What is NDC 51316-641?

51316-641 is the product NDC for CVS NightTime Cold, Acetaminophen 650 mg/30mL + 3 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 (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.

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?

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.

CVS NightTime Cold NDC 51316-641 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-641Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0641Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51316-641-12	5131606411251316064112	354 mL in 1 BOTTLE, PLASTIC (51316-641-12)Marketed from Jan 9, 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
Generic name (nonproprietary): acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
Active ingredients: Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 20 mg/30mLDoxylamine succinate — 12.5 mg/30mLPhenylephrine hydrochloride — 10 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: Jan 9, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 51316-641_418a3592-639f-47ec-8717-87fe77e0d837SPL ID 418a3592-639f-47ec-8717-87fe77e0d837SPL set ID 0f0cc40d-7939-4d4d-a931-b4de4070fea1RxCUI 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

N451316064112 followed by a unit qualifier and the quantity

Package 51316-0641-12. 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 Aug 14, 2026.

Indications (excerpt from the label)

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & 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.

Full label on DailyMed (opens in a new tab)

About NDC 51316-641

What is NDC 51316-641?: 51316-641 is the product NDC for CVS NightTime Cold, Acetaminophen 650 mg/30mL + 3 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 (Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride.
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?: 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.

FDA NDC Directory listings under M 010
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 Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	CVS PHARMACY	51316-692
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

Showing 20 of 39.