NDC 66715-6643 Sleep-aid, Lil Drug Store

Diphenhydramine Hcl Caplet, 25mg

NDC Product Code 66715-6643

NDC CODE: 66715-6643

Proprietary Name: Sleep-aid, Lil Drug Store 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 Caplet, 25mg 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: OVAL (C48345)
Size(s):
14 MM
Imprint(s):
44;672
Score: 1

NDC Code Structure

  • 66715 - Lil' Drug Store Products, Inc.

NDC 66715-6643-8

Package Description: 2 BLISTER PACK in 1 CARTON > 12 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Sleep-aid, Lil Drug Store with NDC 66715-6643 is a a human over the counter drug product labeled by Lil' Drug Store Products, Inc.. The generic name of Sleep-aid, Lil Drug Store is diphenhydramine hcl caplet, 25mg. The product's dosage form is tablet, film coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1049630.

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, Lil Drug Store 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.

  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Lil' Drug Store Products, Inc.
Labeler Code: 66715
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: 12-20-2021 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: 12-31-2022 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.

Sleep-aid, Lil Drug Store 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

Active ingredient (in each caplet)Diphenhydramine HCl 25 mg

Purpose

PurposeNighttime sleep-aid

Uses

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

Warnings

​Warnings

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 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 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.

Directions

  • Directionsdo not take more than directedadults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctorchildren under 12 years: do not use

Other Information

  • ​Other informationeach caplet contains: calcium 65 mgavoid excessive heat (greater than 100°F) or humiditystore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients

Inactive ingredientscorn starch, D&C red #27 aluminum lake, dibasic calcium

phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions?

Questions? Call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)

Pdp [Lil' Drug Store Nighttime Sleep-Aid, 24Ct]

  • [caduceus]*Compare to the Active Ingredient in
  • VICKS® ZzzQuil
  • ®NighttimeSleep-Aid
  • Diphenhydramine HCI 25 mg
  • Nighttime Sleep-Aid
  • [caplet image]ACTUAL SIZENon-Habit Forming​Not for treating Pain, Cold or Flu
  • 24
  • Caplets
  • [Lil' Drug Store logo]

Pdp [Circle K Nighttime Sleep-Aid, 24Ct]

NON-HABIT FORMING

NOT FOR TREATING PAIN, COLD OR FLU

Compare to the active ingredient in
Vicks® ZzzQuil
®*
CIRCLE K™nighttime

sleep-aid

Diphenhydramine HCI, 25 mg

Nighttime Sleep-Aid
[caplet image]actual size24 caplets

* Please review the disclaimer below.