FDA label 3428e1ed-77f3-451f-b271-9f00e5a2cabd

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)

SPL set ID: 61ffe0a0-3fc3-45a1-b813-9cb3ce730a45
SPL ID: 3428e1ed-77f3-451f-b271-9f00e5a2cabd
Version: 3
Effective date: 2020-12-02
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:22:39

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		3428e1ed-77f3-451f-b271-9f00e5a2cabd	id
spl set id		61ffe0a0-3fc3-45a1-b813-9cb3ce730a45	set_id

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 Do not use • on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use • on chicken pox • on measles When using this product • avoid contact with the 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.