NDC 41226-160 Allergy

Diphenhydramine Hydrochloride

NDC Product Code 41226-160

NDC CODE: 41226-160

Proprietary Name: Allergy 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.

Product Characteristics

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

NDC Code Structure

NDC 41226-160-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE

NDC 41226-160-40

Package Description: 1 BOTTLE in 1 CARTON > 400 TABLET, FILM COATED in 1 BOTTLE

NDC 41226-160-42

Package Description: 1 BLISTER PACK in 1 CARTON > 12 BLISTER PACK in 1 BLISTER PACK > 12 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Allergy with NDC 41226-160 is a a human over the counter drug product labeled by Kroger Company. The generic name of Allergy is diphenhydramine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Kroger Company

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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 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.

  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • 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: Kroger Company
Labeler Code: 41226
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: 05-11-2021 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 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

Diphenhydramine HCl 25 mg

Otc - Purpose

Antihistamine

Indications & Usage

  • Uses
  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Runny noseitchy, watery eyessneezingitchy nose or throattemporarily relieves these symptoms due to the common cold:runny nosesneezing

Warnings

  • WarningsDo not useto make a child sleepywith any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

  • Ask a doctor before use if you haveglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitis

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Otc - When Using

  • When using this productmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessexcitability may occur, especially in childrenbe careful when driving a motor vehicle or operating machinery

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 ot children. In case of overdose, get medical help or contact a Poison Control Center right away(l-800-222-1222).

Dosage & Administration

  • Directionstake every 4 to 6 hoursdo not take more than 6 doses in 24 hoursadults and children 12 years of age and over 1 to 2 caplets
  • Children 6 to under 12 years of age 1 caplet
  • Children under 6 years of age do not use this product in children under 6 years of age

Other Information

  • Other informationeach caplet contains: calcium 25 mg
  • Protect from lightstore at 25°C (77°F) excursions permitted 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredient

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 (PEG) 400, polysorbate 80, titanium dioxide

Otc - Questions

Questions or comments?1-800-632-6900

* Please review the disclaimer below.