NDC 30142-228 Maximum Strength Sleep Aid

Diphenhydramine Hcl

NDC Product Code 30142-228

NDC Code: 30142-228

Proprietary Name: Maximum Strength Sleep Aid 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):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
206
Score: 1

NDC Code Structure

  • 30142 - Kroger Company
    • 30142-228 - Maximum Strength Sleep Aid

NDC 30142-228-32

Package Description: 1 BOTTLE in 1 CARTON > 32 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC 30142-228-40

Package Description: 1 BOTTLE in 1 CARTON > 40 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC 30142-228-64

Package Description: 1 BOTTLE in 1 CARTON > 64 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

Maximum Strength Sleep Aid with NDC 30142-228 is a a human over the counter drug product labeled by Kroger Company. The generic name of Maximum Strength Sleep Aid is diphenhydramine hcl. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Kroger Company

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

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.

Maximum Strength Sleep Aid 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 50 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.

  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: 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: 04-17-2019 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.

Maximum Strength Sleep Aid 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

DISTRIBUTED BY THE KROGER CO.


CINCINNATI, OHIO 45202


GLUTEN FREE

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

For the relief of occasional sleeplessness

Otc - Do Not Use

  • Do not usefor children under 12 years of agewith any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor

  • Ask a doctor before use if you havea breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged 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 drinks

Otc - Stop Use

Stop use and ask a doctor ifsleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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. 1-800-222-1222

Directions

  • Adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor

Inactive Ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

* Please review the disclaimer below.

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