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 146 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NATURES CRAFT LIDOCAINE Male Genital Desensitizer LIDOCAINE HYDROCHLORIDE Natures Design Products LLC 61bf1776-5c6c-4307-8348-41fa60164017 2023-11-11 Warnings Exact identifier application number: M017 CLEAN REMEDIES CR PAIN RELIEF MENTHOL Clean Remedies, LLC aea9291d-3244-401c-9607-e91107228faa 2023-11-11 Warnings Exact identifier application number: M017 Arth Arrest METHYL NICOTINATE, CAPSAICIN Key 2 Health, Inc. 495034ac-dbf5-4c55-906b-6ffcbcfd5bc2 2023-11-11 Warnings Exact identifier application number: M017 KINETIC ICE Muscle and Joint Pain Relief Cream MENTHOL No Reason, LLC 565f0e20-e534-41db-ba20-e726d578405f 2023-11-11 Warnings Exact identifier application number: M017 KARMA RUB Elemental Pain Relief LIDOCAINE HYDROCHLORIDE Elemental Bliss LLC c224fb1b-827f-461e-a58f-4020700c3e0d 2023-11-11 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief with Hemp Seed HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 46415d28-99b5-4c9e-bde9-1c703595f671 2023-11-11 Warnings Exact identifier application number: M017 Dr PAINES Pain Relief MENTHOL DOCTOR PAINE'S MEDICAL, LLC 79d2b332-051e-48c1-afe8-6d4468cd1878 2023-11-11 Warnings Exact identifier application number: M017 INTIMALE Maximum Strength Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25b9ade3-72b0-4b86-8c48-90310a26806f 2023-11-11 Warnings Exact identifier application number: M017 POWERECT Max Power Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25a1c926-9543-44a7-865e-a4b6e1a40cbe 2023-11-11 Warnings Exact identifier application number: M017 SKINS DELAY Maximum Strength Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 172efe5d-28b8-443c-b3f9-429669189081 2023-11-11 Warnings Exact identifier application number: M017 GASPARI Ageless Pain Relief Cream MENTHOL GASPARI ANTI-AGING LLC ea806089-688b-4944-ad69-86f366509eb5 2023-11-11 Warnings Exact identifier application number: M017 ZENSEZONE Arthmed Temporary Pain Relief Cream CAPSAICIN, MENTHOL, METHYL SALICYLATE ZENSEZONE LLC c5778f22-c411-4bd7-b2af-45e3fee15fd2 2023-11-11 Warnings Exact identifier application number: M017 PRFC HEMP Topical Analgesic MENTHOL DOBEST INC 722da9d1-91d7-45be-adb1-8d6a22aa83ac 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 84ea496e-ab54-4882-93ef-600f8eb33cb4 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 39564c67-49ab-42d4-a391-792ac69180c0 2023-11-11 Warnings Exact identifier application number: M017 LIDOSOLVE PAIN RELIEF LIDOCAINE HYDROCHLORIDE HENNIKA HEALTH, LLC 3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2 2023-11-11 Warnings Exact identifier application number: M017 AMINO ACTIVE Topical Analgesic Cream HISTAMINE DIHYDROCHLORIDE VIREO SYSTEMS, INC. 591b1e7e-a8c0-4640-a592-4e0f3538a40e 2023-11-11 Warnings Exact identifier application number: M017 NERVE ACTIVE Pain Relief Cream MENTHOL TOP DOG DIRECT, LLC a8b85dcb-fd3e-4340-a945-609fc741443c 2023-11-11 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Arm and Neck MENTHOL Geri-Gentle Corporation e4429f70-667e-662b-e053-2a95a90a62ba 2023-11-10 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