Over-the-counter drug · OTC MONOGRAPH DRUG
Cough and Sore Throat NDC 51316-662
acetaminophen, dextromethorphan hydrobromide liquid · Acetaminophen 650 mg/20mL; Dextromethorphan hydrobromide 20 mg/20mL · Liquid · Oral · CVS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-662-03 | 51316066203 | 180 mL in 1 BOTTLE (51316-662-03)Marketed from May 23, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Cough and Sore Throat
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide liquid
- Active ingredients
- Acetaminophen — 650 mg/20mLDextromethorphan hydrobromide — 20 mg/20mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- CVSNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-662_3161682c-7349-d0ce-e063-6294a90ad18cSPL ID 3161682c-7349-d0ce-e063-6294a90ad18cSPL set ID 2d13564a-e8d1-c357-e063-6394a90ad90eRxCUI 1919076UNII 362O9ITL9D, 9D2RTI9KYH
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate 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
N451316066203followed by a unit qualifier and the quantityPackage 51316-0662-03. 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: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep minor aches and pains sore throat headache temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 51316-662
- What is NDC 51316-662?
- 51316-662 is the product NDC for Cough and Sore Throat, Acetaminophen 650 mg/20mL; Dextromethorphan hydrobromide 20 mg/20mL liquid, listed with the FDA by CVS. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cough and Sore Throat (Acetaminophen, Dextromethorphan Hydrobromide liquid).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide.
- Who is the labeler?
- CVS, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cough and Sore Throat?
- 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 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 |
|---|---|---|---|---|
| topcare tussin cf maxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Topco Associates LLC | 76162-000 |
| SEVERE CONGESTION and COUGH MAXdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | AptaPharma Inc. | 76281-517 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-304 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Pseudoephedrine Hydrochloride | Pseudoephedrine hydrochloride 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6728 |
| Nighttime Cold and Flu Liquidacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | TARGET CORPORATION | 11673-287 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-494 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | KROGER COMPANY | 41226-272 |
| sinus pressure and pain peacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | GOODSENSE | 50804-220 |
| Mucinex Sinus-Max Severe Congestion Reliefacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Reckitt Benckiser LLC | 63824-201 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-676 |
| Childrens Wal Tap Elixer Cold and Allergybrompheniramine maleate, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL; Phenylephrine hydrochloride 5 mg/10mL | LiquidOral | Walgreens | 0363-0312 |
| Vicks NyQuil Kids BERRY COLD and COUGH plus RUNNY NOSEchlorpheniramine maleate, dextromethorphan hbr | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-779 |
| Night-Time Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | HealthLife of USA | 69517-161 |
| Tylenol Sinus Severeacetaminophen | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | R J General Corporation | 70264-026 |
| Tussin Expectorantguaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | AptaPharma, Inc. | 76281-507 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1101 |
| Equate Severe Menthol Throat Dropmenthol | Menthol 20 mg/1 | LozengeOral | Walmart | 79903-254 |
| Nighttime Cold And Flu Relief Softgels Multi-Symptomacetaminophen, dextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Gelatin coatedOral | Advanced Rx LLC | 80513-302 |
| Vicks NyQuil-D COLD and SINUS plus SEVERE CONGESTIONacetaminophen, pseudoephedrine hcl, doxylamine succinate, dextromethorphan hbr | Doxylamine succinate 6.25 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | The Procter & Gamble Manufacturing Company | 84126-364 |
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