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Status:
US Approved OTC
Source:
21 CFR 355.10(b)(1) anticaries:dentifrices sodium monolfuorophosphate (gel or paste)
Source URL:
First approved in 1953
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Monofluorophosphate (MFP) is an anion, which is a phosphate group with one oxygen atom substituted with a fluorine atom. Sodium Monofluorophosphate is intended to be used by both petitioners in food supplements as a source of fluoride in the forms of multi-vitamin, multi-mineral supplements, solid tablets or tablets dispersible in liquid. The toxic effects of Monofluorophosphate are attributable to the fluoride ion released by the in vivo hydrolysis of the parent compound. The Monofluorophosphate ion appears to play no role. The acute toxicity of Monofluorophosphate is somewhat less than that of NaF, due to the lesser availability of fluoride in the short term from Monofluorophosphate. In the long term, Monofluorophosphate produces virtually the same picture of renal effects and skeletal storage of fluoride as does NaF. Sodium Monofluorophosphate dissociates into sodium and Monofluorophosphate ions in the intestinal tract, the latter being absorbed mainly in the upper small intestine.
Status:
US Approved OTC
Source:
21 CFR 333.110(f) first aid antibiotic:ointment tetracycline hydrochloride
Source URL:
First approved in 1953
Source:
ACHROMYCIN by LEDERLE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Discovered as natural products from actinomycetes soil bacteria, the tetracyclines were first reported in the scientific literature in 1948. They were noted for their broad spectrum antibacterial activity and were commercialized with clinical success beginning in the late 1940s to the early 1950s. By catalytic hydrogenation of Aureomycin, using palladium metal and hydrogen, the C7 deschloro derivative was synthesized, producing a compound of higher potency, a better solubility profile, and favorable pharmacological activity; it was subsequently named tetracycline. Tetracyclines are primarily bacteriostatic and exert their antimicrobial effect by the inhibition of protein synthesis by binding to the 30S ribosomal subunit. Tetracycline is active against a broad range of gram-negative and gram-positive organisms. Tetracycline is indicated in the treatment of infections caused by susceptible strains. To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline
hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by bacteria.
Status:
US Approved OTC
Source:
21 CFR 332.10 antiflatulent simethicone
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Silicon dioxide (silica) is most commonly found in nature as quartz, as well as in various living organisms. Silicon dioxide one of the most complex and most abundant families of materials, existing both as several minerals and being produced synthetically. In food and pharmaceutical industry silica is a common additive, where it is used primarily as a flow in powdered foods, or to adsorb water in hygroscopic application. In pharmaceutical products, silica aids powder flow when tablets are formed.
Status:
US Approved OTC
Source:
21 CFR 332.10 antiflatulent simethicone
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Silicon dioxide (silica) is most commonly found in nature as quartz, as well as in various living organisms. Silicon dioxide one of the most complex and most abundant families of materials, existing both as several minerals and being produced synthetically. In food and pharmaceutical industry silica is a common additive, where it is used primarily as a flow in powdered foods, or to adsorb water in hygroscopic application. In pharmaceutical products, silica aids powder flow when tablets are formed.
Status:
US Approved OTC
Source:
21 CFR 332.10 antiflatulent simethicone
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Silicon dioxide (silica) is most commonly found in nature as quartz, as well as in various living organisms. Silicon dioxide one of the most complex and most abundant families of materials, existing both as several minerals and being produced synthetically. In food and pharmaceutical industry silica is a common additive, where it is used primarily as a flow in powdered foods, or to adsorb water in hygroscopic application. In pharmaceutical products, silica aids powder flow when tablets are formed.
Status:
US Approved OTC
Source:
21 CFR 358.710(a)(6) dandruff:dandruff selenium sulfide, micronized
Source URL:
First approved in 1951
Source:
SELSUN by CHATTEM
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Selenium sulfide, an anti-infective agent, relieves itching and flaking of the scalp and removes the dry, scaly particles that are commonly referred to as dandruff or seborrhea. It is also used to treat tinea versicolor, a fungal infection of the skin. Topical selenium sulfide can be added to the therapeutic armamentarium for congenital or acquired hyperkeratosis.
Status:
US Approved OTC
Source:
21 CFR 357.810(b) deodorants for internal use chlorophyllin copper complex
Source URL:
First approved in 1950
Class (Stereo):
CHEMICAL (ABSOLUTE)
Chlorophyllin is a water soluble derivative of chlorophyll. It has chemopreventive properties and forms a non-covalent complex with many mutagenic/carcinogenic molecules. Chlorophyllin inhibits cancer initiation and progression by targeting multiple molecules and pathways involved in the metabolism of carcinogens, cell cycle progression, apoptosis evasion, invasion, and angiogenesis. The modulatory effects of Chlorophyllin to be mediated via abrogation of key oncogenic signal transduction pathways such as nuclear factor kappa B, Wnt/β-catenin, and phosphatidylinositol-3-kinase/Akt signaling. Chlorophyllin sodium copper salt mitigates radiation-induced hematopoietic syndrome by increasing the abundance of hematopoietic stem cells, enhancing granulopoiesis, and stimulating prosurvival pathways in bone marrow cells and lymphocytes. In addition, chlorophyllin exhibits antioxidant, antiapoptotic and immunostimulatory effects. Chlorophyllin is intended to improve the quality of life in people who have fecal incontinence due to spinal cord injury, bowel cancer, psychotic disorder, terminal illness, or other disorders. Chlorophyllin is also used by people who have had a colostomy or ileostomy
Status:
US Approved OTC
Source:
21 CFR 333.120 first aid antibiotic:ointment oxytetracycline hydrochloride (combination only)
Source URL:
First approved in 1950
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Oxytetracycline, a tetracycline analog isolated from the actinomycete streptomyces rimosus, was the second of the broad-spectrum tetracycline group of antibiotics to be discovered The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms for animal use only. These infections include the following: Ocular infections due to streptococci, rickettsiae E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in dogs); ocular infections due to secondary bacterial complications associated with distemper in dogs; and ocular infections due to bacterial inflammatory conditions which may occur secondary to other diseases in dogs. Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken. Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.
Status:
US Approved OTC
Source:
21 CFR 341.12(c) cough/cold:antihistamine chlorpheniramine maleate
Source URL:
First approved in 1949
Source:
CHLOR-TRIMETON by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Chlorpheniramine is an antihistamine. Chlorpheniramine binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Chlorpheniramine is used for relieving symptoms of sinus congestion, sinus pressure, runny nose, watery eyes, itching of the nose and throat, and sneezing due to upper respiratory infections (eg, colds), allergies, and hay fever. In addition to being a histamine H1 receptor (HRH1) antagonist, chlorphenamine has been shown to work as a serotonin-norepinephrine reuptake inhibitor or SNRI.
Status:
US Approved OTC
Source:
21 CFR 341.20(b)(9) cough/cold:nasal decongestant propylhexedrine
Source URL:
First approved in 1949
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Propylhexedrine is considered to be an agonist of alpha-adrenergic receptors. It is effective as a topical vasoconstrictor. The primary medicinal use of Benzedrex (Propylhexedrine inhaler) propylhexedrine is temporary symptomatic relief of nasal decongestion due to colds, allergies and allergic rhinitis. Structurally and pharmacologically related to amphetamine.Exact mechanism of action unknown but thought to be similar to amphetamine. When used as a nasal inhaler for this indication, propylhexedrine reduces nasal airway resistance without producing rebound congestion. Abuse does not occur by nasal inhalation; however, a small amount of abuse of the propylhexedrine containing nasal inhalers occurs by oral ingestion of the contents of the inhaler or by intravenous injection. Propylhexedrine is a central nervous system (CNS) stimulant of low abuse potential, a stimulant of low preference for stimulant abusers compared with amphetamine, methylphenidate, phenmetrazine.