Adult Allergy Relief Dye Free
Diphenhydramine Hydrochloride
Walgreen Company
Human Otc Drug
NDC 0363-7100Adult Allergy Relief Dye Free also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Walgreen Company'. National Drug Code (NDC) number for Adult Allergy Relief Dye Free is 0363-7100. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Adult Allergy Relief Dye Free drug includes Diphenhydramine Hydrochloride - 25 mg/10mL . The currest status of Adult Allergy Relief Dye Free drug is Active.
Drug Information:
| Drug NDC: | 0363-7100 |
| 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: | Adult Allergy Relief Dye Free |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Adult Allergy Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Dye Free |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Walgreen Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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/10mL
|
| 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: | 30 Jan, 2020 |
| 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: | 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: | WALGREEN COMPANY
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049906
|
| 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. |
| 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 |
|---|
| 0363-7100-04 | 1 BOTTLE in 1 CARTON (0363-7100-04) / 118 mL in 1 BOTTLE | 30 Jan, 2020 | 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:
Adult allergy relief dye free diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine anhydrous citric acid carboxymethylcellulose sodium, unspecified cherry glycerin potassium citrate water sodium benzoate sorbitol sucralose colorless to pale yellow
Indications and Usage:
Uses ? temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ? sneezing ? itchy, watery eyes ? runny nose ? itching of the nose or throat
Warnings:
Warnings do not use ? to make a child sleepy ? with any other product containing diphenhydramine, even one used on skin
When Using:
When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children if pregnant or breast feeding, ask a health professional before use
Dosage and Administration:
Directions ? measure only with dosing cup provided ? keep dosing cup with product ? ml = milliliter ? do not take more than 6 doses in 24 hours age (yr) dose (ml) adult and children 12 years and older 10 ml to 20 ml (2 to 4 tsp) every 4 to 6 hrs children under 12 years do not use
Package Label Principal Display Panel:
Package label-principal display panel 4 fl oz (118 ml bottle) ndc 0363-7100-04 dye-free adult allergy relief diphenhydramine hcl | antihistamine for relief of: runny nose itchy, watery eyes sneezing and itchy watery eyes sugar free cherry flavor naturally and artificially flavored 4 fl oz (118 ml) our pharmacists recommend the walgreens brand. distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens 100% satisfaction guranteed walgreens.com @2021 walgreens co. important: keep this carton for future reference on full labeling. dye-free adult's allergy relief diphenydramine hcl