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 |
|---|---|---|---|---|---|---|
| Menthol Pain Relieving Cream with Menthol 10% | MENTHOL 10% CREAM | ONE2ZEE LIMITED LIABILITY COMPANY | ae09e93f-3988-4477-ae53-b2f3df9769fb | 2025-05-05 | Warnings | M |
| Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ENGLEWOOD LAB, INC. | edf07b7f-46fb-4915-b2ea-83d852617f60 | 2025-04-10 | Warnings | M |
| BRONCOCHEM KIDS COLD AND FLU | ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b6559fb9-2dea-49c0-a274-3e77741a0ffd | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH | DEXTROMETHORPHAN HBR-GYAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | deecdb72-4cdb-4d6f-972f-a425a91afa5a | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH NIGHT | DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | dffdfa2c-a52e-4606-9b07-c8993e499f09 | 2025-03-23 | Warnings | M |
| BRONCOCHEM EXPECTORANT II | ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 2025-03-23 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH KIDS | DEXTROMETHORPHAN HBR-GUAIFENESIN | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b0fd2f2f-5cc4-4813-8f99-c78fbe898656 | 2025-03-13 | Warnings | M |
| Menthol Pain Relief Gel Patch | MENTHOL PAIN RELIEF GEL PATCH | ONE2ZEE LIMITED LIABILITY COMPANY | eab185d6-2a54-489d-8114-fe8088624ba4 | 2025-03-04 | Warnings | M |
| Lidocaine 4% Pain Relief Gel Patch | LIDOCAINE 4% PAIN RELIEF GEL PATCH | ONE2ZEE LIMITED LIABILITY COMPANY | 8e5a4ef4-b928-44b3-842c-92f1531af75b | 2025-03-03 | Warnings | M |
| gas relief | SIMETHICONE | Strategic Sourcing Services LLC | 23005295-c5f2-4a76-8431-4a9b8d817d4d | 2025-01-03 | Warnings | M |
| Foster and Thrive infants Gas relief | SIMETHICONE | Strategic Sourcing Services LLC | 824c9dff-0a26-4710-a25b-39df631d6fa6 | 2024-12-13 | Warnings | M |
| BRONCOCHEM COLD AND FLU TEA | ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | b7d3f54e-59ef-4b85-a88d-b053058dc1f6 | 2024-12-12 | Warnings | M |
| HYSAN PAIN RELIEVER | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | bad73234-c204-40a8-8176-45c75ae500c8 | 2024-10-07 | Warnings | M |
| HYSAN ANALGESIC | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | 99a13b0a-1d77-479e-ba99-2cfa638de339 | 2024-10-04 | Warnings | M |
| HYSAN HUO LU MEDICATED | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | fe9eeaff-fcbf-4287-9f17-bcf1822bf35b | 2024-10-04 | Warnings | M |
| HYSAN HUA TUO MEDICATED | METHYL SALICYLATE | HYSAN PHARMACEUTICAL CO LTD | b84c4d33-5a77-46e0-b04e-32f73967bd1c | 2024-10-04 | Warnings | M |
| HYSAN HUA TUO HUO LU | METHYL SALICYLATE, CAMPHOR (SYNTHETIC) | HYSAN PHARMACEUTICAL CO LTD | cd2288c4-9909-43c1-91da-b15545b09788 | 2024-10-04 | Warnings | M |
| CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-free | ALUMINUM CHLOROHYDRATE | Laboratoires Clarins | 412116a1-f9af-4c03-85e0-aad5738dd797 | 2024-08-05 | Warnings | M |
| BRONCOCHEM MAXIMUM COUGH NIGHT | DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 1a3ed214-e09b-4266-b68b-39e7c3127d26 | 2024-04-22 | Warnings | M |
| CLARUS Antifungal | TOLNAFTATE | Clinical Therapeutic Solutions | 835c3c23-fc3c-404e-8e87-5a0176126730 | 2024-02-28 | Warnings | 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 |