What is NDC 50991-540?

50991-540 is the product NDC for Duratuss AC, Codeine phosphate 10 mg/5mL; Dexbrompheniramine maleate 1 mg/5mL liquid, listed with the FDA by Poly Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Duratuss AC (Codeine Phosphate, Dexbrompheniramine Maleate).

What is the active ingredient?

Codeine phosphate, Dexbrompheniramine maleate.

Poly Pharmaceuticals, Inc., NDC labeler code 50991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Duratuss AC?

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.

Duratuss AC NDC 50991-540 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50991-540Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50991-0540Add 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
50991-540-16	5099105401650991054016	473 mL in 1 BOTTLE (50991-540-16)Marketed from Sep 8, 2025
50991-540-20	5099105402050991054020	20 mL in 1 BOTTLE (50991-540-20)Marketed from Sep 8, 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): Duratuss AC
Generic name (nonproprietary): codeine phosphate, dexbrompheniramine maleate
Active ingredients: Codeine phosphate — 10 mg/5mLDexbrompheniramine maleate — 1 mg/5mL
Dosage form: Liquid
Route: Oral
Labeler: Poly Pharmaceuticals, Inc.NDC labeler code 50991
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Sep 8, 2025
Listing expires: Dec 31, 2026
DEA schedule: CV
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91dbSPL ID 3e5ed178-d5d8-b8d4-e063-6394a90a91dbSPL set ID 3e5ed178-d5d9-b8d4-e063-6394a90a91dbRxCUI 2727418UNII GSL05Y1MN6, BPA9UT29BS
Pharmacologic class: Opioid 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

N450991054016 followed by a unit qualifier and the quantity

Package 50991-0540-16. 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 Sep 9, 2025.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50991-540

What is NDC 50991-540?: 50991-540 is the product NDC for Duratuss AC, Codeine phosphate 10 mg/5mL; Dexbrompheniramine maleate 1 mg/5mL liquid, listed with the FDA by Poly Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Duratuss AC (Codeine Phosphate, Dexbrompheniramine Maleate).
What is the active ingredient?: Codeine phosphate, Dexbrompheniramine maleate.
Who is the labeler?: Poly Pharmaceuticals, Inc., NDC labeler code 50991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Duratuss AC?: 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 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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