Over-the-counter drug · OTC MONOGRAPH DRUG
Cold plus Flu Severe NDC 63941-263
Acetaminophen 325 mg/1 + 3 more ingredients · Tablet, Coated · Oral · VALU MERCHANDISERS COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63941-263-05 | 63941026305 | 2 BLISTER PACK in 1 CARTON (63941-263-05) / 12 TABLET, COATED in 1 BLISTER PACKMarketed from Apr 14, 2023 |
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 plus Flu Severe
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Active ingredients
- Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1Guaifenesin — 200 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- VALU MERCHANDISERS COMPANYNDC labeler code 63941
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63941-263_45b2c25f-1690-6494-e063-6294a90a91faSPL ID 45b2c25f-1690-6494-e063-6294a90a91faSPL set ID f6401317-0295-14b3-e053-2a95a90acbb4RxCUI 1110988UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- Pharmacologic class
- Expectorant; 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
N463941026305followed by a unit qualifier and the quantityPackage 63941-0263-05. 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 for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough 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.
About NDC 63941-263
- What is NDC 63941-263?
- 63941-263 is the product NDC for Cold plus Flu Severe, Acetaminophen 325 mg/1 + 3 more ingredients tablet, coated, listed with the FDA by VALU MERCHANDISERS COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cold plus Flu Severe (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- VALU MERCHANDISERS COMPANY, NDC labeler code 63941. 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 plus Flu Severe?
- 3 other product NDCs are listed under this name. See all Cold plus Flu Severe NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cold plus Flu Severe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cold plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Tablet, CoatedOral | HYVEE INC | 42507-163 | 42507-0163-05 |
| Cold plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-111 | 83324-0111-24 |
| Cold plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-263 | 68998-0263-05 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cold and Flu HBPacetaminophen, chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-120 |
| Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | WALMART INC. | 79903-417 |
| Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0343 |
| Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-572 |
| SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-450 |
| Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients | LiquidOral | TARGET CORPORATION | 11673-828 |
| Freegells Cough Drops Menthol Cherry 30ctmenthol | Levomenthol 5.8 mg/1 | LozengeOral | RL Albert & Son Inc. | 83002-040 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-173 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Dextrum Laboratories, Inc | 65852-020 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-878 |
| Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HARRIS TEETER | 72036-274 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl | Acetaminophen 1000 mg/30mL + 3 more ingredients | SyrupOral | Haleon US Holdings LLC | 0067-0114 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin | — | Kit | WALMART INC. | 79903-414 |
| Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | MEIJER DISTRIBUTION INC | 79481-6308 |
| Menthol Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Target Corporation Inc. | 82442-001 |
| adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Meijer Distribution Inc | 41250-261 |
| Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Advanced Generic Corporation | 45737-250 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 |
| Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl | — | Kit | L.N.K. International, Inc. | 50844-529 |
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