CAREALL Diphenhydramine

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: CAREALL Diphenhydramine
Generic name: DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer: New World Imports, Inc
Product type: HUMAN OTC DRUG
SPL set ID: f3b177ef-55d5-4525-bf33-99205c414a5b
SPL ID: 468f82b6-9289-2198-e063-6294a90aa614
Version: 5
Effective date: 2025-12-22
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:54

Harmonized routes table
Harmonized routes
ORAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		CAREALL Diphenhydramine	openfda.brand_name
generic name		DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		New World Imports, Inc	openfda.manufacturer_name
ndc	package	51824-056-01	openfda.package_ndc
ndc	product	51824-056	openfda.product_ndc
ndc11	package	51824005601	derived:openfda.package_ndc
rxcui		1049630	openfda.rxcui
spl id		468f82b6-9289-2198-e063-6294a90aa614	id
spl set id		f3b177ef-55d5-4525-bf33-99205c414a5b	set_id
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 Do not use with any other products containing diphenhydramine, including ones used on skin Ask a doctor before use if you have : A breathing problem such as emphysema or chronic bronchitis Glaucoma Trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product: Marked drowsiness may occur Avoid alcoholic beverages Alcohol, sedatives, and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery Excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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