dermagesic

Generic: pramoxine hcl, zinc oxide, calamine

Labeler: llorens pharmaceutical international division
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dermagesic
Generic Name pramoxine hcl, zinc oxide, calamine
Labeler llorens pharmaceutical international division
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

ferric oxide red 4 mg/g, pramoxine hydrochloride 10 mg/g, zinc oxide 4 mg/g

Manufacturer
Llorens Pharmaceutical International Division

Identifiers & Regulatory

Product NDC 54859-202
Product ID 54859-202_47467902-6ca7-2b20-e063-6394a90aeff1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2016-04-01

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54859202
Hyphenated Format 54859-202

Supplemental Identifiers

RxCUI
1798481
UNII
1K09F3G675 88AYB867L5 SOI2LOH54Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dermagesic (source: ndc)
Generic Name pramoxine hcl, zinc oxide, calamine (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 113 g in 1 JAR (54859-202-04)
source: ndc

Packages (1)

54859-202-04 113 g in 1 JAR (54859-202-04)

Ingredients (3)

ferric oxide red (4 mg/g) pramoxine hydrochloride (10 mg/g) zinc oxide (4 mg/g)

Linked Drug Pages (1)

Dermagesic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47467902-6ca7-2b20-e063-6394a90aeff1", "openfda": {"unii": ["1K09F3G675", "88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1798481"], "spl_set_id": ["bbff6b53-29da-45c1-8ccd-3e9df7f250e0"], "manufacturer_name": ["Llorens Pharmaceutical International Division"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 JAR (54859-202-04)", "package_ndc": "54859-202-04", "marketing_start_date": "20160401"}], "brand_name": "Dermagesic", "product_id": "54859-202_47467902-6ca7-2b20-e063-6394a90aeff1", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "54859-202", "generic_name": "Pramoxine HCl, Zinc Oxide, Calamine", "labeler_name": "Llorens Pharmaceutical International Division", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dermagesic", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "4 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}, {"name": "ZINC OXIDE", "strength": "4 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160401", "listing_expiration_date": "20261231"}