What is NDC 69168-324?

69168-324 is the product NDC for Cold Multi-Symptom, Acetaminophen 325 mg/1 + 2 more ingredients tablet, coated, 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?

Cold Multi-Symptom (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl).

What is the active ingredient?

Acetaminophen, Dextromethorphan hydrobromide, 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 Cold Multi-Symptom?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cold Multi-Symptom NDC 69168-324 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69168-324Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69168-0324Add 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
69168-324-86	6916803248669168032486	1 BLISTER PACK in 1 CARTON (69168-324-86) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Aug 15, 2015

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): Cold Multi-Symptom
Generic name (nonproprietary): acetaminophen, dextromethorphan hbr, phenylephrine hcl
Active ingredients: Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Allegiant HealthNDC labeler code 69168
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Aug 15, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 69168-324_b31c44ba-30a7-4731-8169-2a3f2a5de4d5SPL ID b31c44ba-30a7-4731-8169-2a3f2a5de4d5SPL set ID 9a4c0c43-a71a-4e22-a3d5-9eb9622689a2RxCUI 1094538UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJUPC 0369168324862
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

N469168032486 followed by a unit qualifier and the quantity

Package 69168-0324-86. 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 2, 2019.

Indications (excerpt from the label)

Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ cough ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69168-324

What is NDC 69168-324?: 69168-324 is the product NDC for Cold Multi-Symptom, Acetaminophen 325 mg/1 + 2 more ingredients tablet, coated, 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?: Cold Multi-Symptom (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl).
What is the active ingredient?: Acetaminophen, Dextromethorphan hydrobromide, 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 Cold Multi-Symptom?: 3 other product NDCs are listed under this name. See all Cold Multi-Symptom NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cold Multi-Symptom NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cold Multi-Symptomacetaminophen, dextromethorphan hbr, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Kroger Company	30142-470	30142-0470-08
Cold Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl	—	Kit	Wal-Mart Stores Inc	49035-931	49035-0931-08
Cold Multi-Symptomacetaminophen, dextromethorphan hbr, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, Film coatedOral	ARMY AND AIR FORCE EXCHANGE SERVICE	55301-470	55301-0470-08

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
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	COSTCO WHOLESALE CORPORATION	63981-019
Extra Strength Pain Releifacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services, LLC	70677-1242
Aspirin 81 mgaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	H E B	37808-600
TYLENOL Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Morning Star OTC	53209-1001
Extra Strength Pain Relieveracetaminophen tablets 500 mg	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)	Acetaminophen 500 mg/1	Capsule, Liquid filledOral	Walgreens	0363-6684
Mommys Bliss Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-793
Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	CVS Pharmacy	59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Amerisource Bergen	46122-211
Acetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	A-S Medication Solutions	50090-6059
Members Mark Acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Sam's West Inc	68196-606
Mommys Bliss Infants Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-893
Thompson Extra Strength Non-Aspirinacetaminophen	Acetaminophen 500 mg/1	TabletOral	Thompson	73408-174
Aspirin 81 mg Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-089
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	ASCLEMED USA INC.	87063-222
Pain Relief Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Rite Aid Corporation	11822-0600
equate pain and fever childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Wal-Mart Stores Inc	49035-042
Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	P & L Development, LLC	49580-0282
Dye Free Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Walgreens	0363-0285
Pain Reliever Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Walgreen Company	0363-0519

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