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 NDC11-digit (billing)PackageCopy
69168-324-8669168032486691680324861 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
Listing expires
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 .

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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cold Multi-Symptomacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralKroger Company30142-47030142-0470-08
Cold Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl—KitWal-Mart Stores Inc49035-93149035-0931-08
Cold Multi-Symptomacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-47055301-0470-08

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
ProductStrengthForm · routeLabelerProduct NDC
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralGrocery Outlet, Inc.85828-922
Pain Relief Regular StrengthacetaminophenAcetaminophen 325 mg/1TabletOralCHAIN DRUG MARKETING ASSOCIATION INC83324-076
equate pain and fever childrensacetaminophenAcetaminophen 160 mg/5mLSuspensionOralWal-Mart Stores Inc49035-042
good neighbor pharmacy childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmerisource Bergen46122-210
AspirinAspirin 81 mg/1Tablet, Delayed releaseOralGOODSENSE50804-880
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralMorning Star OTC53209-1002
AcetaminophenAcetaminophen 500 mg/1TabletOralCardinal Health 107, LLC55154-7897
Headache Formula Extra Strengthacetaminophen, aspirin, caffeineAcetaminophen 250 mg/1 + 2 more ingredientsTablet, Film coatedOralARMY AND AIR FORCE EXCHANGE SERVICE55301-334
childrens pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralWalgreen Company0363-1239
Tylenol PMacetaminophen, diphenhydramine hydrochlorideAcetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralSavings Distributors LLC73097-013
Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonateAnhydrous citric acid 1000 mg/1 + 2 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-4000
Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1260
basic care infants pain and feveracetaminophenAcetaminophen 160 mg/5mLSuspensionOralAmazon.com Services LLC72288-946
AcetaminophenAcetaminophen 500 mg/1TabletOralSportpharm LLC85766-223
Pain Relief Aspirin Low DoseaspirinAspirin 81 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0600
Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonateAspirin 325 mg/1 + 2 more ingredientsTablet, EffervescentOralUnited Natural Foods, Inc. dba UNFI41163-421
Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsLiquidOralChain Drug Consortium, LLC68016-154
Tension Headache ReliefAcetaminophen 500 mg/1; Caffeine 65 mg/1Capsule, CoatedOralAllegiant Health69168-001
Childrens AcetaminophenacetaminophenAcetaminophen 160 mg/5mLSuspensionOralProficient Rx LP71205-263
Chewable AspirinaspirinAspirin 81 mg/1Tablet, ChewableOralChain Drug Marketing Association, Inc.83324-075

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