Over-the-counter drug · NDA
Advil Multi-Symptom Cold and Flu NDC 0573-0190
chlorpheniramine maleate, ibuprofen, phenylephrine hcl · 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 |
|---|---|---|---|
| 0573-0190-01 | 0057301900100573019001 | 50 POUCH in 1 TRAY (0573-0190-01) / 1 TABLET, COATED in 1 POUCHMarketed from Jun 25, 2018 | |
| 0573-0190-02 | 0057301900200573019002 | 2 POUCH in 1 CARTON (0573-0190-02) / 1 TABLET, COATED in 1 POUCHMarketed from Nov 1, 2019 | |
| 0573-0190-03 | 0057301900300573019003 | 3000 POUCH in 1 CASE (0573-0190-03) / 1 TABLET, COATED in 1 POUCHMarketed from Jun 25, 2018 | |
| 0573-0190-10 | 0057301901000573019010 | 1 BLISTER PACK in 1 CARTON (0573-0190-10) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Jun 25, 2018 | |
| 0573-0190-20 | 0057301902000573019020 | 2 BLISTER PACK in 1 CARTON (0573-0190-20) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Jun 25, 2018 | |
| 0573-0190-30 | 0057301903000573019030 | 3 BLISTER PACK in 1 CARTON (0573-0190-30) / 10 TABLET, COATED in 1 BLISTER PACKMarketed from Jun 25, 2018 |
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 Multi-Symptom Cold and Flu
- Generic name (nonproprietary)
- chlorpheniramine maleate, ibuprofen, phenylephrine hcl
- Active ingredients
- Chlorpheniramine maleate — 4 mg/1Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0573
- 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 0573-0190_4042cf07-a239-1ae9-e063-6394a90acd01SPL ID 4042cf07-a239-1ae9-e063-6394a90acd01SPL set ID 7671d104-3c5c-4f63-b6b1-6c91c22592f8RxCUI 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
N400573019001followed by a unit qualifier and the quantityPackage 00573-0190-01. 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 the common cold or flu: headache fever minor body aches and pains nasal congestion runny nose sinus pressure sneezing reduces swelling of the nasal passages temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
About NDC 0573-0190
- What is NDC 0573-0190?
- 0573-0190 is the product NDC for Advil Multi-Symptom Cold and Flu, Chlorpheniramine maleate 4 mg/1 + 2 more ingredients tablet, coated, listed with the FDA by Haleon US Holdings LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Advil Multi-Symptom Cold and Flu (Chlorpheniramine maleate, ibuprofen, phenylephrine HCl).
- What is the active ingredient?
- Chlorpheniramine maleate, Ibuprofen, Phenylephrine hydrochloride.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Advil Multi-Symptom Cold and Flu?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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, and phenylephrine hydrochloride | Chlorpheniramine maleate 4 mg/1 + 2 more ingredients | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-0196 |
| Advil Allergy and Congestion Reliefchlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride | Chlorpheniramine maleate 4 mg/1 + 2 more ingredients | Tablet, CoatedOral | Haleon US Holdings LLC | 0573-2161 |
| 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 |