Home NDC 54859-202 Dermagesic
Product NDC 54859-202
11-digit product format 548590202
Labeler code 54859
Product ID 54859-202_47467902-6ca7-2b20-e063-6394a90aeff1
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine HCl, Zinc Oxide, Calamine
Dosage form CREAM
Route TOPICAL
Labeler Llorens Pharmaceutical International Division
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-01
Substance PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED
Active strength 10; 4; 4 mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 4 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54859-202-04 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54859-202-04 9bebd1f3094a…5416666fcb17…
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 Dermagesic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/g ZINC OXIDE 4 mg/g FERRIC OXIDE RED 4 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup SOI2LOH54Z Internal UNII lookup 1K09F3G675 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1798481 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 54859-202-04 Dermagesic 113 g in 1 JAR CREAM 113 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-202 DERMAGESIC (PRAMOXINE HCL, ZINC OXIDE, CALAMINE) CREAM [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] 6 Current NDC, Legacy NDC, 1 package rows 20241222_bbff6b53-29da-45c1-8ccd-3e9df7f250e0.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 37 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAIN RELIEF PATCHES LIDOCAINE WALMART STORES INC b82cfe42-f521-4784-8c60-98481524c5ec 2026-01-29 Warnings Exact identifier application number: M017 Equate Pain Relief Patch Camphor/Menthol/Salicylate CAMPHOR, MENTHOL, METHYL SALICYLATE Walmart Stores Inc b869848c-21e2-5ca2-e053-2995a90a86f2 2026-01-29 Warnings Exact identifier application number: M017 HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL SUNSET NOVELTIES, INC 498cd2aa-ee59-67b5-e063-6294a90ac242 2026-01-29 Warnings Exact identifier application number: M017 COOLING PAIN RELIEF MENTHOL, CAMPHOR SUNSET NOVELTIES, INC 498d76d8-788b-4cc7-e063-6294a90a1696 2026-01-29 Warnings Exact identifier application number: M017 MQUPIN Lidocaine Gel-Patch LIDOCAINE GEL-PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49703717-69a6-e480-e063-6394a90ac69c 2026-01-28 Warnings Exact identifier application number: M017 MQXUNMI LIDOCAINE Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 49706db7-bacd-190f-e063-6394a90a3a8e 2026-01-28 Warnings Exact identifier application number: M017 Joint and Muscle Relief Topical Analgesic MENTHOL Smart Cookie Solutions 1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d 2026-01-28 Warnings Exact identifier application number: M017 VonaFlex Effective Pain Relief Topical Analgesic LIDOCAINE HYDROCHLORIDE OPTIMAL LABORATORIES, LLC 0901244a-7d41-413a-b424-92a807532f28 2026-01-28 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Patch LIDOCAINE PAIN RELIEF Dynarex 960e4240-cd09-2560-e053-2a95a90a7bcf 2026-01-28 Warnings Exact identifier application number: M017 ALOE ICE SUNBURN RELIEF LIDOCAINE HYDROCHLORIDE Aloe Care International, LLC 56866fa8-052e-497c-a954-978d7d628949 2026-01-28 Warnings Exact identifier application number: M017 Walgreens Original Strength Anti Itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Walgreen Company a6a49dbb-74c7-47ca-88f2-3bb3d9acf914 2026-01-28 Warnings Exact identifier application number: M017 Flobow QUIT SMOKING Nicotine NICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINE Jiangxi Yudexi Pharmaceutical Co., LTD 495b10ce-3d2d-1aa4-e063-6294a90a4f35 2026-01-27 Warnings Exact identifier application number: M017 PAIN REUSEABLE PAIN Shenzhen Mengyue Technology Co., Ltd. 44e058fc-e1c0-742b-e063-6294a90ad225 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream Lavender MENTHOL Veridian Healthcare 495eb6e9-69da-f7b6-e063-6294a90accee 2026-01-27 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Cream MENTHOL Veridian Healthcare 49548ab2-267e-1e2a-e063-6394a90ab391 2026-01-27 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL Wal-Mart Stores, Inc. 03feaaef-7401-d464-e063-6294a90a2b2d 2026-01-27 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC 4a113699-1eb7-49b8-8cdf-2ad57db89b81 2026-01-27 Warnings Exact identifier application number: M017 Healthy Back Institute Rub On Relief ANALGESIC Fullstack Fulfillment 284c29a3-5722-ce70-e063-6394a90a7fa0 2026-01-26 Warnings Exact identifier application number: M017 Velocx for Joint and Muscle Pain Roll-On Applicator MENTHOL, METHYL SALICYLATE JMAD Consulting LLC, dba JMAD Labs dbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d21 2026-01-26 Warnings Exact identifier application number: M017 CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS CAPSAICIN Meijer Distribution Inc 9b91658f-c15f-4222-bbd9-881b29de3b6e 2026-01-26 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 Marketing end Sample Exclude flag Status 54859-202-04 54859020204 113 g in 1 JAR (54859-202-04) 113 g 2016-04-01 0000-00-00 No No Current