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  4. NDC Product Code: 0573-0148 Advil Pm

NDC 0573-0148 Advil Pm

Diphenhydramine Hcl,Ibuprofen Capsule, Liquid Filled Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0573-0148?
  4. Advil Pm Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 0573-0148 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0573-0148
Proprietary Name:
Advil Pm
Non-Proprietary Name: [1]
Diphenhydramine Hcl, Ibuprofen
Substance Name: [2]
Diphenhydramine Hydrochloride; Ibuprofen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Haleon Us Holdings Llc
Labeler Code:
0573
Product Label ID:
405afdb4-c157-1d88-f232-848063ba4714
FDA Application Number: [6]
NDA021393
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
01-15-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
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Product Details

What is NDC 0573-0148?

The NDC code 0573-0148 is assigned by the FDA to the product Advil Pm which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Advil Pm is diphenhydramine hcl, ibuprofen. The product's dosage form is capsule, liquid filled and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0573-0148-06 1 bottle in 1 carton / 40 capsule, liquid filled in 1 bottle, 0573-0148-07 1 bottle in 1 carton / 80 capsule, liquid filled 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 Advil Pm?

Do not take more than directedadults and children 12 years and over: take 2 capsules at bedtimedo not take more than 2 capsules in 24 hours

What are Advil Pm 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.
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 - 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.
  • IBUPROFEN 200 mg/1 - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties

What is the NDC to RxNorm Crosswalk for Advil Pm?

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: 901814 - ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
  • RxCUI: 901814 - diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule

Which are the Pharmacologic Classes for Advil Pm?

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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".