NDC 30142-229 Ez Nite Sleep

Diphenhydramine Hydrochloride

NDC Product Code 30142-229

NDC Code: 30142-229

Proprietary Name: Ez Nite Sleep 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):
PURPLE (C48327)
Shape: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
602
Score: 1

Code Structure
  • 30142 - The Kroger Co.
    • 30142-229 - Ez Nite Sleep

NDC 30142-229-24

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

NDC Product Information

Ez Nite Sleep with NDC 30142-229 is a a human over the counter drug product labeled by The Kroger Co.. The generic name of Ez Nite Sleep is diphenhydramine hydrochloride. The product's dosage form is capsule and is administered via oral form.

Labeler Name: The Kroger Co.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.


Ez Nite Sleep 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • 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: The Kroger Co.
Labeler Code: 30142
FDA Application Number: part338 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: 04-25-2019 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.

Ez Nite Sleep Product Label Images

Ez Nite Sleep 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

Other

Drug Facts

Drug Facts (continued)

Drug Facts (continued)

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25mg

Purpose

Nighttime sleep-aid

Uses

  • For the relief of occasional sleeplessnessreduces time to fall asleep if you have difficulty falling asleep

Warnings

Warnings

Do Not Use

  • For children under 12 years of agewith 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 bronchitisglaucomadifficulty in urination due to enlargement of prostate gland

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

  • When using this product avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • Take only one dose per day (24 hours) adults & children 12 years & over    One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor children under 12 years    Do not use

Other Information

  • Store at 20-25° C (68-77° F)avoid excessive heat above 40° C (104° F)Protect from light

Inactive Ingredients

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Otc - Questions

Questions or comments? 1-800-632-6900

* Please review the disclaimer below.

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