NDC 79481-0030 Cold And Flu Non Drowsy Daytime And Nighttime

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate,Phenylephrine - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
79481-0030
Proprietary Name:
Cold And Flu Non Drowsy Daytime And Nighttime
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Meijer, Inc.
Labeler Code:
79481
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
09-19-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
GREEN (C48329)
Shape:
OVAL (C48345)
Size(s):
21 MM
Imprint(s):
512;A09;AP01
116;A07;AP02
Score:
1

Product Packages

NDC Code 79481-0030-4

Package Description: 1 KIT in 1 CARTON * 4 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Product Details

What is NDC 79481-0030?

The NDC code 79481-0030 is assigned by the FDA to the product Cold And Flu Non Drowsy Daytime And Nighttime which is a human over the counter drug product labeled by Meijer, Inc.. The generic name of Cold And Flu Non Drowsy Daytime And Nighttime is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 79481-0030-4 1 kit in 1 carton * 4 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack * 2 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack. 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 Cold And Flu Non Drowsy Daytime And Nighttime?

● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing Directions (Daytime only) ● take only as directed - see Overdose warning ● do not exceed 4 doses per 24 hours adults & children 12 years & overtake 2 softgels with water every 4 hourschildren 4 to under 12 yearsask a doctorchildren under 4 years of agedo not use ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing Directions (Nighttime only) ● take only as directed - see Overdose warning ● do not exceed 4 doses per 24 hours adults & children 12 years & overtake 2 softgels with water every 6 hourschildren 4 to under 12 yearsask a doctorchildren under 4 years of agedo not use

Which are Cold And Flu Non Drowsy Daytime And Nighttime UNII Codes?

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

Which are Cold And Flu Non Drowsy Daytime And Nighttime 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 Cold And Flu Non Drowsy Daytime And Nighttime?

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: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule

* 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.

[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.

[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".