Blowfish, an over-the-counter hangover cure marketed as federally-approved is set to hit stores throughout the U.S. in January. But questions remain: Is it effective and was it ever approved by the U.S. Food and Drug Administration?

It's the only over-the-counter drug that's specifically hangover related, Blowfish creator Brenna Haysom told ABC News. The [Food and Drug Administration] has specifically said our formula is effective for treating hangover symptoms.

FDA officials weren't so certain about that claim. NBC 12 reports that not only is the new hangover cure, not FDA approved, but it has not even been tested as effective. The FDA told NBC 12 that the administration had not heard of Blowfish until it made headlines recently for being an approved drug.

The confusion seems to stem from a technicality. ABC News reports that because the over-the-counter drug includes ingredients that have been FDA approved, the drug did not need to go through the process of approval before hitting shelves. The process of compounding, taking approved drugs and mixing them for another purpose, has its roots in the original pharmacies a century ago. The FDA does, however, manage the manufacturing process and packaging of the drug.

Whether the FDA approved Blowfish or not, the company claims the drug is effective and offers consumers a money back guarantee.

Blowfish is an effervescent, morning-after hangover remedy that claims to relieve stomach pain, headaches and fatigue. The website encourages consumers suffering from a hangover to let two tablets dissolve in water upon waking with a hangover. Blowfish should fend off a hangover in 15 to 30 minutes.

Each dosage, or two tablets, is composed of 1000 mg of aspirin and 120 mg of caffeine approximately equal to a single cup of coffee. The makers also say the bubbly also helps non-alcohol related aches similar to hangovers like stomach pain, fatigue and headaches.

Haysom, the creator of the drug, insists it is effective and safe. She has said that the cure came out of her own experiences with hangovers. She is a graduate of the Harvard Business School and abandoned a job in finance to create Blowfish.

People are skeptical because there have been so many weird hangover cures over the years, Haysom said, describing herbal hangover remedies not controlled by the FDA. Word of mouth is really important for us.

Blowfish is already sold in Ricky's stores in New York City. The website also claims that Blowfish can be delivered to anyone's home in New York City within 60 minutes. The drug is set to be in stores throughout the U.S. by January and can already be purchased on the company's website.