Over-the-counter drug · NDA
Advil Allergy and Congestion Relief NDC 0573-2161
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride · Chlorpheniramine maleate 4 mg/1 + 2 more ingredients · Tablet, Coated · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0573-2161-03 | 00573216103 | 2 BLISTER PACK in 1 CARTON (0573-2161-03) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Oct 1, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Advil Allergy and Congestion Relief
- Generic name (nonproprietary)
- chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride
- Active ingredients
- Chlorpheniramine maleate — 4 mg/1Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Haleon US Holdings LLC
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022113
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0573-2161_ac233de1-41cf-4ef0-a7b4-30f395c88c1aSPL ID ac233de1-41cf-4ef0-a7b4-30f395c88c1aSPL set ID a6cc97d8-252a-4527-a470-6d9e356342fdRxCUI 1310503UNII V1Q0O9OJ9Z, WK2XYI10QM, 04JA59TNSJ
- Pharmacologic class
- Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400573216103followed by a unit qualifier and the quantityPackage 00573-2161-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: • runny nose • itchy, watery eyes • itching of the nose or throat • sneezing • nasal congestion • sinus pressure • headache • minor body aches and pains • fever • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022113
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride | Chlorpheniramine maleate 4 mg/1 + 2 more ingredients | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-149 |
| Advil Multi-Symptom Cold and Fluchlorpheniramine maleate, ibuprofen, phenylephrine hcl | Chlorpheniramine maleate 4 mg/1 + 2 more ingredients | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-0190 |
| Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride | Chlorpheniramine maleate 4 mg/1 + 2 more ingredients | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-0196 |