Benzoicum Ac
Benzoic Acid
Washington Homeopathic Products
Human Otc Drug
NDC 68428-254Benzoicum Ac also known as Benzoic Acid is a human otc drug labeled by 'Washington Homeopathic Products'. National Drug Code (NDC) number for Benzoicum Ac is 68428-254. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Benzoicum Ac drug includes Benzoic Acid - 30 [hp_C]/1 . The currest status of Benzoicum Ac drug is Active.
Drug Information:
| Drug NDC: | 68428-254 |
| 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: | Benzoicum Ac |
| 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: | Benzoic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Washington Homeopathic Products |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pellet |
| 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: | BENZOIC ACID - 30 [hp_C]/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: | UNAPPROVED HOMEOPATHIC |
| 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: | 29 Apr, 2010 |
| 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. |
| 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: | Washington Homeopathic Products
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0740640248621
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175806
N0000175807
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 8SKN0B0MIM
|
| 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 MOA: | Ammonium Ion Binding Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nitrogen Binding Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Ammonium Ion Binding Activity [MoA]
Nitrogen Binding Agent [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 |
|---|
| 68428-254-03 | 75 PELLET in 1 VIAL, GLASS (68428-254-03) | 29 Apr, 2010 | N/A | No |
| 68428-254-05 | 150 PELLET in 1 VIAL, GLASS (68428-254-05) | 29 Apr, 2010 | N/A | No |
| 68428-254-06 | 1200 PELLET in 1 BOTTLE, GLASS (68428-254-06) | 29 Apr, 2010 | N/A | No |
| 68428-254-11 | 300 PELLET in 1 BOTTLE, GLASS (68428-254-11) | 29 Apr, 2010 | N/A | No |
| 68428-254-12 | 600 PELLET in 1 BOTTLE, GLASS (68428-254-12) | 29 Apr, 2010 | 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:
Uses to relieve the symptoms of bedwetting.
Product Elements:
Benzoicum ac benzoic acid sucrose lactose benzoic acid benzoic acid white
Indications and Usage:
Indications indications: benzoicum ac bedwetting
Warnings:
Stop use and ask doctor if symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.
Dosage and Administration:
Directions adults: dissolve 3 to 5 under the tongue three times a day or as directed by lic. practitioner. take at greater intervals as condition subsides. children: dissolve 3 to 5 under the tongue three times a day or as directed by lic. practitioner. take at greater intervals as condition subsides.
Package Label Principal Display Panel:
Principal display panel the otc potency range of product is 2xâ30x, 1câ30c, 200c, 1m, 10m, 50m, and cm. availability is subject to change. all whp single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled. âbottle sizeâ and âpotencyâ vary on the label depending on customer choice. standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce. label