Pre-1938 Drugs Not Approved by FDA

In 1938, a bill was passed to revise the 1906 Food and Drugs Act. This Federal Food Drug and Cosmetic Act required that drugs be shown to meet certain safety requirements prior to their being marketed. Drugs that were already on the market were "grandfathered" and allowed to remain on the market without further regulatory approval if they were labeled with the same conditions of use. Many of these products remain on the market today. Technically, these products have never been approved by the FDA and do not appear in the "Orange Book" because they are not approved drug products with therapeutic equivalence evaluations.

The following list may not be complete but will be updated as we become aware of items that have been omitted. The primary resource for this information is the volume entitled, USP Drug Information, Volume III, Approved Drug Products and Legal Requirements.

  • Acetaminophen, Aspirin, Salicylamide, Codeine Phosphate, and Caffeine
    • Tablets
    • Acetaminophen, Codeine Phosphate, and Caffeine
    • Capsules
    • Tablets
  • Amobarbital
    • Tablets
  • Amobarbital Sodium
    • Capsules
    • Sterile
  • Amyl Nitrate
    • Inhalant
  • Antipyrine and Benzocaine
    • Solution, Otic
  • Aspirin and Codeine Phosphate<
    • Tablets
  • Chloral Hydrate
    • Capsules
    • Syrup
    • Suppositories
  • Codeine and Calcium Iodide
    • Syrup
  • Codeine Phosphate
    • Injection
    • Solution, Oral
    • Tablets
    • Tablets, Soluble
    • Codeine Sulfate
    • Tablets
    • Tablets, Soluble
  • Colchicine
    • Injection
    • Tablets
  • Digitoxin
    • Tablets
    • Digoxin
    • Elixir
    • Tablets
  • Ephedrine Sulfate
    • Capsules
    • Injection
  • Ergonovine Maleate
    • Injection
    • Tablets
  • Ergotamine Tartrate
    • Tablets
  • Erythrityl Tetranitrate
    • Tablets
  • Hydrocodone Bitartrate
    • Tablets
  • Hydrocodone Bitartrate, Aspirin, and Caffeine
    • Tablets
  • Hydromorphone Hydrochloride
    • Suppositories
    • Iodinated Glycerol
    • Elixir
    • Solution, Oral
    • Tablets
  • Levothyroxine Sodium
    • for Injection
  • Mephobarbital
    • Tablets
  • Methenamine Mandelate
    • for Solution, Oral
    • Suspension, Oral
    • Tablets
    • Tablets (Enteric-coated)
  • Morphine Hydrochloride
    • Suppositories
  • Morphine Sulfate
    • Solution, Oral
    • Tablets
  • Nitroglycerin
    • Tablets (Sublingual)
  • Opium Alkaloids Hydrochlorides
    • Injection
  • Opium Tincture
    • Oxycodone
    • Tablets
  • Oxycodone Hydrochloride
    • Solution, Oral
  • Pancrelipase
    • Capsules
    • Delayed-Release Capsules
    • Tablets
  • Paregoric
  • Pentaerythritol Tetranitrate
    • Tablets
  • Phenazopyridine Hydrochloride
    • Tablets
  • Phenobarbital
    • Capsules
    • Elixir
    • Tablets
  • Phenobarbital Sodium
    • Injection
    • Sterile
  • Pilocarpine Hydrochloride
    • Solution, Ophthalmic
  • Pilocarpine Nitrate
    • Solution, Ophthalmic
  • Potassium Bicarbonate
    • Effervescent Tablets for Oral Solution
  • Potassium Bicarbonate and Potassium Chloride
    • for Effervescent Oral Solution
    • Effervescent Tablets for Oral Solution
  • Potassium Bicarbonate and Potassium Citrate
    • Effervescent Tablets for Oral Solution
  • Potassium Chloride
    • Solution, Oral
  • Potassium Chloride, Potassium Bicarbonate and Potassium Citrate
    • Effervescent Tablets for Oral Solution
  • Potassium Gluconate
    • Elixir
    • Tablets
  • Potassium Gluconate and Potassium Chloride
    • Solution, Oral
    • for Solution, Oral
  • Potassium Gluconate and Potassium Citrate
    • Solution, Oral
  • Potassium Iodide
    • Solution, Oral
    • Syrup
    • Tablets (Enteric-coated)
  • Monobasic Potassium Phosphate
    • Tablets for Oral Solution
  • Potassium Phosphates
    • Capsules for Oral Solution
    • for Solution, Oral
  • Potassium and Sodium Phosphates
    • Capsules for Oral Solution
    • for Solution, Oral
    • Tablets for Oral Solution
  • Monobasic Potassium and Sodium Phosphates
    • Tablets for Oral Solution
    • Quinine
    • Capsules
  • Quinine Sulfate
    • Tablets
    • Salsalate
    • Capsules
    • Tablets
  • Secobarbital Sodium and Amobarbital Sodium
    • Capsules
    • Sodium Fluoride
    • Solution, Oral
    • Tablets
    • Thyroid
    • Tablets
  • Trikates (Potassium Acetate, Potassium Bicarbonate, and Potassium Citrate)
    • Solution, Oral