Acetaminophen and Diphenhydramine hydrochloride

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: Acetaminophen and Diphenhydramine hydrochloride
Generic name: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer: KROGER COMPANY
Product type: HUMAN OTC DRUG
SPL set ID: b9b86755-63ad-e25a-e053-2995a90ad747
SPL ID: 539e230b-aef0-4660-915d-b03b90d647d0
Version: 5
Effective date: 2024-09-10
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:25:37

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Acetaminophen and Diphenhydramine hydrochloride	openfda.brand_name
generic name		ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		KROGER COMPANY	openfda.manufacturer_name
ndc	package	30142-193-14	openfda.package_ndc
ndc	product	30142-193	openfda.product_ndc
ndc11	package	30142019314	derived:openfda.package_ndc
rxcui		1092189	openfda.rxcui
spl id		539e230b-aef0-4660-915d-b03b90d647d0	id
spl set id		b9b86755-63ad-e25a-e053-2995a90ad747	set_id
unii		TC2D6JAD40	openfda.unii
unii		362O9ITL9D	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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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