NDC 69842-938 Daytime And Nighttime Sinus Congestion PE

Diphenhydramine Hcl,Phenylephrine Hcl Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
69842-938
Proprietary Name:
Daytime And Nighttime Sinus Congestion PE
Non-Proprietary Name: [1]
Diphenhydramine Hcl, Phenylephrine Hcl
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]
Cvs Pharmacy
Labeler Code:
69842
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
06-10-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
BLUE (C48333)
Shape:
ROUND (C48348)
OVAL (C48345)
Size(s):
7 MM
11 MM
Imprint(s):
44;453
44;485
Score:
1

Product Packages

NDC Code 69842-938-09

Package Description: 1 KIT in 1 CARTON * 12 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK

Product Details

What is NDC 69842-938?

The NDC code 69842-938 is assigned by the FDA to the product Daytime And Nighttime Sinus Congestion PE which is a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Daytime And Nighttime Sinus Congestion PE is diphenhydramine hcl, phenylephrine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 69842-938-09 1 kit in 1 carton * 12 tablet, film coated in 1 blister pack * 8 tablet, film coated 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 Daytime And Nighttime Sinus Congestion PE?

Adults and children 12 years and overtake 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hourschildren under 12 years: ask a doctor

Which are Daytime And Nighttime Sinus Congestion PE UNII Codes?

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

Which are Daytime And Nighttime Sinus Congestion PE 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 Daytime And Nighttime Sinus Congestion PE?

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: 1049182 - phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1049182 - phenylephrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 1052928 - diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1052928 - diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 2639176 - {1 (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) / 1 (phenylephrine hydrochloride 10 MG Oral Tablet) } Pack

* Please review the disclaimer below.

Patient Education

Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* 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".