Quick answers
- What is Coltalin?
- Coltalin is a brand name of Acetaminophen, chlorpheniramine and phenylephrine, Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine and Acetaminophen and phenylephrine, an over-the-counter medicine. The FDA NDC Directory lists 8 Coltalin products in 3 strengths and forms.
- Who makes Coltalin?
- Fortune Pharmacal Company Limited lists 8 of the 8 Coltalin products in the FDA NDC Directory.
- Is there a generic or store brand of Coltalin?
- Yes. The FDA NDC Directory lists 19 other products with the same active ingredients, strength and form as a Coltalin product, 19 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has Coltalin been recalled?
- No recall linked to Coltalin products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Coltalin is
Each Coltalin product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Acetaminophen, chlorpheniramine and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · chlorpheniramine maleate 2 mg · phenylephrine hydrochloride 5 mg tablet (oral) | Coltalin, Extra Fast Coltalin | 7 products, 6 companies | — |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, chlorpheniramine and phenylephrine →
Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · chlorpheniramine maleate 2 mg · dextromethorphan hydrobromide 10 mg · phenylephrine hydrochloride 5 mg tablet (oral) | Coltalin-Dm | 1 product, 1 company | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen, chlorpheniramine, dextromethorphan and phenylephrine →
Acetaminophen and phenylephrine · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · phenylephrine hydrochloride 5 mg tablet (oral) | Coltalin-Nd | 11 products, 11 companies | — |
Its page quotes the Drug Facts label and lists every brand and store brand: Acetaminophen and phenylephrine →
FDA approval
Coltalin products are sold under an FDA over-the-counter monograph: rules that set the allowed active ingredients, strengths and label wording, so these products do not need an individual FDA approval.
Companies that list Coltalin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Coltalin products.
- Fortune Pharmacal Company Limited8 products
Recalls
No recall linked to Coltalin products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.