Nighttime Cold and Flu

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: Nighttime Cold and Flu
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Manufacturer: Grocery Outlet, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4d887ed0-4532-5125-e063-6394a90ac44d
SPL ID: 4d887edb-39d1-505e-e063-6394a90a1748
Version: 1
Effective date: 2026-03-24
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:49:03

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Nighttime Cold and Flu	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	openfda.generic_name
manufacturer name		Grocery Outlet, Inc.	openfda.manufacturer_name
ndc	package	85828-750-01	openfda.package_ndc
ndc	product	85828-750	openfda.product_ndc
ndc11	package	85828075001	derived:openfda.package_ndc
rxcui		1043400	openfda.rxcui
spl id		4d887edb-39d1-505e-e063-6394a90a1748	id
spl set id		4d887ed0-4532-5125-e063-6394a90ac44d	set_id
unii		9D2RTI9KYH	openfda.unii
unii		V9BI9B5YI2	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 -more than 4 doses in 24 hours, which is the maximum daily amount for this product -with other drugs containing acetaminophen -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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Reported adverse events (FAERS/openFDA)#

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