NDC codes

FDA NDC Directory
Product NDC (as listed)41520-084Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41520-0084Add 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
41520-084-404152000844041520008440355 mL in 1 BOTTLE (41520-084-40)Marketed from Apr 11, 2016

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)
CareOne Night TIme Cold and Flu
Generic name (nonproprietary)
acetaminophen, dextromethorphan hbr, doxylamine succinate
Active ingredients
Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
Dosage form
Solution
Route
Oral
Labeler
American Sales CompanyNDC labeler code 41520
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 41520-084_87dfb140-d122-4b13-8b52-2903d77ce874SPL ID 87dfb140-d122-4b13-8b52-2903d77ce874SPL set ID d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25RxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Pharmacologic class
Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N441520008440 followed by a unit qualifier and the quantity

Package 41520-0084-40. 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 common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 41520-084

What is NDC 41520-084?
41520-084 is the product NDC for CareOne Night TIme Cold and Flu, Acetaminophen 650 mg/30mL + 2 more ingredients solution, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
CareOne Night TIme Cold and Flu (Acetaminophen, Dextromethorphan HBr, Doxylamine succinate).
What is the active ingredient?
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
Who is the labeler?
American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CareOne Night TIme Cold and Flu?
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
ProductStrengthForm · routeLabelerProduct NDC
MGC Health Cough Drops Honey HerbmentholMenthol 4.8 mg/1LozengeOralMedical Group Care LLC83173-133
Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mgAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralRITE AID11822-1987
daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralKroger Company30142-603
TopCare Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralTOPCO ASSOCIATES LLC36800-367
Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochlorideDextromethorphan hydrobromide 10 mg/1 + 2 more ingredientsCapsule, Liquid filledOralKroger Company41226-693
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralFOODHOLD U.S.A., LLC41520-290
good sense tussin dmdextromethorphan hydrobromide, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mLSolutionOralA-S Medication Solutions50090-7257
SanatosmentholMenthol 5.4 mg/1LozengeOralPharmadel LLC55758-518
Cough DropsmentholMenthol 7.5 mg/1PastilleOralThe Kroger CO59450-716
Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralNavajo Manufacturing Company Inc.67751-244
Childrens Allergy ReliefDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralAllegiant Health69168-471
Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate—KitCVS Pharmacy,Inc.69842-546
Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hclAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1TabletOralCardinal Health 110, LLC. DBA Leader70000-0161
Mucus Reliefguaifenesin 400 mgGuaifenesin 400 mg/1TabletOralPioneer Life Sciences, LLC72090-035
Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hclTriprolidine hydrochloride 1.25 mg/10mL + 2 more ingredientsSolutionOralReckitt Benckiser LLC72854-063
Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mgGuaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1TabletOralUlai Health LLC73057-381
MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride—KitTopco Associates LLC76162-679
24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointmentEucalyptus oil 1.2 g/100g + 2 more ingredientsOintmentTopicalLil' Drug Store Products, Inc.29485-6536
Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate—KitOralBETTER LIVING BRANDS, LLC21130-967
Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl—KitKROGER COMPANY41226-678

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