NDC 54859-811 Allergy Relief

Diphenhydramine Hcl

NDC Product Code 54859-811

NDC 54859-811-16

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Allergy Relief with NDC 54859-811 is a a human over the counter drug product labeled by Llorens Pharmaceuticals International Division. The generic name of Allergy Relief is diphenhydramine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Llorens Pharmaceuticals International Division

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.


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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)
  • SUCROSE (UNII: C151H8M554)

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.
  • 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: Llorens Pharmaceuticals International Division
Labeler Code: 54859
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: 10-01-2019 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’.

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Information for Patients


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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Allergy Relief Product Label Images

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

Otc - Active Ingredient

Active ingredient (in each 5 mL teaspoonful)Diphenhydramine HCl 12.5 mg

Otc - Purpose


Indications & Usage

  • UsesTemporarily relieves these symptoms of hay fever or other upper respiratory allergies:runny noseitchy nose or throatsneezingitchy, watery eyesTemporarily relieves these symptoms due to the common cold:runny nosesneezing


  • WarningsDo not usewith any other product conatining diphenhydramine, including one used on the skinto make a child sleepyAsk a doctor before use if you havea breathing problem such as chronic bronchitis or emphysematrouble urinating due to enlarged prostate glandglaucomaAsk a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.When using this productexcitability may occur, especially in childrenmarked drowsiness may occurbe careful when driving motor vehicle or operating machineryavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsiness

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsdo not exceed recommended dosetake every 4 to 6 hours as needed, or as directed by a doctordo not take more than 6 doses in 24 hoursadults and children 12 years and over: 10 to 20 mL (2 to 4 teaspoonful)children under 12 years: consult a doctor

Inactive Ingredient

Inactive ingredients: Artificial and natural cherry flavor, citric acid, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose and sucrose.

Otc - Questions

Questions or comments? 1-800-540-3765

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