NDC 59726-866 Allergy Relief

Diphenhydramine Hcl

NDC Product Code 59726-866

NDC Code: 59726-866

Proprietary Name: Allergy Relief 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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: CAPSULE (C48336)
Size(s):
11 MM
Imprint(s):
T;061
Score: 1

NDC Code Structure

  • 59726 - P & L Development, Llc
    • 59726-866 - Allergy Relief

NDC 59726-866-40

Package Description: 400 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Allergy Relief with NDC 59726-866 is a a human over the counter drug product labeled by P & L Development, Llc. The generic name of Allergy Relief is diphenhydramine hcl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: P & L Development, Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1

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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: P & L Development, Llc
Labeler Code: 59726
FDA Application Number: part336 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: 07-31-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Allergy Relief 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  sneezing  itchy, watery eyes itching of the nose or throattemporarily relieves these symptoms due to the common cold: runny nose  sneezing

Do Not Use

  • To make a child sleepy 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 bronchitisglaucomatrouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

Taking sedatives or tranquilizers

When Using This Product

  • Marked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

If Pregnant Of 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 (1-800-222-1222) right away.

Directions

  • Take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hoursadults and children 12 years and overtake 1 to 2 tablets children 6 to under 12 years take 1 tablet children under 6 years do not use

Other Information

  • Each tablet contains: calcium 25 mgstore between 20-25ºC (68-77ºF)protect from light and moisture

Inactive Ingredients

Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Product Label

READYinCASE Allergy Relief Tablets

* Please review the disclaimer below.

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