Over-the-counter drug · OTC MONOGRAPH DRUG

Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime NDC 50580-212

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate · Doxylamine succinate 12.5 mg/30mL + 2 more ingredients · Liquid · Oral · Kenvue Brands LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)50580-212Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50580-0212Add 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
50580-212-0150580021201240 mL in 1 BOTTLE (50580-212-01)Marketed from Jun 1, 2026

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

Generic name (nonproprietary)
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Active ingredients
Doxylamine succinate — 12.5 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLAcetaminophen — 1000 mg/30mL
Dosage form
Liquid
Route
Oral
Labeler
Kenvue Brands LLCNDC labeler code 50580
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 50580-212_5254872f-1467-509b-e063-6394a90a7d81SPL ID 5254872f-1467-509b-e063-6394a90a7d81SPL set ID 525467fb-510d-0b4b-e063-6294a90acd36RxCUI 2744316UNII V9BI9B5YI2, 9D2RTI9KYH, 362O9ITL9DUPC 0300450522092
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

N450580021201 followed by a unit qualifier and the quantity

Package 50580-0212-01. 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 .

Indications (excerpt from the label)

Uses ■ temporarily relieves these common cold/flu symptoms ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ sneezing and runny nose ■ temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50580-212

What is NDC 50580-212?
50580-212 is the product NDC for Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime, Doxylamine succinate 12.5 mg/30mL + 2 more ingredients liquid, listed with the FDA by Kenvue Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime (Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate).
What is the active ingredient?
Doxylamine succinate, Dextromethorphan hydrobromide, Acetaminophen.
Who is the labeler?
Kenvue Brands LLC, NDC labeler code 50580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime?
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
Childrens Benadryl ALLERGYdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralKenvue Brands LLC50580-534
Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralDISCOUNT DRUG MART53943-138
Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralThe Kroger Co.59450-046
CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochlorideAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralCVS PHARMACY, INC69842-966
Sinus Head Congestionacetaminophen, phenylephrine hydrochlorideAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1Capsule, Liquid filledOralVIVUNT PHARMA LLC82706-025
Leader Cough Drops Vanilla HoneymentholMenthol, Unspecified form 2.5 mg/1LozengeOralXiamen Kang Zhongyuan Biotechnology Co., Ltd.83698-692
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralHEB37808-590
Oxymetazoline HydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalBi-Mart37835-996
Vaporxcamphor (synthetic), eucalyptus oil, and mentholCamphor (Synthetic) .048 g/g + 2 more ingredientsOintmentTopicalAKRON PHARMA INC71399-4589
Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oilMenthol 1 g/100g + 2 more ingredientsOintmentTopicalGLOBAL IMPORT SALES LLC72146-008
Adult Allergy Reliefcalmco allergy reliefDiphenhydramine hydrochloride 25 mg/1Bar, ChewableOralCalmCo73282-2520
Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hciAcetaminophen 650 mg/30mL + 3 more ingredientsLiquidOralP & L Development, LLC49580-4160
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride—KitKenvue Brands LLC50580-526
Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate—KitOralCVS HEALTH CORP51316-961
Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrateAspirin 500 mg/1 + 3 more ingredientsTablet, EffervescentOralBayer HealthCare LLC.0280-0021
Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochlorideAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1Tablet, CoatedOralVALU MERCHANDISERS COMPANY63941-220
Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsCapsuleOralChain Drug Consortium, LLC68016-877
Sugar Free Cough Drops Black CherrymentholMenthol 5.8 mg/1PastilleOralCardinal Health 110, Inc.70000-0643
Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hclDextromethorphan hydrobromide 5 mg/5mL + 2 more ingredientsSolutionOralWALMART INC.79903-176
AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromideAcetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mLLiquidOralVIVUNT PHARMA LLC82706-022

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