NDC 70000-0585 Allergy Relief Diphenhydramine Hcl

Diphenhydramine Hydrochloride

NDC Product Code 70000-0585

NDC CODE: 70000-0585

Proprietary Name: Allergy Relief 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 Hydrochloride 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.

NDC Code Structure

  • 70000 - Cardinal Health 110, Llc. Dba Leader
    • 70000-0585 - Allergy Relief Diphenhydramine Hcl

NDC 70000-0585-1

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Allergy Relief Diphenhydramine Hcl with NDC 70000-0585 is a a human over the counter drug product labeled by Cardinal Health 110, Llc. Dba Leader. The generic name of Allergy Relief Diphenhydramine Hcl is diphenhydramine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1049909.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Allergy Relief 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.

  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)

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: Cardinal Health 110, Llc. Dba Leader
Labeler Code: 70000
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: 09-15-2021 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.

Allergy Relief Diphenhydramine Hcl Product Label Images

Allergy Relief 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 Softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use •to make a child sleepy •with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you have•a breathing problem such as emphysema or chronic bronchitis •glaucoma •difficulty in urination due to enlargement to the prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.When using this product•marked drowsiness may occur•avoid alcoholic beverages•alcohol, sedatives, and tranquilizers may increase drowsiness•use caution when driving a motor vehicle or operating machinery•excitability may occur, especially in childrenIf pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

•take every 4 to 6 hours, or as directed by a doctor•do not take more than 6 doses in 24 hoursadults and children 12 years and older 1 to 2 softgelschildren 6 to under 12 years 1 softgelchildren under 6 years do not use

Other Information

•store at 25°C (77°F) in a dry place•protect from light, heat and moisture

Inactive Ingredients

Edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

* Please review the disclaimer below.