What is NDC 51316-578?

51316-578 is the product NDC for Childrens Cold and Cough, Brompheniramine maleate 2 mg/10mL + 2 more ingredients liquid, listed with the FDA by CVS. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Childrens Cold and Cough (Brompheniramine maleate, Dextromethorphan, Phenylephrine HCl).

What is the active ingredient?

Brompheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.

CVS, 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 Childrens Cold and Cough?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Childrens Cold and Cough NDC 51316-578

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-578Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0578Add 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
51316-578-03	5131605780351316057803	1 BOTTLE in 1 CARTON (51316-578-03) / 118 mL in 1 BOTTLEMarketed from Jan 17, 2025

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): Childrens Cold and Cough
Generic name (nonproprietary): brompheniramine maleate, dextromethorphan, phenylephrine hcl
Active ingredients: Brompheniramine maleate — 2 mg/10mLDextromethorphan hydrobromide — 10 mg/10mLPhenylephrine hydrochloride — 5 mg/10mL
Dosage form: Liquid
Route: Oral
Labeler: CVSNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Jan 17, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 51316-578_341dde12-06f5-4baf-9ce1-38f4ee5f95f1SPL ID 341dde12-06f5-4baf-9ce1-38f4ee5f95f1SPL set ID 2bc3eae8-ffe6-bc96-e063-6394a90a2283RxCUI 1090463UNII IXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ
Pharmacologic class: 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

N451316057803 followed by a unit qualifier and the quantity

Package 51316-0578-03. 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 Mar 16, 2026.

Indications (excerpt from the label)

USES temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51316-578

What is NDC 51316-578?: 51316-578 is the product NDC for Childrens Cold and Cough, Brompheniramine maleate 2 mg/10mL + 2 more ingredients liquid, listed with the FDA by CVS. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Childrens Cold and Cough (Brompheniramine maleate, Dextromethorphan, Phenylephrine HCl).
What is the active ingredient?: Brompheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride.
Who is the labeler?: CVS, 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 Childrens Cold and Cough?: 5 other product NDCs are listed under this name. See all Childrens Cold and Cough NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Childrens Cold and Cough NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
childrens cold and coughbrompheniramine maleate, dextromethorphan hydrobromide	Brompheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL	SolutionOral	HyVee Inc	42507-727	42507-0727-26
Childrens Cold And Coughbrompheniramine maleate, dextromethorphan hydrobromide	Brompheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL	SolutionOral	Kroger Company	30142-780	30142-0780-26
Childrens Cold And Coughbrompheniramine maleate, dextromethorphan hydrobromide	Brompheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL	SolutionOral	H E B	59640-200	59640-0200-26
childrens cold and coughbrompheniramine maleate, dextromethorphan hydrobromide	Brompheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL	SolutionOral	Major Pharmaceuticals	0904-7531	00904-7531-20
Childrens Cold and Coughonion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal	Sulfur 12 [hp_X]/mL + 6 more ingredients	LiquidOral	Walgreen Company	0363-9997	00363-9997-01

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
Product	Strength	Form · route	Labeler	Product NDC
Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl	Acetaminophen 650 mg/30mL + 3 more ingredients	LiquidOral	The Kroger Co.	30142-722
Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	—	Kit	HyVee Inc	42507-598
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	H E B	37808-932
Medi First Plus Cherry Cough Dropsmenthol	Menthol 7.6 mg/1	LozengeOral	Unifirst First Aid Corporation	47682-915
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl	Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients	SyrupOral	Kramer Novis	52083-057
SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin	Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1	TabletOral	KRAMER LABORATORIES	55505-231
Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl	Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients	Solution/ dropsOral	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	54859-606
Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 325 mg/15mL + 2 more ingredients	SolutionOral	Dolgencorp Inc	55910-753
Acetaminophen and Diphenhydramine citrate	Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1	TabletOral	InvaTech Pharma Solutions LLC	57631-010
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SolutionNasal	Reckitt Benckiser LLC	63824-120
Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride	Oxymetazoline hydrochloride .0005 g/mL	SprayNasal	Procter & Gamble Manufacturing GmbH	64336-002
Walgreens Honey Lemon Cough Dropsmenthol	Menthol 7.5 mg/1	LozengeOral	Walgreens	0363-9959
Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl	Acetaminophen 500 mg/20mL + 3 more ingredients	SyrupOral	OPMX LLC	69729-787
Guaifenesin	Guaifenesin 400 mg/1	TabletOral	Bryant Ranch Prepack	71335-9616
Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	Harris Teeter	72036-175
DG Health Cough Drops Cherry Flavormenthol	Menthol 5.8 mg/1	LozengeTopical	Dollar General Corporation	75712-005
Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	NUVICARE LLC	84324-019
Quality Choice Mucus Reliefguaifenesin	Guaifenesin 400 mg/1	TabletOral	Chain Drug Marketing Association	83324-194
Diphenhydramine HCl	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Major Pharmaceuticals	0904-6985
severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Rite Aid Corporation	11822-3120

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