BRONCOCHEM
- Product NDC
- 65131-011
- 11-digit product format
- 651310011
- Labeler code
- 65131
- Product ID
- 65131-011_ed1309d2-2a41-4fc7-86b5-5927a1f1c1d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Application
- M
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-21
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 20; 400; 10 mg/10mL; mg/10mL; mg/10mL; mg/10mL
- 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
- BRONCOCHEM
- Brand name suffix
- EXPECTORANT II
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/10mL |
| GUAIFENESIN | 400 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2712155 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65131-011-68 | BRONCOCHEMEXPECTORANT II | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | 1 | |
| 65131-011-68 | BRONCOCHEMEXPECTORANT II | 1 in 1 BOX | SYRUP | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65131-011 | BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] | 1 | Current NDC, 2 package rows | 20250421_1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a.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 |
|---|---|---|---|---|
| 2712155 | acetaminophen 325 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 1 |
| 2712155 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 1 |
| 2712155 | acetaminophen 325 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 1 |
| 2712155 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SY | 1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 65131-011-68 | 65131001168 | 1 BOTTLE, PLASTIC in 1 BOX (65131-011-68) / 120 mL in 1 BOTTLE, PLASTIC | 2025-04-21 | No | No | Current |