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, DOXYLAMINE SUCCINATE
Manufacturer: Walgreen Company
Product type: HUMAN OTC DRUG
SPL set ID: 02e5f475-4e9f-2856-e063-6294a90a21fd
SPL ID: 494e1d98-d19b-7f9c-e063-6294a90ab6c5
Version: 3
Effective date: 2026-01-26
Source export date: 2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:57

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 · 12 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, DOXYLAMINE SUCCINATE	openfda.generic_name
manufacturer name		Walgreen Company	openfda.manufacturer_name
ndc	package	0363-9143-01	openfda.package_ndc
ndc	product	0363-9143	openfda.product_ndc
ndc11	package	00363914301	derived:openfda.package_ndc
spl id		494e1d98-d19b-7f9c-e063-6294a90ab6c5	id
spl set id		02e5f475-4e9f-2856-e063-6294a90a21fd	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 hrs, 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 skin reaction occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, persist 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.