NDC 76168-015 Sleep Aid
Diphenhydramine Hydrochloride
NDC Product Code 76168-015
Proprietary Name: 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 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):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
DB
Score: 1
NDC Code Structure
- 76168 - Velocity Pharma Llc
- 76168-015 - Sleep Aid
NDC 76168-015-07
Package Description: 1 BOTTLE in 1 CARTON > 36 TABLET, FILM COATED in 1 BOTTLE
NDC 76168-015-12
Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE
NDC Product Information
Sleep Aid with NDC 76168-015 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Sleep Aid is diphenhydramine hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form.
Labeler Name: Velocity Pharma Llc
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.
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.
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.
- CARNAUBA WAX (UNII: R12CBM0EIZ)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- ALUMINUM OXIDE (UNII: LMI26O6933)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- 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: Velocity Pharma Llc
Labeler Code: 76168
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: 05-14-2018 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 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.
Sleep Aid Product Label Images
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
- Active Ingredient (In Each Caplet)
- Purpose
- Use
- Do Not Use
- Ask A Doctor Before Use If You Have
- Otc - Ask Doctor/Pharmacist
- When Using This Product
- Stop Use And Ask A Doctor If
- Otc - Pregnancy Or Breast Feeding
- Otc - Keep Out Of Reach Of Children
- Overdose Warning
- Directions
- Other Information
- Inactive Ingredients
Other
Drug Facts
Active Ingredient (In Each Caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep aid
Use
For relief of occasional sleeplessness
Do Not Use
- In 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 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
When Using This Product
- Avoid alcoholic drinksdrowsiness will occurdo not drive a motor vehicle or operate 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.
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.
Overdose Warning
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 and overtake 2 caplets at bedtime if needed, or as directed by a doctorchildren under 12 yearsdo not use
Other Information
- Each caplet contains:
- Calcium 15 mgstore between 20-25
- °C (68-77
- °F). Avoid high humidity. Protect from light.
- Do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Inactive Ingredients
Carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
* Please review the disclaimer below.