NDC 66267-081 Diphenhydramine Hcl

Diphenhydramine Hcl

NDC Product Code 66267-081

NDC CODE: 66267-081

Proprietary Name: Diphenhydramine Hcl What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diphenhydramine Hcl 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.

Product Characteristics

Color(s):
PINK (C48328)
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
PH013
Score: 1

NDC Code Structure

  • 66267 - Nucare Pharmaceuticals, Inc.

NDC 66267-081-30

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Diphenhydramine Hcl with NDC 66267-081 is a a human over the counter drug product labeled by Nucare Pharmaceuticals, Inc.. The generic name of Diphenhydramine Hcl is diphenhydramine hcl. The product's dosage form is capsule and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1020477.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Otc Drug 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.

Diphenhydramine Hcl Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Nucare Pharmaceuticals, Inc.
Labeler Code: 66267
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 01-27-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

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Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
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 als...
[Read More]

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Diphenhydramine Hcl Product Label Images

Diphenhydramine Hcl Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient(In Each Capsule)

Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.Sneezing.Nasal congestion.Runny nose.Itchy, watery eyes.

Do Not Use

  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask A Doctor Or Pharmacist Before Use

  • If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf you are taking sedatives or tranquilizers

When Using This Product

  • Avoid alcoholic drinks.Marked drowsiness may occur.Excitability may occur, especially in children.Alcohol, sedatives and tranquilizers may
  • Increase drowsiness.Be
  • Careful when driving a motor vehicle or operating machinery.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away

Directions:

  • Take every 4-6 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over
  • 1 capsule
  • Children under 12 years
  • Ask a doctor
  • **25 mg strength is not available in this package. Do not attempt to break capsules

Other Information:

  • Store at room temperature 15-30  degrees C (59-86 degrees F)Protect from excessive moisture

Questions? Adverse Drug Event Call:

1-800-687-0176

* Please review the disclaimer below.