NDC 50580-140OTC monographFDA OTC MONOGRAPH DRUG · M012

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day

Active substance: Acetaminophen and dextromethorphan hydrobromide

FDA labeler: Kenvue Brands LLC

3 formulations • 3 package configurations
All 6 registered NDCs — click to copy
In one line

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day (Acetaminophen and dextromethorphan hydrobromide) NDC 50580-140 converts to 50580-0140-08 for billing and bills under J0131 at 10 mg = 1 Unit.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence
Listing: 50580-140 Verified
1. Initial Approval
2025
First U.S. FDA clearance for Acetaminophen and dextromethorphan hydrobromide
2. FDA Application
M012
Regulatory pathway: OTC MONOGRAPH DRUG
3. Market Entry Date
Jun 6, 2025
First commercial NDC distribution & launch date
4. Regulatory Status
Active Commercial Listing
Registration valid through Dec 31, 2026
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
J0131
Injection, acetaminophen, 10 mg
Billable unit: 10 mg = 1 Unit
11-digit HIPAA NDC
50580-0140-08
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
99213 / Pharmacy
Oral self-administered medication / Office Visit or Pharmacy Claim
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: ML

Interactive Unit Multiplier Calculator

J0131

Calculate the exact number of billable HCPCS units to report on CMS-1500 / 837P claims based on the patient dose and single-dose vial waste.

MG
Units to report on claim:
10 Units
Based on 10 mg = 1 billable unit (10.0 exact)
Box 24 / HCPCS Quantity Formatted Line:J0131 UN10 (N45058014008)
Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.
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All registered strengths & packaging

Every registered strength and package for Extra Strength TYLENOL Severe Cough Plus Sore Throat Day, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
1000 mg/30mL, 30 mg/30mL50580-140-0850580-14050580-0140-08240 mL in 1 BOTTLE (50580-140-08)
15 mg/1, 500 mg/150580-446-0150580-44650580-0446-012 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
Outer kit carton50580-551-0150580-55150580-0551-011 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ temporarily reduces fever Uses ■ temporarily relieves these common cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough ■ sneezing and runny nose ■ temporarily reduces fever
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor Directions do not take more than directed (see overdose warning ) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ■ if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ■ liver disease ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dose ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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