Topcare Zzz Sleep
Diphenhydramine Hcl
Topco Associates Llc
Human Otc Drug
NDC 36800-200Topcare Zzz Sleep also known as Diphenhydramine Hcl is a human otc drug labeled by 'Topco Associates Llc'. National Drug Code (NDC) number for Topcare Zzz Sleep is 36800-200. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Topcare Zzz Sleep drug includes Diphenhydramine Hydrochloride - 50 mg/30mL . The currest status of Topcare Zzz Sleep drug is Active.
Drug Information:
| Drug NDC: | 36800-200 |
| 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: | Topcare Zzz Sleep |
| 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: | Topco Associates 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 - 50 mg/30mL
|
| 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: | 20 Aug, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | 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, 2024 |
| 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: | Topco Associates LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1248354
1437306
|
| 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 |
|---|
| 36800-200-30 | 177 mL in 1 BOTTLE (36800-200-30) | 23 Aug, 2013 | N/A | No |
| 36800-200-40 | 355 mL in 1 BOTTLE (36800-200-40) | 20 Aug, 2013 | N/A | No |
| 36800-200-50 | 2 BOTTLE in 1 PACKAGE (36800-200-50) / 355 mL in 1 BOTTLE | 20 Aug, 2013 | 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:
Topcare zzz sleep diphenhydramine hcl diphenhydramine hydrochloride diphenhydramine alcohol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 high fructose corn syrup poloxamer 407 propylene glycol water saccharin sodium sodium benzoate sodium citrate, unspecified form
Indications and Usage:
Uses ⢠for the relief of occasional sleeplessness ⢠reduces time to fall asleep if you have difficulty falling asleep
Warnings:
Warnings do not use ⢠for children under 12 years of age ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ⢠avoid alcoholic beverages 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 (1-800-222-1222).
Do Not Use:
Warnings do not use ⢠for children under 12 years of age ⢠with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product ⢠avoid alcoholic beverages 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 (1-800-222-1222).
When Using:
When using this product ⢠avoid alcoholic beverages
Dosage and Administration:
Directions ⢠take only one dose per day (24 hours) ⢠only use the dose cup provided adults & children 12 yrs & over 30 ml at bed time if needed or as directed by a doctor children under 12 yrs 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:
Package/label principal display panel topcare ® health nighttime compare to vicks ® zzzquil ® active ingredient zzz sleep ® diphenhydramine hcl 50 mg per 30 ml nighttime sleep-aid ⢠non-habit forming ⢠not for treating cold or flu alcohol 10% 6 fl oz (177 ml) berry flavor zzz sleep image
Further Questions:
Questions or comments? 1-888-423-0139