Over-the-counter drug · OTC MONOGRAPH DRUG
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime NDC 0031-8752
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride · Acetaminophen 650 mg/20mL + 2 more ingredients · Solution · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-8752-12 | 0003187521200031875212 | 1 BOTTLE in 1 CARTON (0031-8752-12) / 118 mL in 1 BOTTLEMarketed from Jul 1, 2015 | |
| 0031-8752-18 | 0003187521800031875218 | 1 BOTTLE in 1 CARTON (0031-8752-18) / 237 mL in 1 BOTTLEMarketed from Jul 1, 2015 |
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)
- Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime
- Generic name (nonproprietary)
- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 650 mg/20mLDiphenhydramine hydrochloride — 25 mg/20mLPhenylephrine hydrochloride — 10 mg/20mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0031
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 0012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0031-8752_156ef02d-2284-6dc7-e063-6294a90a3be9SPL ID 156ef02d-2284-6dc7-e063-6294a90a3be9SPL set ID 89360fa8-014d-4da8-bb1c-197e3aa52256RxCUI 1375932UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N400031875212followed by a unit qualifier and the quantityPackage 00031-8752-12. 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 occurring with a cold or flu, hay fever, or other respiratory allergies: cough due to minor throat and bronchial irritation nasal congestion headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose and throat temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0031-8752
- What is NDC 0031-8752?
- 0031-8752 is the product NDC for Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime, Acetaminophen 650 mg/20mL + 2 more ingredients solution, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime (Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime?
- 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.