Over-the-counter drug · OTC MONOGRAPH DRUG
Severe Cold And Flu NDC 51316-533
Acetaminophen 325 mg/15mL + 3 more ingredients · Solution · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51316-533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0533Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-533-40 | 5131605334051316053340 | 355 mL in 1 BOTTLE (51316-533-40)Marketed from Jan 26, 2026 |
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)
- Severe Cold And Flu
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/15mLDextromethorphan hydrobromide — 10 mg/15mLDoxylamine succinate — 6.25 mg/15mLPhenylephrine hydrochloride — 5 mg/15mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-533_4fb8b402-7652-45b9-a458-53102fc5f5d0SPL ID 4fb8b402-7652-45b9-a458-53102fc5f5d0SPL set ID 0d97c634-0975-42d5-8ade-2ed2018cfe9dRxCUI 1431245UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate 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
N451316053340followed by a unit qualifier and the quantityPackage 51316-0533-40. 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 common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
Excerpt only. Read the full label for complete information.
About NDC 51316-533
- What is NDC 51316-533?
- 51316-533 is the product NDC for Severe Cold And Flu, Acetaminophen 325 mg/15mL + 3 more ingredients solution, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Severe Cold And Flu (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.
- Who is the labeler?
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, 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 Severe Cold And Flu?
- 12 other product NDCs are listed under this name. See all Severe Cold And Flu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Severe Cold And Flu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-530 | 51316-0530-08 |
| severe cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | HyVee Inc | 42507-511 | 42507-0511-40 |
| severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | HyVee Inc | 42507-861 | 42507-0861-40 |
| severe cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-293 | 51316-0293-40 |
| Severe Cold and Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HYVEE INC | 42507-278 | 42507-0278-03 |
| Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0525 | 70000-0525-01 |
| Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | SolutionOral | HyVee Inc | 42507-020 | 42507-0020-40 |
| severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Acetaminophen 650 mg/30mL + 3 more ingredients | SolutionOral | Walgreen Company | 0363-0623 | 00363-0623-40 |
| Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | — | Kit | Walgreen Company | 0363-1597 | 00363-1597-02 |
| Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | HyVee Inc | 42507-603 | 42507-0603-40 |
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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