What is NDC 35916-0185?

35916-0185 is the product NDC for Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Private Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate.

What is the active ingredient?

Acetaminophen, Doxylamine succinate, Dextromethorphan hydrobromide.

Softgel Healthcare Private Limited, 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 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate?

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.

NDC 35916-0185

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-0185Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-0185Add 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
35916-0185-2	3591601850235916018502	3000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0185-2)Marketed from May 17, 2025
35916-0185-3	3591601850335916018503	2 POUCH in 1 BOX (35916-0185-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCHMarketed from Sep 25, 2025
35916-0185-4	3591601850435916018504	2 BAG in 1 BOX (35916-0185-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 16, 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): Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate
Generic name (nonproprietary): acetaminophen, dextromethorphan hbr and doxylamine succinate
Active ingredients: Acetaminophen — 325 mg/1Doxylamine succinate — 6.25 mg/1Dextromethorphan hydrobromide — 10 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Softgel Healthcare Private LimitedNDC labeler code 35916
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: May 17, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 35916-0185_50036e03-a441-a430-e063-6394a90a72c7SPL ID 50036e03-a441-a430-e063-6394a90a72c7SPL set ID 353f71f7-81e0-08c2-e063-6294a90acb49RxCUI 1426334UNII 362O9ITL9D, V9BI9B5YI2, 9D2RTI9KYH
Pharmacologic class: Antihistamine; 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

N435916018502 followed by a unit qualifier and the quantity

Package 35916-0185-02. 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)

Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35916-0185

What is NDC 35916-0185?: 35916-0185 is the product NDC for Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate, Acetaminophen 325 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Private Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate.
What is the active ingredient?: Acetaminophen, Doxylamine succinate, Dextromethorphan hydrobromide.
Who is the labeler?: Softgel Healthcare Private Limited, 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 Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate?: 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
Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	WALGREENS	0363-0100
CVS Health No Dripnasal mist	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	CVS PHARMACY,INC.	69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	The Procter & Gamble Manufacturing Company	69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	Lidl US LLC	71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Amazon.com Services LLC	72288-293
Menthol Cough Drops Honey Vanilla Flavormenthol	Menthol 2.5 mg/1	LozengeOral	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride	—	Kit	Sixarp, LLC	59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hcl	Pseudoephedrine hydrochloride 30 mg/1	Tablet, Film coatedOral	Better Living Brands, LLC	21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oil	Camphor (Synthetic) 4.8 g/100g + 2 more ingredients	CreamTopical	Jell Pharmaceuticals Pvt Ltd.	30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	United Natural Foods, Inc. dba UNFI	41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-044
Childrens Dye Free Allergydiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	P & L Development, LLC	49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Family Dollar Services Inc	55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Dolgencorp Inc	55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 650 mg/20mL + 3 more ingredients	LiquidOral	Haleon US Holdings LLC	0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride	—	KitNasal	Bayer HealthCare LLC.	11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	TabletOral	Selder, S.A. de C.V.	63654-605
Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05%	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	Lil' Drug Store Products, Inc.	66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients	LiquidOral	The Procter & Gamble Manufacturing Company	69423-982

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Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate NDC 35916-0185