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Status:
US Approved OTC
Source:
21 CFR 341.20(b)(7) cough/cold:nasal decongestant oxymetazoline hydrochloride
Source URL:
First approved in 1964
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Oxymetazoline is an adrenergic alpha-agonist, direct acting sympathomimetic, used as a vasoconstrictor to relieve nasal congestion The sympathomimetic action of oxymetazoline constricts the smaller arterioles of the nasal passages, producing a prolonged (up to 12 hours), gentle and decongesting effect. Oxymetazoline elicits relief of conjunctival hyperemia by causing vasoconstriction of superficial conjunctival blood vessels. The drug's action has been demonstrated in acute allergic conjunctivitis and in chemical (chloride) conjunctivitis. Oxymetazoline is self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Oxymetazoline is available over-the-counter as a topical decongestant in the form of oxymetazoline hydrochloride in nasal sprays such as Afrin, Operil, Dristan, Dimetapp, oxyspray, Facimin, Nasivin, Nostrilla, Sudafed OM, Vicks Sinex, Zicam, SinuFrin, and Mucinex Full Force. Due to its vasoconstricting properties, oxymetazoline is also used to treat nose bleeds and eye redness.
Status:
US Approved OTC
Source:
21 CFR 350.10(o) antiperspirant aluminum zirconium tetrachlorohydrate
Source URL:
First approved in 1963
Class (Stereo):
CHEMICAL (ACHIRAL)
Zirconium Fluoride is a water insoluble Zirconium source for use in oxygen-sensitive applications, such as metal production. Zirconium fluoride in a mixture with other fluorides is a coolant for molten salt reactors. In the mixture with sodium fluoride it is a candidate coolant for the Advanced High-Temperature Reactor.
Status:
US Approved OTC
Source:
21 CFR 341.16(f) cough/cold:bronchodilator racephedrine hydrochloride
Source URL:
First approved in 1961
Source:
CHOLARACE RACEPHEDRINE HYDROCHLORIDE by WC
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Racephedrine in combination with theophylline, phenobarbital was used to treat bronchial asthma. However, its application was substituted more effective agent. In addition, FDA has reviewed the final monograph for over-the-counter bronchodilator drug products to add additional warnings and to revise the indications in the labeling of products containing racephedrine hydrochloride.
Status:
US Approved OTC
Source:
21 CFR 346.20(a) anorectal:keratolytic alcloxa
Source URL:
First approved in 1961
Source:
ALLANTOMIDE ALLANTOIN by NATIONAL DRUG
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Aldioxa is the generic name for the metal complex, dihydroxyaluminum allantoinate, which is hydrolyzed to allantoin and aluminium hydrate at the gastric mucosa. Aldioxa was approved in Japan to improve subjective symptoms or objective of gastric/duodenal ulcer and gastritis. It was discovered, that aldioxa ameliorates delayed gastric emptying through its antagonistic activity on the α-2 adrenergic receptor. The most commonly reported adverse reactions include constipation.
Status:
US Approved OTC
Source:
21 CFR 358.710(a)(2) dandruff:dandruff (wash-off) pyrithione zinc
Source URL:
First approved in 1961
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Pyrithione zinc is an antibacterial and antifungal agent developed by scientists in the 1930's. Since then it has been used to treat seborrheic dermatitis of the scalp and other skin conditions such as eczema, athlete's foot, and vitiligo, as well as psoriasis. Because of its antifungal properties, it is commonly found in dandruff shampoo. Products containing pyrithione zinc are available today with and without prescription, and it is the main ingredient in many over-the-counter creams, lotions, soaps, and shampoos. It also has antibacterial properties and is effective against many pathogens from the Streptococcus and Staphylococcus genera. Pyrithione zinc`s other medical applications include treatments of psoriasis, eczema, ringworm, fungus, athletes foot, dry skin, atopic dermatitis, tinea, and vitiligo. Its antifungal effect is thought to derive from its ability to disrupt membrane transport by blocking the proton pump that energizes the transport mechanism.
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.