NDC 69721-005 Somnapure Clinical Strength

Diphenhydramine Hydrochloride

NDC Product Code 69721-005

NDC 69721-005-30

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, COATED in 1 BOTTLE

NDC Product Information

Somnapure Clinical Strength with NDC 69721-005 is a a human over the counter drug product labeled by Force Factor Brands Llc. The generic name of Somnapure Clinical Strength is diphenhydramine hydrochloride. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Force Factor Brands Llc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Somnapure Clinical Strength 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

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: Force Factor Brands Llc
Labeler Code: 69721
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: 03-20-2018 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: 12-31-2021 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.

Somnapure Clinical Strength Product Label Images

Somnapure Clinical Strength 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

Drug Facts

Active ingredient (in each caplet)Diphenhydramine HCl 50 mg

Otc - Purpose

PurposeNighttime sleep aid

Indications & Usage

Use helps to reduce difficulty in falling asleep

Warnings

Warnings

Otc - Do Not Use

  • Do not usein 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 have a breathing problem such as emphysema or chronic bronchitisglaucomadifficulty in urination due to enlargement of the 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 continuously for more than 2 weeks.  Insomnia may be a symptom of a serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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 (1-800-222-1222)  right away.

Dosage & Administration

  • Directionsadults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctorChildren under 12 years: do not use.

Other Safety Information

  • Other information each caplet contains: calcium 50 mgstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number.protect from moisture

Inactive Ingredient

Inactive ingredients  croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide

Otc - Questions

Questions of comments?  Call 1-855-606-6507

* Please review the disclaimer below.