Caladryl

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: Caladryl
Generic name: FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE
Manufacturer: Bausch Health US, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 67d4fd42-9fed-4238-9f5a-c9403abbcf20
SPL ID: 24add3ce-a1f0-0b6a-e063-6394a90a77c2
Version: 6
Effective date: 2024-10-17
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Caladryl	openfda.brand_name
generic name		FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Bausch Health US, LLC	openfda.manufacturer_name
ndc	package	0187-5465-06	openfda.package_ndc
ndc	product	0187-5465	openfda.product_ndc
ndc11	package	00187546506	derived:openfda.package_ndc
rxcui		1234532	openfda.rxcui
rxcui		1234533	openfda.rxcui
spl id		24add3ce-a1f0-0b6a-e063-6394a90a77c2	id
spl set id		67d4fd42-9fed-4238-9f5a-c9403abbcf20	set_id
unii		SOI2LOH54Z	openfda.unii
unii		1K09F3G675	openfda.unii
unii		88AYB867L5	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. When using this product do not get into eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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