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

Current FDA label (SPL), effective Apr 27, 2026.

Indications (excerpt from the label)

Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
equate allergy reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	TabletOral	WALMART INC.	79903-297
Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl	Doxylamine succinate 12.5 mg/30mL + 3 more ingredients	LiquidOral	Grocery Outlet, Inc.	85828-775
Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Belmora LLC	27854-299
Allergy Reliefdiphenhydramine hcl 25 mg	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Lil' Drug Store Products, Inc.	29485-9285
Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl	—	Kit	Kroger Company	30142-616
nasal decongestantoxymetazoline hcl	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	A-S Medication Solutions	50090-5281
Discount drug mart Extra Moisturizingoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-720
Throat Comfort Orange Mint Cinnamon Dropsmenthol	Menthol 3.6 mg/1	LozengeOral	Ricola Ag	54305-342
Geri-Tussin DMdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	Geri-Care Pharmaceuticals, Corp	57896-661
Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbr	Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mL	LiquidOral	FAMILY DOLLAR SERVICES INC	55319-754
Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl	Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1	TabletOral	DOLGENCORP, LLC	55910-925
Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hcl	Guaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1	TabletOral	Gil Pharmaceutical Corp	58552-332
Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate	—	Kit	Haleon US Holdings LLC	0031-2099
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestion	Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients	Capsule, Liquid filledOral	Bayer HealthCare LLC.	0280-0505
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride	Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients	SolutionOral	Reckitt Benckiser LLC	63824-956
Major Nasal Decongestantoxymetazoline hydrochloride	Oxymetazoline hydrochloride .5 mg/mL	SprayNasal	NuCare Pharmaceuticals, Inc.	68071-3858
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-1799
nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Walgreen Company	0363-2029
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 50 mg/1	TabletOral	BIONPHARMA INC.	69452-445
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci	—	Kit	CVS Pharmacy	69842-820

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