CETAFEN COUGH and COLD
- Product NDC
- 50332-0141
- 11-digit product format
- 503320141
- Labeler code
- 50332
- Product ID
- 50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HART Health
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-09
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 100; 5; 325; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CETAFEN COUGH and COLD
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 100 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1098435 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44da0d8c-4a12-4122-99da-781e2809e1a8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0141 | CETAFEN COUGH AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,) TABLET, FILM COATED [HART HEALTH] | 3 | Current NDC | 20241206_44da0d8c-4a12-4122-99da-781e2809e1a8.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 396903dc-ae2d-4bf4-b1fd-0017b84abef9 | 2024-02-28 | Warnings | M |
| MAX relief junior | ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | 44730cbd-5b98-49bd-b3b8-6fecb0ccd153 | 2024-02-28 | Warnings | M |
| HYDROCORTISONE | HYDROCORTISONE ACETATE | HART Health | 779f945f-ab69-40de-8d86-ab76debc5c7c | 2024-02-16 | Warnings | M |
| First Aid and Burn | BENZALKONIUM CHLORIDE, LIDOCAINE | HART Health | f5746bba-9d7f-4691-b466-14985473bf14 | 2024-02-16 | Warnings | M |
| IBUPROFEN | IBUPROFEN | HART Health | 1c1374e1-890f-48ab-8f93-e84da9d5bf84 | 2024-01-25 | Warnings | M |
| Hand Sanitizer | ANTISEPTIC GEL | HART Health | f07daf29-d0db-4cf8-8baf-d175c2b2ef50 | 2024-01-25 | Warnings | M |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | HART Health | 0346a322-8f6e-405a-8d17-8bc6ce5105a3 | 2024-01-24 | Warnings | M |
| Alcohol | ISOPROPYL ALCOHOL | NorMed | 441b915a-287f-4734-b4d9-730b3d95e04c | 2024-01-24 | Warnings | M |
| Sooth-a-Sting | BENZOCAINE | HART Health | bd7229b6-813a-4149-bfe2-fe682f270ff4 | 2024-01-18 | Warnings | M |
| First Aid | BENZALKONIUM CHLORIDE, BENZOCAINE | HART Health | a6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a | 2024-01-18 | Warnings | M |
| TRIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | HART Health | d8f175f9-f526-4c73-a171-49309ca16cb0 | 2024-01-18 | Warnings, Adverse reactions | M |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1098435 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 44da0d8c-4a12-4122-99da-781e2809e1a8 | 4 |
| 1098435 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 44da0d8c-4a12-4122-99da-781e2809e1a8 | 4 |
| 1098435 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 44da0d8c-4a12-4122-99da-781e2809e1a8 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50332-0141-3 | 50332014103 | 20 PACKET in 1 BAG (50332-0141-3) / 2 TABLET, FILM COATED in 1 PACKET | 20 packet | 2023-01-09 | No | No | Current |
| 50332-0141-4 | 50332014104 | 40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKET | 40 packet | 2023-01-09 | No | No | Current |
| 50332-0141-7 | 50332014107 | 100 PACKET in 1 BOX (50332-0141-7) / 2 TABLET, FILM COATED in 1 PACKET | 100 packet | 2023-01-09 | No | No | Current |