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  4. NDC Product Code: 69423-985 Vicks Zzzquil Night Pain

NDC 69423-985 Vicks Zzzquil Night Pain

Diphenhydramine Hydrochloride And Acetaminophen Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69423-985?
  5. Vicks Zzzquil Night Pain Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
69423-985
Proprietary Name:
Vicks Zzzquil Night Pain
Non-Proprietary Name: [1]
Diphenhydramine Hydrochloride And Acetaminophen
Substance Name: [2]
Acetaminophen; Diphenhydramine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - 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): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    The Procter & Gamble Manufacturing Company
    Labeler Code:
    69423
    Product Label ID:
    f3bb75e8-3d43-f91e-e053-2a95a90a584d
    FDA Application Number: [6]
    M010
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    03-03-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

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

    Product Packages

    NDC Code 69423-985-02

    Package Description: 2 BOTTLE in 1 CARTON / 354 mL in 1 BOTTLE

    NDC Code 69423-985-12

    Package Description: 354 mL in 1 BOTTLE

    Product Details

    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 69423-985-02 2 bottle in 1 carton / 354 ml in 1 bottle, 69423-985-12 354 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 and RxNorm crosswalk.

    What are the uses for Vicks Zzzquil Night Pain?

    Take only one dose (30 mL) per day (24 hours)only use the dose cup providedadults & children 12 yrs & over30 mL at bedtimechildren under 12 yrsdo not use

    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.

    Which are Vicks Zzzquil Night Pain UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are 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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Vicks Zzzquil Night Pain?

    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

    Which are the Pharmacologic Classes for Vicks Zzzquil Night Pain?

    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.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".