What is NDC 51316-549?

51316-549 is the product NDC for Theraflu Relief Max Strength Nighttime, Acetaminophen 1000 mg/1 + 2 more ingredients powder, for 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?

Theraflu Relief Max Strength Nighttime (Acetaminophen, Chlorpheniramine Maleate and Dextromethophan HBr).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate.

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 Theraflu Relief Max Strength Nighttime?

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.

Theraflu Relief Max Strength Nighttime NDC 51316-549

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0549Add 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
51316-549-06	5131605490651316054906	1 POWDER, FOR SOLUTION in 1 PACKET (51316-549-06)Marketed from Apr 17, 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): Theraflu Relief Max Strength NighttimeSuffix: Nighttime
Generic name (nonproprietary): acetaminophen, chlorpheniramine maleate and dextromethophan hbr
Active ingredients: Acetaminophen — 1000 mg/1Dextromethorphan hydrobromide — 30 mg/1Chlorpheniramine maleate — 4 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: CVS PHARMACYNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 010
Marketing start: Apr 17, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 51316-549_886c356e-8c85-40c3-a154-ce68fa85d0d9SPL ID 886c356e-8c85-40c3-a154-ce68fa85d0d9SPL set ID 4b567234-1da9-4e10-a427-877eea2be1c1RxCUI 2636658UNII 362O9ITL9D, 9D2RTI9KYH, V1Q0O9OJ9Z
Pharmacologic class: Histamine-1 Receptor Antagonist; 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

N451316054906 followed by a unit qualifier and the quantity

Package 51316-0549-06. 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 these symptoms due to a common cold: ▪ headache ▪ minor aches and pains ▪ cough due to minor throat and bronchial irritation ▪ minor sore throat pain ▪ runny nose ▪ temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-549

What is NDC 51316-549?: 51316-549 is the product NDC for Theraflu Relief Max Strength Nighttime, Acetaminophen 1000 mg/1 + 2 more ingredients powder, for 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?: Theraflu Relief Max Strength Nighttime (Acetaminophen, Chlorpheniramine Maleate and Dextromethophan HBr).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate.
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 Theraflu Relief Max Strength Nighttime?: 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
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen	Diphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mL	LiquidOral	The Procter & Gamble Manufacturing Company	69423-985
Nighttime Sleep Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	BJWC (Berkley & Jensen / BJ's)	68391-793
Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	CapsuleOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-736
Diphenhydramine HCl 25mgsleep aid	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	Allegiant Health	69168-002
berkley and jensen sleep aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/30mL	SolutionOral	BJWC	68391-186
AXIV - VroZzzdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Vivunt Pharma LLC	82706-014
Revasol Sleep Aiddiphenhydramine hcl	Diphenhydramine HCl 50 mg/30mL	LiquidOral	Rnv LLC	84379-284
Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen	Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1	Tablet, CoatedOral	The Procter & Gamble Manufacturing Company	37000-974
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-860
Sleep Tabsdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	TabletOral	Major Pharmaceuticals	0904-4274
Nightime Sleep Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/30mL	LiquidOral	BETTER LIVING BRANDS LLC.	21130-711
Diphenhydramine HCl	Diphenhydramine HCl 50 mg/30mL	LiquidOral	BI-MART	37835-519
Sleep Aid NightTimediphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Wal-Mart Stores Inc	49035-672
Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Best Choice (Valu Merchandisers Company)	63941-916
Nighttime Sleep-Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	BIONPHARMA INC.	69452-427
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	AAA Pharmaceutical, Inc.	57344-091
Sleep Aid	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Better Living Brands LLC	21130-052
Sleep Aiddiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	CapsuleOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-894
Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Capsule, Liquid filledOral	Chain Drug Marketing Association, Inc.	63868-970
Nighttime Sleep Aiddiphenhydramine hcl 50mg	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Grocery Outlet	85828-410

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