What is NDC 35916-0166?

35916-0166 is the product NDC for Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr, Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr.

What is the active ingredient?

Phenylephrine hydrochloride, Dextromethorphan hydrobromide, Acetaminophen, Guaifenesin.

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 Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr?

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 35916-0166

NDC codes

FDA NDC Directory

Product NDC (as listed)35916-0166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width35916-0166Add 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
35916-0166-1	35916016601	2 BLISTER PACK in 1 CARTON (35916-0166-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Oct 29, 2024

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, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
Generic name (nonproprietary): acetaminophen, guaifenesin, phenylephrine hcl and dextromethorphan hbr
Active ingredients: Phenylephrine hydrochloride — 5 mg/1Dextromethorphan hydrobromide — 10 mg/1Acetaminophen — 325 mg/1Guaifenesin — 200 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: Oct 29, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 35916-0166_47b5293b-c76d-4cd3-e063-6394a90a29b5SPL ID 47b5293b-c76d-4cd3-e063-6394a90a29b5SPL set ID 24bc9ae6-8e8f-c0a0-e063-6394a90a407fRxCUI 1656815UNII 04JA59TNSJ, 9D2RTI9KYH, 362O9ITL9D, 495W7451VQUPC 0335916016617
Pharmacologic class: Expectorant; 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

N435916016601 followed by a unit qualifier and the quantity

Package 35916-0166-01. 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 Jan 28, 2026.

Indications (excerpt from the label)

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35916-0166

What is NDC 35916-0166?: 35916-0166 is the product NDC for Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr, Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients capsule, liquid filled, listed with the FDA by Softgel Healthcare Pvt Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr.
What is the active ingredient?: Phenylephrine hydrochloride, Dextromethorphan hydrobromide, Acetaminophen, Guaifenesin.
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 Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr?: 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 Kids Daytime Dex Cough Gelsdextromethorphan	Dextromethorphan hydrobromide 10 mg/1	Tablet, ChewableOral	Walmart	79903-337
Nuvicare DayTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	NUVICARE LLC	84324-018
MGC Cough Dropsmenthol	Menthol, Unspecified form 5.4 mg/1	LozengeOral	Medical Group Care LLC	83173-109
Pain Reliever PMacetaminophen diphenhydramine hcl	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	QUALITY CHOICE (Chain Drug Marketing Association)	83324-166
Cough Dropsmenthol	Menthol 7.5 mg/1	PastilleOral	United Natural Foods, Inc.	83455-203
Better Livingphenylephrine hydrochloride	Phenylephrine hydrochloride 1 g/100mL	SprayNasal	BETTER LIVING BRANDS LLC	21130-728
Sinus Congestion and Pain Relief Non-Drowsy/Daytimeacetaminophen, guaifenesin and phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Rite Aid Corporation	11822-0527
nasaloxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	Spray, MeteredNasal	Rite Aid Corporation	11822-6319
Childrens Sudafed Nasal Decongestantpseudoephedrine hydrochloride	Pseudoephedrine hydrochloride 15 mg/5mL	SolutionOral	Kenvue Brands LLC	50580-536
Dye Free Wal Dryl Allergy childrensdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	Walgreens	0363-0293
Childrens Giltuss Honey Cough and Chest Congestiondextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL	SolutionOral	Dextrum Laboratories, Inc	65852-003
Severe Sinus Daytime, Non-Drowsyacetaminophen, guaifenesin, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Walgreen Company	0363-5027
Leader Nasal Decongestantoxymetazoline hydrochloride	Oxymetazoline hydrochloride .5 mg/mL	SprayNasal	Cardinal Health 110,Inc	70000-0676
Akin Cough Formula DMdextromethorphan, guaifenesin	Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	Southern Sales & Service, Inc.	69822-202
CVS Health Chest Congestion Relief PEguaifenesin/phenylephrine	Guaifenesin 400 mg/1; Phenylephrine hydrochloride 10 mg/1	TabletOral	CVS Pharmacy, Inc.	69842-997
Sinus Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	Harris Teeter	72036-119
Cough Drops Dollar General Assorted Flavors 80ctmenthol	Menthol 2.8 mg/1	LozengeOral	Dollar General	75712-042
Mucinex Instasoothe Coughdextromethorphan hydrobromide	Dextromethorphan hydrobromide 5 mg/1	LozengeOral	Reckitt Benckiser LLC	72854-267
Rayo Breath Chamomilementhol, camphor	Menthol 1 g/g; Camphor (Synthetic) 1 g/g	CreamTopical	Quimicas Handal de Centroamerica SA de CV	83033-1620
MGC Healthcough drops cherry	Menthol 5.8 mg/1	LozengeOral	Medical Group Care LLC	83173-100

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Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr NDC 35916-0166