TheraCare 2% Diphenhydramine Anti-Itch Cream

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: TheraCare 2% Diphenhydramine Anti-Itch Cream
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE
Manufacturer: Veridian Healthcare
Product type: HUMAN OTC DRUG
SPL set ID: 5999b677-63dd-49c6-b5b8-7b3c117ecc5c
SPL ID: 4085ade5-ebd1-ed55-e063-6394a90a82cf
Version: 1
Effective date: 2025-10-06
Source export date: 2026-10-27
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/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:16:35

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		TheraCare 2% Diphenhydramine Anti-Itch Cream	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	openfda.generic_name
manufacturer name		Veridian Healthcare	openfda.manufacturer_name
ndc	package	71101-014-01	openfda.package_ndc
ndc	product	71101-014	openfda.product_ndc
ndc11	package	71101001401	derived:openfda.package_ndc
rxcui		1087026	openfda.rxcui
spl id		4085ade5-ebd1-ed55-e063-6394a90a82cf	id
spl set id		5999b677-63dd-49c6-b5b8-7b3c117ecc5c	set_id
unii		FM5526K07A	openfda.unii
unii		TC2D6JAD40	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. 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 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.