Over-the-counter drug · OTC MONOGRAPH DRUG
CETAFEN COUGH and COLD NDC 50332-0141
acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , · Guaifenesin 100 mg/1 + 3 more ingredients · Tablet, Film coated · Oral · HART Health
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50332-0141-3 | 5033201410350332014103 | 20 PACKET in 1 BAG (50332-0141-3) / 2 TABLET, FILM COATED in 1 PACKETMarketed from Jan 9, 2023 | |
| 50332-0141-4 | 5033201410450332014104 | 40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKETMarketed from Jan 9, 2023 | |
| 50332-0141-7 | 5033201410750332014107 | 100 PACKET in 1 BOX (50332-0141-7) / 2 TABLET, FILM COATED in 1 PACKETMarketed from Jan 9, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- CETAFEN COUGH and COLD
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, ,
- Active ingredients
- Guaifenesin — 100 mg/1Phenylephrine hydrochloride — 5 mg/1Acetaminophen — 325 mg/1Dextromethorphan hydrobromide — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- HART HealthNDC labeler code 50332
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M
- Marketing start
- Listing expires
- 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 50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042SPL ID 866ea7b4-cf9b-4001-a533-12b8f562e042SPL set ID 44da0d8c-4a12-4122-99da-781e2809e1a8RxCUI 1098435UNII 495W7451VQ, 04JA59TNSJ, 362O9ITL9D, 9D2RTI9KYH
- 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
N450332014103followed by a unit qualifier and the quantityPackage 50332-0141-03. 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 cold and flu symptoms cough sore throat headache minor aches and pains nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and bronchial secretions to coughs more productive Temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 50332-0141
- What is NDC 50332-0141?
- 50332-0141 is the product NDC for CETAFEN COUGH and COLD, Guaifenesin 100 mg/1 + 3 more ingredients tablet, film coated, listed with the FDA by HART Health. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CETAFEN COUGH and COLD (Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,).
- What is the active ingredient?
- Guaifenesin, Phenylephrine hydrochloride, Acetaminophen, Dextromethorphan hydrobromide.
- Who is the labeler?
- HART Health, NDC labeler code 50332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CETAFEN COUGH and COLD?
- 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
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 |
|---|---|---|---|---|
| Broncochem Maximum Cough Kidsdextromethorphan hbr-guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL; Guaifenesin 100 mg/15mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-180 |
| Hydrocortisonehydrocortisone cream | Hydrocortisone acetate 10 mg/g | CreamTopical | HART Health | 50332-0092 |
| First Aid and Burnbenzalkonium chloride, lidocaine | Benzalkonium chloride .13 g/100g; Lidocaine .5 g/100g | CreamTopical | HART Health | 50332-0091 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0093 |
| Hand Sanitizerantiseptic gel | Alcohol 62 g/100g | GelTopical | HART Health | 50332-0094 |
| Tribioticbacitracin zinc, neomycin sulfate, polymyxin b sulfate | Bacitracin zinc 400 [iU]/g + 2 more ingredients | OintmentTopical | HART Health | 50332-0095 |
| Therastatcherry cough drops | Menthol 5.8 mg/1 | LozengeOral | HART Health | 50332-0137 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | HART Health | 50332-0139 |
| Hand Sanitizer Solution 101benzalkonium chloride | Benzalkonium chloride 13 kg/100kg | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-224 |
| Histaprindiphenhydramine | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | NorMed | 50332-0150 |
| IT Cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep Deep Honey Deep Bronze Neutral Deep Deep Mocha Tan Cool Rich Cool Deep Cool Neutral Richhomosalate, octisalate and octocrylene | Homosalate 100 mg/mL + 2 more ingredients | CreamTopical | LOreal USA Products Inc | 49967-904 |
| Cetafenacetaminophen | Acetaminophen 325 mg/1 | TabletOral | HART Health | 50332-0148 |
| MG DermaClean | Benzalkonium chloride .13 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-014 |
| MG FoamSan 70ethyl alcohol | Alcohol .7 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-223 |
| Cetafen Extraacetaminophen | Acetaminophen 500 mg/1 | TabletOral | HART Health | 50332-0149 |
| MG DermaGel 62ethyl alcohol | Alcohol .62 L/L | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-326 |
| Cetirzacetirizine hcl | Cetirizine hydrochloride 10 mg/1 | TabletOral | HART Health | 50332-0154 |
| MG DermaSan | Benzalkonium chloride .1 g/100g | LiquidTopical | Morgan Gallacher Inc. | 50241-259 |
| Nutraloxcalcium carbonate | Calcium carbonate 420 mg/1 | Tablet, ChewableOral | HART Health | 50332-0151 |
| MG DermaWashbenzalkonium chloride | Benzalkonium chloride 13 kg/100kg | LiquidTopical | Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. | 50241-302 |
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