DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML

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: DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
Generic name: DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
Manufacturer: AARNA USA INC.
Product type: HUMAN OTC DRUG
SPL set ID: 32c26835-f54e-d7e5-e063-6294a90ae1c0
SPL ID: 3404aa22-166f-5501-e063-6394a90a1e7a
Version: 3
Effective date: 2025-04-30
Source export date: 2026-10-27
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:59:57

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	openfda.brand_name
generic name		DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	openfda.generic_name
manufacturer name		AARNA USA INC.	openfda.manufacturer_name
ndc	package	82568-0016-8	openfda.package_ndc
ndc	package	82568-0016-6	openfda.package_ndc
ndc	package	82568-0016-4	openfda.package_ndc
ndc	product	82568-0016	openfda.product_ndc
ndc11	package	82568001608	derived:openfda.package_ndc
ndc11	package	82568001606	derived:openfda.package_ndc
ndc11	package	82568001604	derived:openfda.package_ndc
rxcui		1049906	openfda.rxcui
spl id		3404aa22-166f-5501-e063-6394a90a1e7a	id
spl set id		32c26835-f54e-d7e5-e063-6294a90ae1c0	set_id
unii		8GTS82S83M	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 product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitabillty may occur, especially in children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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