Children Allergy Relief Dye Free Cherry
Diphenhydramine Hcl
Strategic Sourcing Services Llc
Human Otc Drug
NDC 70677-0144Children Allergy Relief Dye Free Cherry also known as Diphenhydramine Hcl is a human otc drug labeled by 'Strategic Sourcing Services Llc'. National Drug Code (NDC) number for Children Allergy Relief Dye Free Cherry is 70677-0144. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Children Allergy Relief Dye Free Cherry drug includes Diphenhydramine Hydrochloride - 12.5 mg/5mL . The currest status of Children Allergy Relief Dye Free Cherry drug is Active.
Drug Information:
| Drug NDC: | 70677-0144 |
| 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: | Children Allergy Relief Dye Free Cherry |
| 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: | Strategic Sourcing Services Llc |
| 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 - 12.5 mg/5mL
|
| 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: | 22 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | Strategic Sourcing Services LLC
|
| 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 |
|---|
| 70677-0144-1 | 1 BOTTLE in 1 CARTON (70677-0144-1) / 118 mL in 1 BOTTLE | 16 May, 2022 | N/A | No |
| 70677-0144-2 | 1 BOTTLE in 1 CARTON (70677-0144-2) / 236 mL in 1 BOTTLE | 16 May, 2022 | 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:
Children allergy relief dye free cherry diphenhydramine hcl diphenhydramine hydrochloride diphenhydramine carboxymethylcellulose sodium anhydrous citric acid glycerin water sodium benzoate sorbitol saccharin sodium anhydrous
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Warnings:
Warnings .
Do Not Use:
Warnings .
When Using:
When using this product sedatives and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur, especially in children
Dosage and Administration:
Directions find right dose on chart below ml=milliliter measure only with dosing cup provided do not use dosing cup with other products take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours age(yr) dose(ml) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 ml to 10 ml
Package Label Principal Display Panel:
Principal display panel sunmark ® compare to children's benadryl ® oral solution active ingredient* ndc 70677-0144-1 children's allergy relief dye-free relieves: sneezing, runny nose, itchy, watery eyes & itching of the nose or throat 4-6 hours/dose antihistamine diphenhydramine hcl 12.5 mg/5 ml oral solution cherry flavor 4 fl oz(118 ml) 549-4
Further Questions:
Questions or comments? call 833-358-6431 monday to friday 9:00 am to 7:00 pm est