TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night (Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate) NDC 50580-141 converts to 50580-0141-03 for billing and bills under J0131 at 10 mg = 1 Unit.
FDA Approval & Market Entry Timeline
Official openFDA & DailyMed regulatory registration sequence
Listing: 50580-141 Verified
1. Initial Approval
2025
First U.S. FDA clearance for Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
2. FDA Application
M012
Regulatory pathway: OTC MONOGRAPH DRUG
3. Market Entry Date
Jun 30, 2025
First commercial NDC distribution & launch date
4. Regulatory Status
Active Commercial Listing
Registration valid through Dec 31, 2027
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
50580-0141-03
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: UN
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.
Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.
Complete drug registry
All registered strengths & packaging
Every registered strength and package for TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night, with 10-digit and 11-digit NDC formats
Formulation / role
Package NDC
Product NDC
11-digit HIPAA
Packaging detail
Copy
Outer kit carton
50580-141-03
50580-141
50580-0141-03
3 KIT in 1 PACKAGE (50580-141-03) / 1 KIT in 1 KIT * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED 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 ■ runny nose and sneezing ■ temporarily reduces fever
Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 capsules every 4 hours while symptoms last ■ do not take more than 8 capsules in 24 hours Children 4 to under 12 years ask a doctor Children under 4 years do not use
Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 capsules every 6 hours while symptoms last ■ do not take more than 8 capsules in 24 hours Children 4 to under 12 years ask a doctor Children under 4 years do not use
Warnings 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.
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.
Warnings 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.
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.