Over-the-counter drug · OTC MONOGRAPH DRUG
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime (Acetaminophen, diphenhydramine hcl) NDC 0031-0101
Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL · Liquid · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0031-0101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00031-0101Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-0101-04 | 0003101010400031010104 | 1 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLEMarketed from Feb 15, 2024 |
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 Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
- Generic name (nonproprietary)
- acetaminophen, diphenhydramine hcl
- Active ingredients
- Acetaminophen — 650 mg/20mLDiphenhydramine hydrochloride — 25 mg/20mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0031
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18SPL ID 0f9df094-b106-76fc-e063-6294a90a6a18SPL set ID 721bfee2-0d3d-4d8b-beee-1ea83064d1c8RxCUI 2374554UNII 362O9ITL9D, TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N400031010104followed by a unit qualifier and the quantityPackage 00031-0101-04. 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 headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves your cough to help you rest temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0031-0101
- What is NDC 0031-0101?
- 0031-0101 is the product NDC for Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime, Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL liquid, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime (Acetaminophen, diphenhydramine hcl).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine 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 Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime?
- 1 other product NDC are listed under this name. See all Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-0100 | 00031-0100-0400031-0100-08 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | WALGREENS | 0363-0100 |
| CVS Health No Dripnasal mist | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CVS PHARMACY,INC. | 69842-815 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 69423-986 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 |
| basic care tussin dm maxdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Amazon.com Services LLC | 72288-293 |
| Menthol Cough Drops Honey Vanilla Flavormenthol | Menthol 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-013 |
| equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride | — | Kit | Sixarp, LLC | 59368-459 |
| Nasal Decongestant Maximum Strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-112 |
| Medicated Chest Rubcamphor, menthol, eucalyptus oil | Camphor (Synthetic) 4.8 g/100g + 2 more ingredients | CreamTopical | Jell Pharmaceuticals Pvt Ltd. | 30400-701 |
| equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-459 |
| NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-044 |
| Childrens Dye Free Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | P & L Development, LLC | 49580-0293 |
| Discount Drug Mart Original Nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-715 |
| Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Family Dollar Services Inc | 55319-705 |
| DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Dolgencorp Inc | 55910-928 |
| Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-8751 |
| Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride | — | KitNasal | Bayer HealthCare LLC. | 11523-0147 |
| Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | Selder, S.A. de C.V. | 63654-605 |
| Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05% | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Lil' Drug Store Products, Inc. | 66715-5526 |
| Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-982 |
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