Vicks NyQuil HOT REMEDY 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: Vicks NyQuil HOT REMEDY Cold and Flu
Generic name: ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer: Procter & Gamble Manufactura S de RL de CV
Product type: HUMAN OTC DRUG
SPL set ID: 4535d4fe-9de7-f2c6-e063-6394a90a944a
SPL ID: 4535d508-ff3e-13ae-e063-6394a90a15de
Version: 1
Effective date: 2025-12-05
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:27:26

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		M012	openfda.application_number
brand name		Vicks NyQuil HOT REMEDY Cold and Flu	openfda.brand_name
generic name		ACETAMINOPHEN, DIPHENHYDRAMINE HCL	openfda.generic_name
manufacturer name		Procter & Gamble Manufactura S de RL de CV	openfda.manufacturer_name
ndc	package	58933-555-08	openfda.package_ndc
ndc	package	58933-555-01	openfda.package_ndc
ndc	product	58933-555	openfda.product_ndc
ndc11	package	58933055501	derived:openfda.package_ndc
ndc11	package	58933055508	derived:openfda.package_ndc
rxcui		2670677	openfda.rxcui
spl id		4535d508-ff3e-13ae-e063-6394a90a15de	id
spl set id		4535d4fe-9de7-f2c6-e063-6394a90a944a	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 more than 6 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.