 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 31ce185e-07b7-d837-e063-6394a90a1fb0 2025-04-01 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 10.5% CVS d0ea80ce-38b2-acde-e053-2995a90a47e5 2025-03-31 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Exact identifier application number: M017 Citrus Cleansing Foot Soak and Body Soak CAMPHOR SANSAR, LLC f136616d-9f32-4e55-a495-b7466fd68526 2025-03-28 Warnings Exact identifier application number: M017 Zpol ULTRA MENTHOL, METHYL SALICYLATE Laboratorios Zepol S.A. 1a1433a6-8d04-96df-e063-6394a90a987b 2025-03-27 Warnings Exact identifier application number: M017 Muscle Recovery Foot Soak and Body Soak CAMPHOR SANSAR, LLC 1c347267-b653-41bf-9967-7feff17c38af 2025-03-27 Warnings Exact identifier application number: M017 Soothing Lavender Foot Soak and Body Soak CAMPHOR SANSAR, LLC ef26523a-b2f2-466e-89ad-f293cd64decb 2025-03-27 Warnings Exact identifier application number: M017 Achelon Lidocaine Patch LIDOCAINE PATCH 4% Achelon, Inc 31408e21-e58d-6db5-e063-6294a90aa4bc 2025-03-26 Warnings Exact identifier application number: M017 Achelon Lidocaine Patch LIDOCAINE PATCH 4% Achelon, Inc 3143bb72-2969-d66e-e063-6294a90a4604 2025-03-26 Warnings Exact identifier application number: M017 Parche Leon CAPSAICIN, CAMPHOR, MENTHOL Pharmadel LLC a8f266fa-6e43-559e-e053-2995a90a2c75 2025-03-26 Warnings Exact identifier application number: M017 Adellina Numbing Cream LIDOCAINE Guangzhou Haishi Biological Technology Co., Ltd. 314a83fe-8bdb-766f-e063-6294a90a61c6 2025-03-26 Warnings Exact identifier application number: M017 HealthWise Lidocaine Plus Menthol Patch LIDOCAINE AND MENTHOL Veridian Healthcare 312f15fe-9297-2dc2-e063-6294a90a6f4d 2025-03-25 Warnings Exact identifier application number: M017
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