Diphenhydramine Hcl Oral Solution
Diphenhydramine Hydrochloride
Dash Pharmaceuticals Llc
Human Otc Drug
NDC 69339-152Diphenhydramine Hcl Oral Solution also known as Diphenhydramine Hydrochloride is a human otc drug labeled by 'Dash Pharmaceuticals Llc'. National Drug Code (NDC) number for Diphenhydramine Hcl Oral Solution is 69339-152. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Diphenhydramine Hcl Oral Solution drug includes Diphenhydramine Hydrochloride - 25 mg/10mL . The currest status of Diphenhydramine Hcl Oral Solution drug is Active.
Drug Information:
| Drug NDC: | 69339-152 |
| 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 Oral Solution |
| 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: | Dash Pharmaceuticals 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 - 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: | 14 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | Dash Pharmaceuticals 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. |
| UPC: | 0369339151051
0369339152010
|
| 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 |
|---|
| 69339-152-17 | 4 TRAY in 1 CASE (69339-152-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01) | 14 Dec, 2020 | N/A | No |
| 69339-152-19 | 10 TRAY in 1 CASE (69339-152-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01) | 14 Dec, 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:
Diphenhydramine hcl oral solution diphenhydramine hydrochloride anhydrous citric acid glycerin water sucrose sodium benzoate sodium citrate, unspecified form d&c red no. 33 fd&c red no. 40 poloxamer 407 sodium chloride diphenhydramine hydrochloride diphenhydramine diphenhydramine hcl oral solution diphenhydramine hydrochloride anhydrous citric acid glycerin water sucrose sodium benzoate sodium citrate, unspecified form d&c red no. 33 fd&c red no. 40 poloxamer 407 sodium chloride diphenhydramine hydrochloride diphenhydramine
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠runny nose ⢠sneezing ⢠itchy, watery eyes ⢠itchy throat
Warnings:
Warnings do not use ⢠in neonates or premature infants ⢠if pregnant or breast-feeding ⢠if hypersensitive to diphenhydramine hci and other similar antihistamine ⢠with any other product containing diphenhydramine, even one used on skin ⢠to make a child sleepy ask a doctor before use if you have ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠a sodium restricted diet ⢠trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives 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 keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222)
Do Not Use:
Warnings do not use ⢠in neonates or premature infants ⢠if pregnant or breast-feeding ⢠if hypersensitive to diphenhydramine hci and other similar antihistamine ⢠with any other product containing diphenhydramine, even one used on skin ⢠to make a child sleepy ask a doctor before use if you have ⢠glaucoma ⢠a breathing problem such as emphysema or chronic bronchitis ⢠a sodium restricted diet ⢠trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives 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 keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222)
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
Dosage and Administration:
Directions ⢠use the following dosage guidelines when using this product age (yr) dose (ml) adults and children 12 years and older take 10 ml every 4 to 6 hours; not more than 60 ml in 24 hours. children 6 years to under 12 years take 5 ml every 4 to 6 hours; not more than 30 ml in 24 hours children under 6 years ask a doctor
How Supplied:
How supplied each 5 ml of diphenhydramine hydrochloride oral solution, usp contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: ndc 69339-151-05 (1) unit dose cup 5ml ndc 69339-151-17 40 (4x10) unit dose cups 5ml ndc 69339-151-19 100 (10x10) unit dose cups 5ml each 10 ml of diphenhydramine hydrochloride oral solution, usp contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: ndc 69339-152-01 (1) unit dose cup 10ml ndc 69339-152-17 40 (4x10) unit dose cups 10ml ndc 69339-152-19 100 (10x10) unit dose cups 10ml
Package Label Principal Display Panel:
Principal display panel delivers 5 ml ndc 69339-151-05 diphenydramine hcl oral solution, usp 12.5 mg/5 ml for institutional use only 3 69339 15105 1 lot # 000000 exp: mm/yyy see insert dash pharmaceuticals llc upper saddle river, nj 07458 dash- dose principal display panel
Principal display panel delivers 10 ml ndc 69339-152-01 diphenydramine hcl oral solution, usp 25 mg/10 ml for institutional use only 3 69339 15201 0 lot # 000000 exp: mm/yyy see insert dash pharmaceuticals llc upper saddle river, nj 07458 dash- dose principal display panel
Further Questions:
Questions or comments? call 201-786-6500 dash pharmaceuticals llc upper saddle river, nj 07458 dp-ud-pi-at-[117894] rev 08/20