hydrocortisone acetate pramoxine hcl

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: hydrocortisone acetate pramoxine hcl
Generic name: HYDROCORTISONE ACETATE PRAMOXINE HCL
Manufacturer: Bryant Ranch Prepack
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3c5e1833-9908-4e4f-bdf2-7a28c14a585c
SPL ID: 8172f406-59b6-4b90-8ffd-f408d1799b71
Version: 104
Effective date: 2023-07-18
Source export date: 2026-10-22
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-22/1e745e0906b899af47c88f3dead6beee5ae51229b555f30f1c85dfc349b0fede/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run: 20261023T001338Z
Imported at: 2026-10-23 01:21:28

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 · 13 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		hydrocortisone acetate pramoxine hcl	openfda.brand_name
generic name		HYDROCORTISONE ACETATE PRAMOXINE HCL	openfda.generic_name
manufacturer name		Bryant Ranch Prepack	openfda.manufacturer_name
ndc	package	63629-8669-1	openfda.package_ndc
ndc	product	63629-8669	openfda.product_ndc
ndc11	package	63629866901	derived:openfda.package_ndc
rxcui		1235049	openfda.rxcui
spl id		8172f406-59b6-4b90-8ffd-f408d1799b71	id
spl set id		3c5e1833-9908-4e4f-bdf2-7a28c14a585c	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 · 1 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 Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

Reported adverse events (FAERS/openFDA)#

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