What is NDC 35916-0188?

35916-0188 is the product NDC for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg, Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Private Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg (Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl).

What is the active ingredient?

Phenylephrine hydrochloride, Dextromethorphan hydrobromide, Acetaminophen.

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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg?

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 35916-0188

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-0188Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-0188Add 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
35916-0188-1	3591601880135916018801	1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0188-1)Marketed from Mar 21, 2025
35916-0188-2	3591601880235916018802	2 POUCH in 1 BOX (35916-0188-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCHMarketed from Jun 12, 2025
35916-0188-3	3591601880335916018803	2 POUCH in 1 BOX (35916-0188-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCHMarketed from Sep 25, 2025
35916-0188-4	3591601880435916018804	2 BAG in 1 BOX (35916-0188-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Jan 13, 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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
Generic name (nonproprietary): acetaminophen, dextromethorphan hbr and phenylephrine hcl
Active ingredients: Phenylephrine hydrochloride — 5 mg/1Dextromethorphan hydrobromide — 10 mg/1Acetaminophen — 325 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: Mar 21, 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 35916-0188_5003542f-a0ff-cd67-e063-6294a90aee97SPL ID 5003542f-a0ff-cd67-e063-6294a90aee97SPL set ID 30ab39f3-27cc-5728-e063-6394a90a9cbeRxCUI 1086997UNII 04JA59TNSJ, 9D2RTI9KYH, 362O9ITL9D
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

N435916018801 followed by a unit qualifier and the quantity

Package 35916-0188-01. 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)

Uses • temporarily relieves these symptoms due to a cold or flu: • minor aches and pains • headache • cough •sore throat • nasal and sinus congestion •temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35916-0188

What is NDC 35916-0188?: 35916-0188 is the product NDC for Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg, Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Private Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg (Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl).
What is the active ingredient?: Phenylephrine hydrochloride, Dextromethorphan hydrobromide, Acetaminophen.
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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg?: 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 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg NDC 35916-0188