{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Search results for "PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE" in comments (approximate match)
Status:
US Previously Marketed
Source:
Stearic Acid U.S.P.
(1921)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Stearic Acid is a typical example of a fatty acid, which are essentially long hydrocarbon chains containing a carboxyl group at one end and a methyl group at the other. The chain lengths can vary from 3 (propionic acid) to 24 (lignoceric acid) but the majority of fatty acids found in hydrogenated vegetable or animal oils are around C16-C20 in length. Stearic acid is a saturated acid, since there are no double bonds between neighbouring carbon atoms. Stearic acid is found in various animal and plant fats, and is a major component of cocoa butter and shea butter. Stearic acid is a very common amino acid is used in the manufacturing of more than 3,200 skin and hair care products sold in the United States. On product labels, it is sometimes listed under other names, including Century 1240, cetylacetic acid, Emersol 120, Emersol 132, Emersol 150, Formula 300 and Glycon DP. Stearic Acid is mainly used in the production of detergents, soaps, and cosmetics such as shampoos and shaving cream products. Stearic acid is used along with castor oil for preparing softeners in textile sizing. Being inexpensively available and chemically benign, stearic acid finds many niche applications It is used in the manufacture of candles, and as a hardener in candies when mixed with simple sugar and corn syrup. It is also used to produce dietary supplements. In fireworks, stearic acid is often used to coat metal powders such as aluminum and iron. This prevents oxidation, allowing compositions to be stored for a longer period of time.
Stearic acid is a common lubricant during injection molding and pressing of ceramic powders. It is also used as a mold release for foam latex that is baked in stone molds. Stearic acid is known antidiabetic and antioxidant agent.
Status:
US Previously Marketed
Source:
Sodium Hypophosphite U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Sodium Hypophosphite U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Hypophosphite is a strong reducing agent, that has been used in the 1850s as a remedy for pulmonary tuberculosis. Hypophosphites were used extensively in pharmaceutical preparations, elixirs, and tonics. Hypophosphite does not appear to have adverse toxicological effects, and the sodium, calcium, and potassium salts are considered GRAS. Hypophosphite use in foods may not be limited to one function. Hypophosphites have been used in foods as antioxidants, stabilizers, meat pickling accelerator, and vegetable protein flow inducer.
Status:
Possibly Marketed Outside US
Source:
Disinfectant(NaClO) by Shanghai Rayshine ENVI-TECH Developing CO., Ltd.
(2020)
Source URL:
First approved in 2020
Source:
Disinfectant(NaClO) by Shanghai Rayshine ENVI-TECH Developing CO., Ltd.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NDA207202
(2002)
Source URL:
First approved in 2002
Source:
NDA207202
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Cuprous Sulfide (Cu2S) occurs in nature as the mineral and has very different two-dimensional lattice structures, along with excellent electro-catalysis and high conductivity. Recently published article has shown that nanocomposites incorporated with Cu2S nanoflowers can be used for skin tumor therapy and wound healing.
Status:
Possibly Marketed Outside US
First approved in 1982
Source:
NDA018467
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Readily soluble in water, SnF2 is hydrolysed. At low concentration, it forms species such as SnOH+, Sn(OH)2 and Sn(OH)3−. At higher concentrations, predominantly polynuclear species are formed, including Sn2(OH)22+ and Sn3(OH)42+. Aqueous solutions readily oxidise to form insoluble precipitates of SnIV, which are ineffective as a dental prophylactic. Tin(II) fluoride, commonly referred to commercially (with tin(II) in Latin) as stannous fluoride, is a chemical compound with the formula SnF2. It is a colorless solid used as an ingredient in toothpastes that are typically more expensive than those that use sodium fluoride. Stannous fluoride has both bactericidal and bacteriostatic properties, which fight plaque and treat/prevent gingivitis. The stannous fluoride also deposits a protective mineral barrier over exposed dentinal tubules to help prevent sensitivity pain from triggers such as hot or cold liquids and foods. Stannous fluoride is used under the trade name "Fluoristan" in the original formulation of the toothpaste Crest, though it was later replaced with sodium monofluorophosphate, or "Fluoristat". It is the active ingredient in Crest Pro Health brand toothpaste. Crest Pro Health issues a warning on the tube that stannous fluoride may cause staining, which can be avoided by proper brushing, and that its particular formulation is resistant to staining. Any stannous fluoride staining that occurs due to improper brushing is not permanent. Stannous fluoride is also used in Oral-B Pro-Expert. Stannous fluoride is also readily available in over-the-counter rinses.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2013)
Source URL:
First approved in 1980
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
The iodate ion is an oxoanion of iodine bearing a negative charge and containing three oxygen atoms. Because it is more stable than iodide, most health authorities preferentially recommend iodate as an additive to salt for correcting iodine deficiency. In humans and rats, oral bioavailability of iodine from iodate is virtually equivalent to that from iodide. When given intravenously to rats, or when added to whole blood or tissue homogenates in vitro or to foodstuff, iodate is quantitatively reduced to iodide by nonenzymatic reactions, and thus becomes available to the body as iodide. Therefore, except perhaps for the gastrointestinal mucosa, exposure of tissues to iodate might be minimal. At much higher doses given intravenously (i.e., above 10 mg/kg), iodate is highly toxic to the retina. Ocular toxicity in humans has occurred only after exposure to doses of 600 to 1,200 mg per individual. Oral exposures of several animal species to high doses, exceeding the human intake from fortified salt by orders of magnitude, pointed to corrosive effects in the gastrointestinal tract, hemolysis, nephrotoxicity, and hepatic injury.
Status:
US Approved Rx
(2020)
Source:
NDA209376
(2020)
Source URL:
First marketed in 1921
Source:
Syrup of Iron and Manganese Iodide N.F.
Source URL:
Class:
MIXTURE
Conditions:
Manganese Bromide is a highly water soluble crystalline salt composed of manganese and bromine with the formula MnBr2. Manganese Bromide can be used in place of palladium in the Stille reaction, which couples two carbon atoms using an organotin compound
Status:
US Approved Rx
(2001)
Source:
NDA021265
(2001)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Cholecalciferol (/ˌkoʊləkælˈsɪfərɒl/) (vitamin D3) is one of the five forms of vitamin D. Cholecalciferol is a steroid hormone that has long been known for its important role in regulating body levels of calcium and phosphorus, in mineralization of bone, and for the assimilation of Vitamin A. The classical manifestation of vitamin D deficiency is rickets, which is seen in children and results in bony deformities including bowed long bones. Most people meet at least some of their vitamin D needs through exposure to sunlight. Ultraviolet (UV) B radiation with a wavelength of 290–320 nanometers penetrates uncovered skin and converts cutaneous 7-dehydrocholesterol to previtamin D3, which in turn becomes vitamin D3. In supplements and fortified foods, vitamin D is available in two forms, D2 (ergocalciferol) and D3 (cholecalciferol) that differ chemically only in their side-chain structure. Vitamin D2 is manufactured by the UV irradiation of ergosterol in yeast, and vitamin D3 is manufactured by the irradiation of 7-dehydrocholesterol from lanolin and the chemical conversion of cholesterol. The two forms have traditionally been regarded as equivalent based on their ability to cure rickets and, indeed, most steps involved in the metabolism and actions of vitamin D2 and vitamin D3 are identical. Both forms (as well as vitamin D in foods and from cutaneous synthesis) effectively raise serum 25(OH) D levels. Firm conclusions about any different effects of these two forms of vitamin D cannot be drawn. However, it appears that at nutritional doses, vitamins D2 and D3 are equivalent, but at high doses, vitamin D2 is less potent. The American Academy of Pediatrics (AAP) recommends that exclusively and partially breastfed infants receive supplements of 400 IU/day of vitamin D shortly after birth and continue to receive these supplements until they are weaned and consume ≥1,000 mL/day of vitamin D-fortified formula or whole milk. Cholecalciferol is used in diet supplementary to treat Vitamin D Deficiency. Cholecalciferol is inactive: it is converted to its active form by two hydroxylations: the first in the liver, the second in the kidney, to form calcitriol, whose action is mediated by the vitamin D receptor, a nuclear receptor which regulates the synthesis of hundreds of enzymes and is present in virtually every cell in the body. Calcitriol increases the serum calcium concentrations by increasing GI absorption of phosphorus and calcium, increasing osteoclastic resorption, and increasing distal renal tubular reabsorption of calcium. Calcitriol appears to promote intestinal absorption of calcium through binding to the vitamin D receptor in the mucosal cytoplasm of the intestine. Subsequently, calcium is absorbed through formation of a calcium-binding protein.
Status:
US Approved Rx
(1984)
Source:
ANDA088366
(1984)
Source URL:
First marketed in 1921
Class:
MIXTURE
Conditions:
The ammonium cation is a positively charged polyatomic ion with the chemical formula NH4+. Ammonium ions are a waste product of the metabolism of animals. In fish and aquatic invertebrates, it is excreted directly into the water. In mammals, sharks, and amphibians, it is converted in the urea cycle to urea, because urea is less toxic and can be stored more efficiently. In birds, reptiles, and terrestrial snails, metabolic ammonium is converted into uric acid, which is solid and can therefore be excreted with minimal water loss. Ammonium is an important source of nitrogen for many plant species, especially those growing on hypoxic soils. However, it is also toxic to most crop species and is rarely applied as a sole nitrogen source. The ammonium ion (NH4+) in the body plays an important role in the maintenance of acid-base balance. The kidney uses ammonium (NH4+) in place of sodium (Na+) to combine with fixed anions in maintaining acid-base balance, especially as a homeostatic compensatory mechanism in metabolic acidosis. When a loss of hydrogen ions (H+) occurs and serum chloride (Cl–) decreases, sodium is made available for combination with bicarbonate (HCO3–). This creates an excess of sodium bicarbonate (NaHCO3) which leads to a rise in blood pH and a state of metabolic alkalosis. The therapeutic effects of Ammonium (as Ammonium Chloride) depend upon the ability of the kidney to utilize ammonia in the excretion of an excess of fixed anions and the conversion of ammonia to urea by the liver, thereby liberating hydrogen (H+) and chloride (Cl–) ions into the extracellular fluid.
Status:
US Approved Rx
(1986)
Source:
NDA019513
(1986)
Source URL:
First marketed in 1921
Source:
Potassium Acetate U.S.P.
Source URL:
Class:
MIXTURE
Conditions:
Potassium is needed to maintain good health. When potassium level falls below 3.5 mmol/L, Hypokalemia is diagnosed. In case of extremely low level of potassium (lower than 2.5 mmol/L) the following symptoms are appeared: malaise and fatigue. This low level of potassium can lead to severe muscle weakness and paralysis; respiratory failure; intermittent muscle spasms. It is known, foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke. Potassium supplementation is also recommended as an adjuvant antihypertensive agent for patients with essential hypertension.