LEADER HYDROCORTISONE WITH ALOE

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: LEADER HYDROCORTISONE WITH ALOE
Generic name: HYDROCORTISONE
Manufacturer: LEADER
Product type: HUMAN OTC DRUG
SPL set ID: 39916470-15bf-4bd0-96e2-b909d68cf9c4
SPL ID: 0c7a5326-72c1-403e-9018-187e5619975f
Version: 5
Effective date: 2025-09-29
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:54:33

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		LEADER HYDROCORTISONE WITH ALOE	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		LEADER	openfda.manufacturer_name
ndc	package	70000-0543-1	openfda.package_ndc
ndc	product	70000-0543	openfda.product_ndc
ndc11	package	70000054301	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		0c7a5326-72c1-403e-9018-187e5619975f	id
spl set id		39916470-15bf-4bd0-96e2-b909d68cf9c4	set_id
unii		WI4X0X7BPJ	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Avoid contact with eyes. Do not use if you have a vaginal discharge. Consult a doctor. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days bleeding occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Reported adverse events (FAERS/openFDA)#

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