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  4. NDC Product Code: 63868-464 Daytime Sinus Relief And Nighttime Sinus Relief

NDC 63868-464 Daytime Sinus Relief And Nighttime Sinus Relief

Acetaminophen,Doxylamine Succinate,Phenylephrine Hydrochloride Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63868-464?
  5. Daytime Sinus Relief And Nighttime Sinus Relief Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
63868-464
Proprietary Name:
Daytime Sinus Relief And Nighttime Sinus Relief
Non-Proprietary Name: [1]
Acetaminophen, 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]
Chain Drug Marketing Association Inc.
Labeler Code:
63868
Product Label ID:
d538445e-a47d-4983-844f-38aa303d11fd
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
04-12-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - CLEAR)
BLUE (C48333 - CLEAR)
Shape:
CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
PC12
PC13
Score:
1

Product Packages

NDC Code 63868-464-48

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 63868-464?

The NDC code 63868-464 is assigned by the FDA to the product Daytime Sinus Relief And Nighttime Sinus Relief which is a human over the counter drug product labeled by Chain Drug Marketing Association Inc.. The generic name of Daytime Sinus Relief And Nighttime Sinus Relief is acetaminophen, doxylamine succinate, phenylephrine hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63868-464-48 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 Daytime Sinus Relief And Nighttime Sinus Relief?

Take only as directeddo not exceed 4 doses per 24 hoursAgeDaytime SinusNighttime Sinusadults and children 12 years and over2 softgels with water every 4 hours2 softgels with water every 4 hourschildren 4 to under 12 yearsask a doctorask a doctorchildren under 4 yearsdo not usedo not use

Which are Daytime Sinus Relief And Nighttime Sinus Relief UNII Codes?

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

Which are Daytime Sinus Relief And Nighttime Sinus Relief 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 Sinus Relief And Nighttime Sinus Relief?

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: 1052647 - acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1052647 - acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1052647 - APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
  • RxCUI: 1052670 - acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1052670 - acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule

* Please review the disclaimer below.

Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]


Doxylamine


Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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".