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Status:
US Approved OTC
Source:
21 CFR 341.16(g) cough/cold:bronchodilator racepinephrine hydrochloride
Source URL:
First approved in 2000
Source:
21 CFR 341
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Racepinephrine or racemic epinephrine is a mixture of levo and dextro isomers of epinephrine act as a nonselective agonist at adrenergic receptors. It is a bronchodilator used in the temporary relief of mild symptoms of intermittent asthma including wheezing, shortness of breath. Inhaled racepinephrine became available in September 2012 as a nonprescription treatment for bronchospasm based on a 1986 US Food and Drug Administration rule. Besides, racemic epinephrine relieves respiratory distress in hospitalized infants with bronchiolitis and is safe but does not abbreviate hospital stay. Morbidity associated with bronchiolitis as identified by parents persists for at least one week after hospital discharge in most infants.
Status:
US Approved OTC
Source:
21 CFR 358.610 pediculicide piperonyl butoxide
Source URL:
First approved in 2000
Source:
RID MOUSSE by BAYER HEALTHCARE LLC
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Piperonyl butoxide (PBO) is an organic compound used as a component of pesticide formulations. It is a waxy white solid. It is a semisynthetic derivative of safrole. It is used for the treatment of head, pubic (crab), and body lice. Piperonyl butoxide is a synergist. It has no pesticidal activity of its own, but acts to increase the activity of pesticides such as carbamates, pyrethrins, pyrethroids, and rotenone. PBO acts as an insecticide synergist by inhibiting the natural defense mechanisms of the insect, the most important of which is the Mixed Function Oxidase system, also known as the cytochrome P-450 system. The MFO system is the primary route of detoxification in insects, and causes the oxidative breakdown of insecticides like pyrethrins and the synthetic pyrethroids - thus when PBO is added, higher insecticide levels remain in the insect to exercise their lethal effect. An important consequence of this property is that, by enhancing the activity of a given insecticide, less may be used to achieve the same result. PBO does not appear to have a significant effect on the MFO system in humans. Skin Sensitization PBO has a low acute toxicity by oral, inhalation and dermal routes. It is minimally irritating to the eyes and skin. It is a not a dermal sensitizer. No evidence suggests that PBO disrupts the normal functioning of the endocrine system. This includes the recently developed data to assess the possible interaction of PBO with the endocrine system.
Status:
US Approved OTC
Source:
21 CFR 333.310(a) acne benzoyl peroxide
Source URL:
First approved in 1984
Source:
NDA050557
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation.
Status:
US Approved OTC
Source:
21 CFR 350.10(g) antiperspirant aluminum dichlorohydrex propylene glycol
Source URL:
First approved in 1979
Source:
21 CFR 350
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
US Approved OTC
Source:
21 CFR 333.210(g) antifungal clotrimazole
Source URL:
First approved in 1975
Source:
LOTRIMIN by SCHERING PLOUGH
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Clotrimazole is an anti-fungal medicine indicated for the treatment of vaginal yeast infections and tinea. It can be used either in combination with other drugs (betamethasone dipropionate) or alone, in form of topical or vaginal cream. The drug exerts its action by inhibiting lanosterol demethylase thereby affecting the growth of fungi.
Status:
US Approved OTC
Source:
21 CFR 333.210(c) antifungal miconazole nitrate
Source URL:
First approved in 1974
Source:
MONISTAT-DERM by INSIGHT PHARMS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Miconazole is a synthetic imidazole derivative, a topical antifungal agent for use in the local treatment of vaginal, and skin and nail infections due to yeasts and dermatophytes. It is particularly active against Candida spp., Trichophyton spp., Epidermophyton spp., Microsporum spp. and Pityrosporon orbiculare (Malassezia furfur), but also possesses some activity against Gram-positive bacteria. It binds to the heme moiety of the fungal cytochrome P-450 dependent enzyme lanosterol 14-alpha-demethlyase. Inhibits 14-alpha-demethlyase, blocks formation of ergosterol and leads to the buildup of toxic methylated 14-a-sterols. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of active oxygen species within the cell.
Status:
US Approved OTC
Source:
21 CFR 357.110 anthelmintic pyrantel pamoate
Source URL:
First approved in 1971
Class (Stereo):
CHEMICAL (ACHIRAL)
Pyrantel is an anthelmintic, which acts as an agonist of nicotinic receptors (AChRs) of nematodes and exerts its therapeutic effects by depolarizing their muscle membranes. It is used to treat a number of parasitic worm infections. This includes ascariasis, hookworm infections, enterobiasis (pinworm infection), trichostrongyliasis and trichinellosis. Common adverse reactions include diarrhea, nausea, vomiting, dizziness, headache and somnolence.
Status:
US Approved OTC
Source:
21 CFR 333.210(b) antifungal haloprogin
Source URL:
First approved in 1971
Source:
HALOTEX by WESTWOOD SQUIBB
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Haloprogin is an active synthetic antifungal and antimonilial agent that was effective in the treatment of superficial fungal and monilial infections of the skin. Because of these two basic therapeutic effects, haloprogin was especially useful in the treatment of infections when the identity of the specific causative organism had not been established or is being determined. Studies in-vitro demonstrated antifungal, antimonilial and antibacterial activity. It was shown to demonstrate marked in-vitro activity against Staphylococcus and Streptococcus. Haloprogin is no longer available in the US.
Status:
US Approved OTC
Source:
21 CFR 331.11(g)(3) antacid:magnesium-containing magnesium aluminosilicate
Source URL:
First approved in 1965
Source:
Silodrate by Mallinckrodt
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Magnesium aluminosilicate is an antacid, it is used in combination with magnesium hydroxide to relieve heartburn.
Status:
US Approved OTC
Source:
21 CFR 333.210(e) antifungal tolnaftate
Source URL:
First approved in 1965
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Tolnaftate is a thiocarbamate derivative used as an over-the-counter anti-fungal agent for treatment of athlete's foot and ringworm. Tolnaftate acts by inhibition of ergosterol biosynthesis pathway in fungal cells.