Rest Simply
Diphenhydramine Hydrochloride
Harris Teeter
Human Otc Drug
NDC 72036-091Rest Simply also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Harris Teeter'. National Drug Code (NDC) number for Rest Simply is 72036-091. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Rest Simply drug includes Diphenhydramine Hydrochloride - 25 mg/1 . The currest status of Rest Simply drug is Active.
Drug Information:
| Drug NDC: | 72036-091 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Rest Simply |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Diphenhydramine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Harris Teeter |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIPHENHYDRAMINE HYDROCHLORIDE - 25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 06 Oct, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part338 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Harris Teeter
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049630
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0072036987150
|
| UPC stands for Universal Product Code. |
| UNII: | TC2D6JAD40
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 72036-091-01 | 2 BLISTER PACK in 1 CARTON (72036-091-01) / 12 TABLET, COATED in 1 BLISTER PACK | 06 Oct, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose nighttime sleep-aid
Product Elements:
Rest simply diphenhydramine hydrochloride silicon dioxide croscarmellose sodium calcium phosphate, dibasic, anhydrous fd&c blue no. 1 hypromellose, unspecified magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified polysorbate 80 titanium dioxide diphenhydramine hydrochloride diphenhydramine 25;052
Indications and Usage:
Use for relief of occasional sleeplessness
Warnings:
Warnings do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product avoid alcoholic drinks 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. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product avoid alcoholic drinks 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. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product avoid alcoholic drinks
Dosage and Administration:
Directions adults and children 12 years of age and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years of age do not use
Stop Use:
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.
Package Label Principal Display Panel:
Principal display panel harris teeter rest simply compare to the active ingredient in simply sleep(r) diphenhydramine hcl, 25 mg nighttime sleep-aid fall asleep fast, wake up refreshed safe and non-habit forming contains no pain reliever 24 caplets image description