What is NDC 35916-0461?

35916-0461 is the product NDC for Dextromethorphan Hydrobromide, Dextromethorphan hydrobromide 15 mg/1 capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 4 package NDCs, shown above in 10- and 11-digit form.

Softgel Healthcare Pvt Ltd, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dextromethorphan Hydrobromide?

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.

Dextromethorphan Hydrobromide NDC 35916-0461

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-0461Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-0461Add 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
35916-0461-1	35916046101	20 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-0461-1)Marketed from Sep 11, 2024
35916-0461-2	35916046102	1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0461-2)Marketed from Mar 18, 2025
35916-0461-3	35916046103	2 POUCH in 1 BOX (35916-0461-3) / 3000 CAPSULE, LIQUID FILLED in 1 POUCHMarketed from Jul 17, 2025
35916-0461-4	35916046104	2 BAG in 1 BOX (35916-0461-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 12, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Dextromethorphan Hydrobromide
Generic name (nonproprietary): dextromethorphan hydrobromide
Active ingredients: Dextromethorphan hydrobromide — 15 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Softgel Healthcare Pvt LtdNDC labeler code 35916
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Sep 11, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 35916-0461_5003763c-806d-cd6b-e063-6294a90a374fSPL ID 5003763c-806d-cd6b-e063-6294a90a374fSPL set ID 20f7c1a9-fc4d-1f51-e063-6394a90a8be3RxCUI 1090487UNII 9D2RTI9KYH
Pharmacologic class: 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

N435916046101 followed by a unit qualifier and the quantity

Package 35916-0461-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 35916-0461

What is NDC 35916-0461?: 35916-0461 is the product NDC for Dextromethorphan Hydrobromide, Dextromethorphan hydrobromide 15 mg/1 capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dextromethorphan Hydrobromide.
What is the active ingredient?: Dextromethorphan hydrobromide.
Who is the labeler?: Softgel Healthcare Pvt Ltd, NDC labeler code 35916. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dextromethorphan Hydrobromide?: 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
Cold and Flu HBPacetaminophen, chlorpheniramine maleate	Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1	Tablet, Film coatedOral	WALMART INC.	79903-120
Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	—	Kit	WALMART INC.	79903-417
Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	P & L Development, LLC	49580-0343
Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	L.N.K. International, Inc.	50844-572
SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, Film coatedOral	Kenvue Brands LLC	50580-450
Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl	Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients	LiquidOral	TARGET CORPORATION	11673-828
Freegells Cough Drops Menthol Cherry 30ctmenthol	Levomenthol 5.8 mg/1	LozengeOral	RL Albert & Son Inc.	83002-040
Sanatosmenthol	Menthol 5.4 mg/1	LozengeOral	Pharmadel LLC	55758-518
Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	VALU MERCHANDISERS COMPANY	63941-173
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl	Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients	SyrupOral	Dextrum Laboratories, Inc	65852-020
Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	CapsuleOral	Chain Drug Consortium, LLC	68016-878
Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	HARRIS TEETER	72036-274
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl	Acetaminophen 1000 mg/30mL + 3 more ingredients	SyrupOral	Haleon US Holdings LLC	0067-0114
Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin	—	Kit	WALMART INC.	79903-414
Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	MEIJER DISTRIBUTION INC	79481-6308
Menthol Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Target Corporation Inc.	82442-001
adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Meijer Distribution Inc	41250-261
Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride	Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients	LiquidOral	Advanced Generic Corporation	45737-250
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	TabletOral	AMERISOURCE BERGEN	46122-829
Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl	—	Kit	L.N.K. International, Inc.	50844-529

Showing 20 of 40.