What is NDC 69168-270?

69168-270 is the product NDC for Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy, Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 tablet, listed with the FDA by Allegiant Health. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy (Acetaminophen and Phenylephrine HCl).

What is the active ingredient?

Acetaminophen, Phenylephrine hydrochloride.

Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy?

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 69168-270

NDC codes

FDA NDC Directory

Product NDC (as listed)69168-270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69168-0270Add 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
69168-270-95	69168027095	18 TABLET in 1 BLISTER PACK (69168-270-95)Marketed from Dec 22, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsySuffix: Maximum Strength Non-Drowsy
Generic name (nonproprietary): acetaminophen and phenylephrine hcl
Active ingredients: Acetaminophen — 325 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Allegiant HealthNDC labeler code 69168
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Dec 22, 2014
Marketing end: Oct 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 69168-270_5614edd7-fae9-4261-aa48-bd393f771caaSPL ID 5614edd7-fae9-4261-aa48-bd393f771caaSPL set ID b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5fRxCUI 1046378UNII 362O9ITL9D, 04JA59TNSJUPC 0369168270954
Pharmacologic class: 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

N469168027095 followed by a unit qualifier and the quantity

Package 69168-0270-95. 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 Dec 21, 2018.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-270

What is NDC 69168-270?: 69168-270 is the product NDC for Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy, Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 tablet, listed with the FDA by Allegiant Health. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy (Acetaminophen and Phenylephrine HCl).
What is the active ingredient?: Acetaminophen, Phenylephrine hydrochloride.
Who is the labeler?: Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy?: 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 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
Product	Strength	Form · route	Labeler	Product NDC
365 whole foods market acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Whole Foods Market, INC.	42681-0025
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0657
Acetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0941
Acetaminophen	Acetaminophen 160 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1047
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1314
Acetaminophen	Acetaminophen 325 mg/10.15mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-1882
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1971
Acetaminophen	Acetaminophen 325 mg/10.15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-2094
Acetaminophen	Acetaminophen 650 mg/20.3mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-2823
Acetaminophen	Acetaminophen 650 mg/20.3mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-3141
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-9538
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9595
Acetaminophen	Acetaminophen 160 mg/1	TabletOral	WALGREEN CO.	0363-9605
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	WALGREEN CO.	0363-9798
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Walgreens	0363-9810
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	Rugby Laboratories	0536-1172
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Rugby Laboratories	0536-1292
Acetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Rugby Laboratories	0536-1413
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8608
Acetaminophen	Acetaminophen 325 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8609

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Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy (Acetaminophen and phenylephrine hcl) NDC 69168-270