Diphenhydramine Hcl
Pd-rx Pharmaceuticals, Inc.
Human Otc Drug
NDC 55289-479Diphenhydramine Hcl is a human otc drug labeled by 'Pd-rx Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Diphenhydramine Hcl is 55289-479. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Diphenhydramine Hcl drug includes Diphenhydramine Hydrochloride - 25 mg/1 . The currest status of Diphenhydramine Hcl drug is Active.
Drug Information:
| Drug NDC: | 55289-479 |
| 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: | Diphenhydramine Hcl |
| 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 Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pd-rx Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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: | 11 Oct, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | part341 |
| 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: | PD-Rx Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049909
|
| 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. |
| 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 |
|---|
| 55289-479-10 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10) | 27 Mar, 2021 | N/A | No |
| 55289-479-12 | 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12) | 27 Mar, 2021 | N/A | No |
| 55289-479-15 | 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15) | 27 Mar, 2021 | N/A | No |
| 55289-479-20 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20) | 27 Mar, 2021 | N/A | No |
| 55289-479-24 | 24 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24) | 27 Mar, 2021 | N/A | No |
| 55289-479-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30) | 11 Jul, 2018 | 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 antihistamine
Product Elements:
Diphenhydramine hcl diphenhydramine hcl ferrosoferric oxide d&c red no. 28 fd&c blue no. 1 fd&c red no. 40 gelatin lactose monohydrate magnesium stearate silicon dioxide sodium lauryl sulfate diphenhydramine hydrochloride diphenhydramine pink (clear) , white (clear) , red (band) ph014
Indications and Usage:
Uses: temporarily relieves these symptoms associated with the common cold, hay fever, or other upper respiratory allergies: -sneezing -nasal congestion -runny nose -watery eyes -itchy, watery eyes
Warnings:
Warnings:
Do Not Use:
Warnings:
When Using:
When using this product avoid alcoholic drinks marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions: take every 4-6 hours, or as directed by a doctor do not exceed 6 times in 24 hours. adults and children 12 years and over 25 mg to 50 mg(1 to 2 capsules) children 6 to under 12 years of age 12.5 mg** to 25mg (1 capsule) children under 6 years of age ask a doctor ** 12.5 mg dosage strength is not avaliable in this bottle. do not attempt to break capsule.
How Supplied:
16. how supplied pink and white capsule with red band, imprinted with ph014, supplied as: bottles of 10 (ndc 55289-479-10) bottles of 12 (ndc 55289-479-12) bottles of 15 (ndc 55289-479-15) bottles of 20 (ndc 55289-479-20) bottles of 24 (ndc 55289-479-24) bottles of 30 (ndc 55289-479-30) storage store at room temperature 15°c to 30°c (59°f to 86°f)
Package Label Principal Display Panel:
Image
Further Questions:
Questions? adverse drug event call: (866)562-2756