Pramosone Cream

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Pramosone Cream
Generic name: HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE
Manufacturer: Legacy Pharma USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 6a9fb75b-a2f7-4eca-8dce-d7eb5c122476
SPL ID: 38cf2148-3f22-d6dd-e063-6394a90a5dbd
Version: 1
Effective date: 2025-06-30
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:41:50

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	085368	derived:openfda.application_number
application number		ANDA085368	openfda.application_number
brand name		Pramosone Cream	openfda.brand_name
generic name		HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Legacy Pharma USA Inc.	openfda.manufacturer_name
ndc	package	83107-017-01	openfda.package_ndc
ndc	package	83107-016-02	openfda.package_ndc
ndc	product	83107-017	openfda.product_ndc
ndc	product	83107-016	openfda.product_ndc
ndc11	package	83107001602	derived:openfda.package_ndc
ndc11	package	83107001701	derived:openfda.package_ndc
rxcui		1234519	openfda.rxcui
rxcui		1116499	openfda.rxcui
spl id		38cf2148-3f22-d6dd-e063-6394a90a5dbd	id
spl set id		6a9fb75b-a2f7-4eca-8dce-d7eb5c122476	set_id
unii		88AYB867L5	openfda.unii
unii		3X7931PO74	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS : The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

adverse reactions table

<table width="450" styleCode="Noautorules"><col align="left" width="30%"/><col align="left" width="35%"/><col align="left" width="35%"/><tbody><tr><td>Burning</td><td>Hypertrichosis</td><td>Maceration of the skin</td></tr><tr><td>Itching</td><td>Acneiform eruptions</td><td>Secondary infection</td></tr><tr><td>Irritation</td><td>Hypopigmentation</td><td>Skin atrophy</td></tr><tr><td>Dryness</td><td>Perioral dermatitis</td><td>Striae</td></tr><tr><td>Folliculitis</td><td>Allergic contact dermatitis</td><td>Miliaria</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.