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: Better Living Brands, LLC
Product type: HUMAN OTC DRUG
SPL set ID: fc07d516-9ffe-9989-e053-6294a90ae1a5
SPL ID: 0b35e6d7-d8ed-de5d-e063-6394a90a1777
Version: 2
Effective date: 2023-11-28
Source export date: 2026-10-30
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/2026-10-30/eb45a4bb6908a5d117668eac8da5ce490c753c3f9b68298758ef131307d1d264/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:17:08

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 · 14 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		Better Living Brands, LLC	openfda.manufacturer_name
ndc	package	21130-224-18	openfda.package_ndc
ndc	package	21130-224-73	openfda.package_ndc
ndc	product	21130-224	openfda.product_ndc
ndc11	package	21130022473	derived:openfda.package_ndc
ndc11	package	21130022418	derived:openfda.package_ndc
rxcui		1092189	openfda.rxcui
spl id		0b35e6d7-d8ed-de5d-e063-6394a90a1777	id
spl set id		fc07d516-9ffe-9989-e053-6294a90ae1a5	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.