Over-the-counter drug · OTC MONOGRAPH DRUG
Severe Cold and Flu NDC 51316-530
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl · Acetaminophen 325 mg/1 + 3 more ingredients · Tablet, Film coated · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-530-08 | 51316053008 | 2 BLISTER PACK in 1 CARTON (51316-530-08) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 5, 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 hbr, guaifenesin, phenylephrine hcl
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Guaifenesin — 200 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-530_4de0015b-b93e-4b49-bc0f-d7ddab294d2dSPL ID 4de0015b-b93e-4b49-bc0f-d7ddab294d2dSPL set ID 85aadc86-d979-41a1-849a-e2ccc9014429RxCUI 1110988UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; 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
N451316053008followed by a unit qualifier and the quantityPackage 51316-0530-08. 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 common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| XL-3 Day Timeacetaminophen, dextromethorphan hbr, phenylephrine hcl | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | Rnv LLC | 84379-441 |
| Halls Sugar Free Watermelonmenthol | Menthol 2.5 mg/1 | LozengeOral | Mondelez Global LLC | 12546-351 |
| Xpect Cherry Cough Dropscherry cough drops | Menthol 7 mg/1 | LozengeOral | Cintas Corporation | 42961-232 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATacetaminophen and dextromethorphan hydrobromide | Acetaminophen 160 mg/5mL; Dextromethorphan hydrobromide 5 mg/5mL | SuspensionOral | Kenvue Brands LLC | 50580-194 |
| Nighttime Cough DMdextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mL | SolutionOral | L.N.K. International, Inc. | 50844-043 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 50 mg/1 | Tablet, CoatedOral | CVS Pharmacy, Inc. | 51316-221 |
| DayTime and Nighttime Cold/Flu Relief Softgels - Combo Packacetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate | — | Kit | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-605 |
| Sleep Aid NightTimediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-981 |
| Codeine-Guaifenesincodeine phosphate and guaifenesin | Codeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Method Pharmaceuticals, LLC | 58657-500 |
| Dual Action Glacier Mint Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola USA Inc. | 63667-603 |
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXacetaminophen, dextromethorphan hydrobromide tablet, coated | Dextromethorphan hydrobromide 10 mg/1; Acetaminophen 325 mg/1 | Tablet, CoatedOral | Lil' Drug Store Products, Inc. | 66715-6204 |
| Multi Symptom Severe Coldacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 500 mg/1 + 2 more ingredients | Powder, For solutionOral | RARITAN PHARMACEUTICALS INC | 68163-547 |
| Vicks DayQuil Cough DM plus Congestiondextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-922 |
| dimaphen dmbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL + 2 more ingredients | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8134 |
| Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | Harris Teeter, LLC | 69256-343 |
| Cold and Flu Dayacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | SolutionOral | Walgreen Company | 0363-9912 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | CVS Pharmacy | 69842-820 |
| Allergy Relief Diphenhydramine HCl 25mg SoftGeldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Pioneer Life Sciences, LLC | 72090-052 |
| SofSkin Vaporizing Chest Rub and Cough Suppressantcamphor, menthol, eucalyptus oil | Camphor (Natural) 4.8 g/100g + 2 more ingredients | OintmentTopical | Viny Health and Beauty Inc | 76436-144 |
| Nighttime Cold and Flu Multi Symptom Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0177 |
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