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 29 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr.Harry COMFORT ZONE Cream LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4d32b89f-72e8-bc93-e063-6394a90a0bc8 2026-03-17 Warnings Exact identifier application number: M017 MiloRod Ultra Muscle Rub Fast-Acting Pain Relief CAPSAICIN, MENTHOL Milo Rod Import & Export, Inc. c3622dc3-0c05-47c9-b70b-498946781906 2026-03-17 Warnings Exact identifier application number: M017 Walgreens Burn Pad BURN PAD Walgreens 3f8d7624-cf1e-1992-e063-6294a90a3806 2026-03-17 Boxed warning, Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Mericon Industries 8f351b04-8f6d-4353-9100-13a8a80d656a 2026-03-17 Warnings Exact identifier application number: M017 Shoe Pain Relief LIDOCAINE HCI 4% Sole Amie 0f2ccd5f-b9f4-40fc-b82f-173b0f19bf40 2026-03-16 Warnings Exact identifier application number: M017 CVS Muscle Balm MENTHOL, CAMPHOR CVS Health 42796fc4-03be-3b02-e063-6394a90af2ab 2026-03-16 Warnings Exact identifier application number: M017 Crane Safety Hydrocortisone HYDROCORTISONE Crane Safety LLC 96d9527d-9bf7-ce82-e053-2995a90aff0c 2026-03-16 Warnings Exact identifier application number: M017 CVS Health Pain Relief Foot MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 0f646876-69d0-49db-ade2-2b3eb26dd399 2026-03-16 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Foot Cream MENTHOL Walgreen Co. 3bc8ece3-d555-3efb-e063-6394a90a1981 2026-03-16 Warnings Exact identifier application number: M017 RICHTOFIT RAPID ACTIVE LEG AND FOOT MENTHOL RICHTOFIT LIMITED LIABILITY COMPANY 4c357696-ca96-e6ad-e063-6294a90aaadb 2026-03-16 Warnings Exact identifier application number: M017 Xpect Stopain Clinical MENTHOL Cintas Corporation 348e6062-b31e-435e-a153-6aa868b50efa 2026-03-13 Warnings Exact identifier application number: M017 DGH GREASELESS MUSCLE RUB ANALGESIC MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE DOLLAR GENERAL 225abfe0-ec72-4667-96b2-7657e989672b 2026-03-13 Warnings Exact identifier application number: M017 CVS Professional Pain Relief MENTHOL CVS Pharmacy 48836a5b-0baa-b7ee-e063-6294a90ac12b 2026-03-13 Warnings Exact identifier application number: M017 Keeps Climax Delay LIDOCAINE HYDROCHLORIDE Cosco International, Inc. 3bfd3173-2dac-40a9-aec3-982b1d47d8fa 2026-03-12 Warnings Exact identifier application number: M017 NanoX Pain Relieving MENTHOL, METHYL SALICYLATE MG Science Technologies LLC 4cc38927-8a8c-2df3-e063-6294a90aa0c1 2026-03-12 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4cd4c51c-88bb-3797-e063-6294a90a8f70 2026-03-12 Warnings Exact identifier application number: M017 CVS Lidocaine Pain Relief LIDOCAINE HYDROCHLORIDE, MENTHOL CVS Pharmacy 48c045ae-56b5-62c2-e063-6394a90aaf44 2026-03-12 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE ProStat First Aid 4cd62cba-075a-7448-e063-6394a90ab48d 2026-03-12 Warnings Exact identifier application number: M017 Medicated Pain Relief Patch CAMPHOR, MENTHOL, METHYL SALICYLATE Kroger Company 47cc4b05-a937-4624-bf41-85b8bd7c049e 2026-03-12 Warnings Exact identifier application number: M017 Lidocaine HCL LIDOCAINE HCL Matthias Therapeutics, LLC 4cdb27b5-9178-0328-e063-6394a90a50b5 2026-03-12 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