NDC 69423-985 Vicks Zzzquil Night Pain
Diphenhydramine Hydrochloride And Acetaminophen Liquid Oral

Product Information

What is NDC 69423-985?

The NDC code 69423-985 is assigned by the FDA to the product Vicks Zzzquil Night Pain which is a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Vicks Zzzquil Night Pain is diphenhydramine hydrochloride and acetaminophen. The product's dosage form is liquid and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 69423-985-12 354 ml in 1 bottle , 69423-985-24 2 bottle in 1 cello pack / 354 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code69423-985
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Vicks Zzzquil Night Pain
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Diphenhydramine Hydrochloride And Acetaminophen
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		The Procter & Gamble Manufacturing Company
Labeler Code69423
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		M010
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-03-2023
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Vicks Zzzquil Night Pain?


Product Characteristics

Color(s)RED (C48326)
Flavor(s)CHERRY (C73375)

Product Packages

NDC Code 69423-985-12

Package Description: 354 mL in 1 BOTTLE

NDC Code 69423-985-24

Package Description: 2 BOTTLE in 1 CELLO PACK / 354 mL in 1 BOTTLE

Product Details

What are Vicks Zzzquil Night Pain Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 1000 mg/30mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

Vicks Zzzquil Night Pain Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1092373 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG in 15 mL Oral Solution
  • RxCUI: 1092373 - acetaminophen 33.3 MG/ML / diphenhydramine hydrochloride 1.67 MG/ML Oral Solution
  • RxCUI: 1092373 - acetaminophen 1000 MG / diphenhydramine HCl 50 MG per 30 ML Oral Solution
  • RxCUI: 1092373 - acetaminophen 500 MG / diphenhydramine HCl 25 MG per 15 ML Oral Solution
  • RxCUI: 1092373 - APAP 33.3 MG/ML / Diphenhydramine Hydrochloride 1.67 MG/ML Oral Solution

Vicks Zzzquil Night Pain Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Vicks Zzzquil Night Pain Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

DIST. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202


Active Ingredients (In Each 30 Ml)



Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg


Purpose



Pain reliever

Nighttime sleep-aid


Uses



  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings



Liver warning: This product contains acetaminophen. Severe

liver damage may occur if you take

  • more than 4 doses (30 mL each) in 24 hours, which is the maimum 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


Otc - Do Not Use



Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.

Otc - Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Otc - When Using



When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Otc - Stop Use



Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • sleeplessness persists continuously for more than 2 weeks.

    • Insomnia may be a symptom of serious underlying medical illness.

    These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL at bedtime

    children under 12 yrs

    do not use


Other Information



  • each 30 mL contains: sodium 93 mg
  • store at no greater than 25° C and do not refrigerate

Inactive Ingredients



alcohol, citric acid, FD&C Red No. 40, flavors, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum.


Questions?



1-877-881-5813


Principal Display Panel - 354 Ml Bottle



VICKS ®

ZzzQuil™

NIGHT PAIN

NIGHTTIME SLEEP-AID

PAIN RELIEVER



Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

    • Black Cherry

    Not For Colds

    Alcohol 10%

    12 FL OZ (354 ml)

    985 - 985

    985 - 985


* Please review the disclaimer below.