FDA.reportPublic FDA data

H-Cold Sores Formula

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
H-Cold Sores Formula
Generic name
CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS
Manufacturer
Healing Natural Oils LLC
Product type
HUMAN OTC DRUG
SPL set ID
425bc0e8-c884-40cc-90e9-490e50f733c3
SPL ID
2906ca73-43de-2c24-e063-6294a90a7bf2
Version
8
Effective date
2024-12-11
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:19
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings: For external use only. Perform skin test prior to initial use. Do not use if pregnant or breastfeeding. Keep out of reach of children. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away. Discontinue use if irritation occurs. Consult a doctor if symptoms worsen after 7 days.

warnings table

<table ID="ic728d8da-35c2-4475-833b-9b060849cdb4" width="100%"><tbody><tr><td><paragraph><content styleCode="bold">For external use only.</content></paragraph><content styleCode="bold">Perform skin test prior to initial use. </content></td></tr></tbody></table>

warnings table

<table width="100%" ID="ic83e7d26-9c52-4c96-87c2-60039f6d5ee3"><tbody><tr><td>Discontinue use if irritation occurs.</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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