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Status:
US Previously Marketed
Source:
Narcotine by Merck
(1897)
Source URL:
First marketed in 1897
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Noscapine (also known as Narcotine, Nectodon, Nospen, Anarcotine and (archaic) Opiane) is a benzylisoquinoline alkaloid from plants of the poppy family, without painkilling properties. This agent is primarily used for its antitussive (cough-suppressing) effects. Noscapine is often used as an antitussive medication. A 2012 Dutch guideline, however, does not recommend its use for coughing. Noscapine can increase the effects of centrally sedating substances such as alcohol and hypnotics. Noscapine should not be taken in conjunction with warfarin as the anticoagulant effects of warfarin may be increased. Noscapine, and its synthetic derivatives called noscapinoids, are known to interact with microtubules and inhibit cancer cell proliferation. Mechanisms for its antitussive action are unknown, although animal studies have suggested central nervous system as a site of action. Furthermore, noscapine causes apoptosis in many cell types and has potent antitumor activity against solid murine lymphoid tumors (even when the drug was administered orally) and against human breast and bladder tumors implanted in nude mice. Because noscapine is water-soluble and absorbed after oral administration, its chemotherapeutic potential in human cancer merits thorough evaluation. Antifibrotic effect of noscapine based on novel mechanism, which it shows through EP2 prostaglandin E2 receptor-mediated activation of protein kinase A.
Status:
US Previously Marketed
Source:
Guaiacol
(1892)
Source URL:
First marketed in 1892
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Guaiacol is a naturally occurring organic compound first isolated by Otto Unverdorben in 1826. Although it is biosynthesized by a variety of organisms, this yellowish aromatic oil is usually derived from guaiacum or wood creosote. Guaiacol is used as a reducing co-substrate for COX reactions. It is mainly used as expectorant, antiseptic. It is used as cough suppressant, it is an ingredient of Pulmo Bailly (UK). Pulmo Bailly Cough Expectorant is indicated for relief for cough symptoms that are associated with a flu, cold, or other infection. It contains active ingredients, Codeine and Guajacol, which reduce discomfort and the urge to cough. Each 5 ml tablespoon of Pulmo Bailly contains 75 mg guaiacol and 7 mg codeine.
Status:
US Previously Marketed
First marketed in 1885
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Antipyrine is an analgesic and antipyretic that has been given by mouth and as ear drops. It is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. It inhibits cyclooxygenases and shows little anti-inflammatory activity. Like many old and approved substances after almost 100 years of use, antipyrine has been associated with some serious side effects, namely agranulocytosis and shock reactions.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(29) sunscreen glyceryl aminobenzoate (lisadimate, glyceryl PABA)
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Lisadimate (glyceryl PABA), a substituted aminobenzoate, is a sunscreen with actions similar to those of aminobenzoic acid. It is effective against UVB light. Glyceryl PABA (Escalol 106), present in many popular sunscreens, is a common sensitizer which invariably cross-reacts with benzocaine; it is present in over 400 over-the-counter products. Glyceryl PABA does not appear to cross-react with the sunscreening agents amyl (Escalol 506) and octyl (Escalol 507) dimethyl PABA. Glyceryl PABA, may, on occasion, cross-react with para-aminobenzoic acid (PABA), paraphenylenediamine, aniline, and sulfa drugs. Ironically, the sunscreening agent glyceryl PABA may, itself, act as a photosensitizing agent.
Status:
US Previously Marketed
Source:
64 FR 27682 sunscreen sodium 3, 4-dimethylphenyl-glyoxylate
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sodium 3,4-dimethylphenylglyoxylate is a topical analgesic, sunscreen ingredient, UV-B absorber, FDA approved.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(27)(viii) antimicrobial:personnel hand wash tribromsalan
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tribromsalan (trade name Temasept IV) is a member of brominated salicylanilides chemical family. Was initially registered in 1964 manufactured by Hexcel Corporation, Sherwin Williams Chemicals. It is a pesticide type with antimicrobial and preservative features found its application in hard surfaces, laundry, textiles, and manufactured products. Types of tribromsalan formulations include solid, solutions, and sprays and its usual carrier is soap. Limited exposure is possible based on the registered uses of these products as disinfectants, laundry additives, textile preservatives, and manufactured products and do not include direct application to a food or feed crop. In 1974 FDA directed the removal of tribromsalan drug products from the market because it was found to make skin extrasensitive to light. For the same reason it was forbidden in Europe since the 1970s. Since 1982 the OTC topical antimicrobial drug products rulemaking was reopened and included tribromsalan in a list of antimicrobial OTC Drug Products. At present tribromsalan is considered an antiseptic active ingredient eligible for the OTC use as a consumer antiseptic hand and body wash drug product. It was reported that tribromsalan, inhibits NF-kappaB signaling via inhibition of IkappaBalpha phosphorylation with IC50 of 7.9 uM. This finding provides new information on activities and mechanisms of action that may suggest mechanisms of potential novel applications in cancer treatment of such drugs as tribromsalan.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash dichlorophen
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Dichlorophene is a halogenated phenolic compound that functions as a bacteriocide and fungicide in cosmetics. Dichlorophene was reported to be used in a total of five cosmetic formulations at concentrations of 0% to 1.0%. Dichlorophen is used in the treatment of tapeworm infestation in man and animals and is the basis of a preparation against athlete’s foot. As a fungicide and bactericide it is recommended for the protection of textiles and materials including horticultural benches and equipment against moulds and algae.
Status:
Possibly Marketed Outside US
Source:
RUBINORM by Meltzer, H.L.|Fieve, R.R.
Source URL:
First approved in 2024
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Rubidium chloride is an inorganic compound with the formula RbCl. It appears to be nontoxic and therapeutically effective in several types of depressive disorders. This drug develops his action on dopaminergic stimulation reducing the depressive pattern. Also radioactive rubidium-82 chloride is used as diagnostic agent in positron emission tomography (PET).
Status:
Possibly Marketed Outside US
Source:
NCT02812043: Phase 4 Interventional Completed Non-dermatophyte Onychomycosis
(2016)
Source URL:
First approved in 2024
Source:
M005
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Amorolfine (or amorolfin), is a morpholine antifungal drug with broad spectrum of activity. Its fungicidal action is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. Amorolfine is administered as a nail lacquer in patients suffering from onychomycosis, as a cream in patients suffering from dermatomycosis. Amorolfine is well tolerated. The local adverse effects observed were mainly burning and itching.
Status:
Possibly Marketed Outside US
Source:
BSS Sterile Irrigating Solution
Source URL:
First approved in 2024
Source:
M018
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)