Over-the-counter drug · OTC MONOGRAPH DRUG
CVS Nighttime Cold and Flu Relief NDC 51316-692
acetaminophen, dextromethorphan hbr, doxylamine succinate · Acetaminophen 650 mg/30mL + 2 more ingredients · Solution · Oral · CVS PHARMACY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-692-12 | 5131606921251316069212 | 354 mL in 1 BOTTLE (51316-692-12)Marketed from Feb 13, 2023 |
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)
- CVS Nighttime Cold and Flu Relief
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hbr, doxylamine succinate
- Active ingredients
- Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- CVS PHARMACYNDC labeler code 51316
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51316-692_8a9c5ccb-85c9-4ec4-ac3a-f42b27856cc7SPL ID 8a9c5ccb-85c9-4ec4-ac3a-f42b27856cc7SPL set ID 87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3RxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
- Pharmacologic class
- Antihistamine; 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
N451316069212followed by a unit qualifier and the quantityPackage 51316-0692-12. 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 common cold/flu symptoms: ▪ cough due to minor throat and bronchial irritation ▪ sore throat ▪ headache ▪ minor aches and pains ▪ fever ▪ runny nose and sneezing
Excerpt only. Read the full label for complete information.
About NDC 51316-692
- What is NDC 51316-692?
- 51316-692 is the product NDC for CVS Nighttime Cold and Flu Relief, Acetaminophen 650 mg/30mL + 2 more ingredients solution, listed with the FDA by CVS PHARMACY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CVS Nighttime Cold and Flu Relief (Acetaminophen, Dextromethorphan HBr, Doxylamine succinate).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- CVS PHARMACY, 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 CVS Nighttime Cold and Flu Relief?
- 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 010
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 |
|---|---|---|---|---|
| ADWE dye-free childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SyrupOral | RARITAN PHARMACEUTICALS INC | 68163-710 |
| Allergy Relief 25 mgdiphenhydramine hcl 25mg | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Ulai Health LLC | 73057-348 |
| AXIV - VroZzzdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Vivunt Pharma LLC | 82706-014 |
| basic care nighttime sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Amazon.com Services LLC | 72288-186 |
| berkley and jensen sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | BJWC | 68391-186 |
| Best Choice Childrens Allergy Relief Bubblegum flavordiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 63941-710 |
| Betr sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Live Betr LLC | 80267-431 |
| Calmco Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/5mL | SolutionOral | CalmCo LLC | 73282-2525 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2527 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2528 |
| CalmCo Sleep Aid Gummy Bitediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo LLC | 73282-2518 |
| careone nighttime sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-431 |
| CVS Childrens Nighttime Multi Symptom Coldacetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride | Acetaminophen 325 mg/10mL + 2 more ingredients | LiquidOral | CVS PHARMACY | 51316-733 |
| CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 59779-893 |
| CVS Nighttime Childrens Cold and Cough Multi-Symptom Reliefchlorpheniramine maleate and dextromethorphan hydrobromide | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | SolutionOral | CVS PHARMACY | 51316-752 |
| CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride | Acetaminophen 650 mg/30mL + 3 more ingredients | SolutionOral | CVS PHARMACY | 51316-641 |
| CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophen | Acetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS PHARMACY | 69842-448 |
| dg health sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Dolgencorp, LLC | 55910-186 |
| dg health sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-431 |
| Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-479 |
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