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Status:
US Approved OTC
Source:
21 CFR 331.11(c)(1) antacid:bismuth-containing bismuth aluminate
Source URL:
First approved in 1961
Source:
ESTOMUL BISMUTH ALUMINATE by RIKER
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Bismuth aluminate is an antacid drug. The good therapeutic results are due to a coating effect providing a local antipepsin action at the site of the ulcer is an interesting possibility. Inorganic bismuth derivatives have good antibacterial properties and are considered to be only slightly toxic to humans because of their low uptake into human cells. The formation of methylated bismuth derivatives in the human gut may damage mammalian cells as well as the physiological gut microbiota.
Status:
US Approved OTC
Source:
21 CFR 341.18 cough/cold:expectorant guaifenesin
Source URL:
First approved in 1961
Source:
BRONKODYL GLYCERYL GUAIACOLATE by PRL
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions. Guaifenesin is over-the-counter drug for the treatment of cough and common cold.
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(5) ophthalmic:demulcents propylene glycol
Source URL:
First approved in 1961
Source:
VOSOL PROPYLENE GLYCOL by WAMPOLE LABS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
PROPYLENE GLYCOL is a component of SYSTANE® Lubricant. It is used for the temporary relief of burning and irritation due to dryness of the eye.
Status:
US Approved OTC
Source:
21 CFR 333.210(a) antifungal clioquinol
Source URL:
First approved in 1961
Source:
NYSTAFORM by BAYER PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Clioquinol is a broad-spectrum antibacterial with antifungal properties, bacteriostatic. It is used as an antifungal and antiprotozoal topical drug OTC product for treatment of human infections. Previousely was used for wide number of intestinal disorders including lambliasis, shigellosis, balantidiral dysentery and some forms of diarrheas. The physiologic effect of clioquinol is by increased histamine release and cell-mediated immunity. It is a member of a family hydroxyquinolines which inhibit certain enzymes related to DNA replication. It is a copper, iron and zink chelating agent. It is an organic molecule with a quinolinic acid as its apparent core which itself is a neurotransmitter. In large doses it possesses neurotoxicity and may induce neurological disease such as subacute myelo-optic neuropathy by creating copper deficiency that leads to zink excess. SMON (Sub-Acute-Myelo-Optical-Neuropathy) - a polio-like disease began as an epidemic in 1959 in Japan was believed to be a Clioquinol caused. Clioquinol is a standardized chemical allergen. It has been resurrected as a potential treatment for Alzheimer's disease since it perturbs metallo-chemistry of amyloid and clioquinol treatment has been shown to be beneficial in a mouse model of Alzheimer's disease.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal calcium undecylenate
Source URL:
First approved in 1961
Source:
CALDECORT OINTMENT CALCIUM UNDECYLENATE by PENNWALT
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Calcium Undecylenate is the calcium salt of undecylenic acid, an 11 carbon mono-unsaturated fatty acid with broad-spectrum antifungal activity. Undecylenic acid inhibits the morphogenesis of Candida albicans to its invasive fungal form and inhibits the conversion of unicellular yeast to their hyphal form.
Status:
US Approved OTC
Source:
21 CFR 341.20(a)(2) cough/cold:nasal decongestant pseudoephedrine hydrochloride
Source URL:
First approved in 1961
Source:
DISOPHROL by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Pseudoephedrine is a sympathomimetic drug. Pseudoephedrine acts as an adrenomimetic and inhibitor of monoamine transporters. Ephedra sinica, a species of ephedra (ma huang), contains ephedrine and pseudoephedrine. Ephedra has been found to stimulate the nervous system, increase airflow into the lungs and constrict blood vessels. In combination with caffeine, ephedra appears to cause weight loss. Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal copper undecylenate
Source URL:
First approved in 1961
Source:
DECUPRYL COPPER UNDECYLENATE by TILDEN YATES
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Copper undecylenate was used for the therapy of cutaneous dermatomycoses combined with a wetting agent and dissolved in a fat-solvent base. Undecylenic acid inhibits the morphogenesis of Candida albicans to its invasive fungal form and inhibits conversion of unicellular yeast to their hyphal form.
Status:
US Approved OTC
Source:
21 CFR 341.14(a)(1) cough/cold:antitussive chlophedianol hydrochloride
Source URL:
First approved in 1960
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Chlophedianol (Clofedanol) is a centrally-acting cough suppressant, although the mechanism of action is not known. It is available in Canada under the trade name Ulone. It is not available in the United States. Chlophedianol (Clofedanol) suppresses the cough reflex by a direct effect on the cough center in the medulla of the brain. It also has local anesthetic and antihistamine properties, and may have anticholinergic effects at high doses.
Status:
US Approved OTC
Source:
21 CFR 331.11(g)(1) antacid:magnesium-containing hydrate magnesium aluminate activated sulfate
Source URL:
First approved in 1960
Class (Stereo):
CHEMICAL (ACHIRAL)
Almagodrate anhydrous is an antacid.
Status:
US Approved OTC
Source:
21 CFR 341.20(b)(10) cough/cold:nasal decongestant xylometazoline hydrochloride
Source URL:
First approved in 1959
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Xylometazoline, also spelled xylomethazoline, is a medication which is used to improve symptoms of nasal congestion, allergic rhinitis, and sinusitis. Xylometazoline was patented in 1956 and came into medical use in 1959. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. The drug works by stimulating adrenergic receptors on the lamina propria of blood vessels in the nose. The decongestant effect is due to constriction of large veins in the nose which swell up during the inflammation of any infection or allergy of the nose. The smaller arteries are also constricted and this causes the colour of the nasal epithelium to be visibly paler after dosage. The standard adult solution strength is 0.1% w/v xylometazoline (or 1 mg per 1 mL solution), and the dose for children under 12 is usually 0.05% (0.5 mg/mL).