NDC 0536-1214 Diphenhydramine Hcl

Diphenhydramine Hcl

NDC Product Code 0536-1214

NDC CODE: 0536-1214

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: OVAL (C48345)
Size(s):
11 MM
Imprint(s):
44;329
Score: 1

NDC Code Structure

  • 0536 - Rugby Laboratories

NDC 0536-1214-29

Package Description: 100 TABLET, COATED in 1 BOTTLE, PLASTIC

Price per Unit: $0.03558 per EA

NDC Product Information

Diphenhydramine Hcl with NDC 0536-1214 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Diphenhydramine Hcl is diphenhydramine hcl. The product's dosage form is tablet, coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1049630.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

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: Rugby Laboratories
Labeler Code: 0536
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: 03-28-2019 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".

* Please review the disclaimer below.

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 Tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nose  itchy, watery eyessneezing itching of the nose or throattemporarily relieves these symptoms due to the common cold: runny nose sneezing

Do Not Use

  • With any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • A breathing problem such as emphysema or chronic bronchitis glaucomadifficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers.

When Using This Product

  • Marked drowsiness may occuralcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beveragesuse caution when driving a motor vehicle or operating machineryexcitability may occur, especially in children

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

  • Do not take more than directedtake every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursadults and children 12 yearsand over1 to 2 tabletschildren 6 to under 12 years1 tabletchildren under 6 yearsdo not use

Other Information

  • Each tablet contains: calcium 30 mgstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moistureuse by expiration date on package

Inactive Ingredients

Corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

* Please review the disclaimer below.