Prescription medicine

Phenylephrine and promethazine First approved as Phenergan Vc

Phenylephrine and promethazine (Phenergan Vc) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 2 generic labelers.

Generic listed

Check it at the source: the phenylephrine and promethazine FDA label on DailyMed (effective October 30, 2024, Amneal Pharmaceuticals LLC); the NDA 8604 record on Drugs@FDA; every phenylephrine and promethazine label on DailyMed.

Highlights of the record

FDA label of October 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Forms and strengths

6.25 mg/5ml / 5 mg/5ml

Solution.

On the market

Earliest approval on file: September 14, 1954 Phenergan Vc, Ani Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 7 first November 8, 1984; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC): 2 of which 2 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is phenylephrine and promethazine used for?

From the label: indications and usage
Promethazine hydrochloride and phenylephrine hydrochloride oral solution, USP is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

FDA pharmacologic class: Phenothiazine and alpha-1 Adrenergic Agonist.

Source: FDA drug label (Promethazine Hydrochloride and Phenylephrine Hydrochloride), Amneal Pharmaceuticals LLC, effective October 30, 2024 (SPL set cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4), via openFDA; the full label on DailyMed

Is there a generic for phenylephrine and promethazine (Phenergan Vc)?

The FDA approved the first generic phenylephrine and promethazine on November 8, 1984. 7 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists phenylephrine and promethazine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1954 earliest approval on file
1984 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other phenothiazines: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other