Drug Information |
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NDC Package Code
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83881-421-15
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The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
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Product NDC
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83881-421
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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.
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11 Digit NDC Code
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83881-0421-15
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It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
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Proprietary Name
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Salicor
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Also known as the trade name. It is the name of the product chosen by the labeler.
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Non Proprietary Name
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- Triethanolamine Salicylate
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Sometimes called the generic name, this is usually the active ingredient(s) of the product.
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Product Type Name
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HUMAN OTC DRUG
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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. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
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Labeler Name
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Clinic Pharma
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Name of Company corresponding to the labeler code segment of the ProductNDC.
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Status
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Deprecated
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Possible status values:
- Active
Active NDC Code
- Deprecated
Deprecated NDC Code
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Unfinished (Unapproved)
The following status describes submitted unfinished drugs,
including the marketing categories of Active Pharmaceutical Ingredient (API),
Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding.
FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
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Description
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Salicor is an external analgesic product containing 10% triethanolamine salicylate as the active ingredient. Triethanolamine salicylate is an organic compound formed between triethanolamine and salicylic acid, where triethanolamine neutralizes the acidity of salicylic acid. This external analgesic is designed for temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises. Unlike other external analgesics, triethanolamine salicylate has no distinct odor, which improves patient acceptability. Triethanolamine Salicylate 10% Rx only. Inactive ingredients: crospovodone, polyisobutylene rubber PSA adhesive.
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General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
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Indication And Usage
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Salicor is indicated for the temporary relief of minor aches and pains of muscles and joints associated with: arthritis, simple backache, muscle strains and sprains, bruises, bursitis, and dysmenorrhea. The patch provides a localized analgesic effect directly at the site of pain, offering convenience and sustained relief compared to cream formulations.
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A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.
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