NDC 68016-789 Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride

NDC Product Code 68016-789

NDC Code: 68016-789

Proprietary Name: Diphenhydramine Hydrochloride 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):
GRAY (C48324 - ENCAPSULATED GRAY COLOR TABLETS WITH BLUE GRAY OPAQUE AND PURPLE OPAQUE HARD GELATIN SHELLS)
Shape: OVAL (C48345)
Size(s):
16 MM
Imprint(s):
G15
Score: 1

NDC Code Structure

  • 68016 - Pharmacy Value Alliance, Llc
    • 68016-789 - Diphenhydramine Hydrochloride

NDC 68016-789-48

Package Description: 48 TABLET in 1 BOTTLE

NDC Product Information

Diphenhydramine Hydrochloride with NDC 68016-789 is a a human over the counter drug product labeled by Pharmacy Value Alliance, Llc. The generic name of Diphenhydramine Hydrochloride is diphenhydramine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Pharmacy Value Alliance, 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.

Diphenhydramine Hydrochloride 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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • AMMONIA (UNII: 5138Q19F1X)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • SHELLAC (UNII: 46N107B71O)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Pharmacy Value Alliance, Llc
Labeler Code: 68016
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: 03-15-2019 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: 12-31-2019 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.

Diphenhydramine Hydrochloride Product Label Images

Diphenhydramine Hydrochloride 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 gelcap)Diphenhydramine HCl USP, 25 mg

Purpose

Nighttime sleep-aid

Uses

■ for relief of occasional sleeplessness■ reduces time to fall asleep if you have difficulty falling asleep.

Do Not Use

■ for children under 12 years of age■ with any other product containing diphenhydramine, even one used on skin■ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask A Doctor Before Use If You Have

■ a breathing problem such as asthma, emphysema, or chronic bronchitis■ glaucoma■ difficulty in urination due to enlargement of the prostate gland■ heart disease

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers or any other sleep-aid

When Using This Product

■ avoid alcoholic beverages and other drugs that cause drowsiness■ drowsiness will occur■ be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take only one dose per day (24 hours) see Overdose warningadults & children 12 years and over2 gelcaps at bedtime if needed or as directed by a doctor

Other Information

■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.■ avoid high humidity

Inactive Ingredients

Ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum

* Please review the disclaimer below.

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