Broncolito
- Product NDC
- 55758-520
- 11-digit product format
- 557580520
- Labeler code
- 55758
- Product ID
- 55758-520_54ec4c3c-358a-2601-e063-6294a90afcf8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-07-01
- Substance
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 50; 2.5; 5 mg/2.5mL; mg/2.5mL; mg/2.5mL
- 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
- 2027-12-31
- 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
- Broncolito
- Brand name suffix
- Children
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 50 mg/2.5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/2.5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/2.5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1044949 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 509f5b72-9894-ef44-e063-6394a90a6d07 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Kids Daytime Cough and Nighttime Cough combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Genexa Inc. | 4bad39f1-86d4-b8a1-e063-6394a90a7a95 | 2026-02-25 | Warnings | M012 |
| dimaphen dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 67072a38-1ae7-4e59-bfed-71db0d93215d | 2026-02-25 | Warnings | M012 |
| leader tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | b3e3699b-b36c-453c-8f3b-0001388c8e82 | 2026-02-25 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 | 2026-02-25 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Family Dollar Stores, Inc | 1b50b865-3dfc-4b3f-86d5-5e91ca772445 | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Vaproizing | CAMPHOR | H E B | 577fda09-588a-4c2e-ada5-eeda32d1aabe | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Sore Throat Logenzes Sore Throat | BENZOCAINE AND MENTHOL | Major Pharmaceuticals | 11416620-4892-44ba-9780-db27efff6743 | 2026-02-24 | Warnings | M012 |
| Family Wellness SF Honey Lemon Cough Drops | MENTHOL | Family Dollar | 4437853d-1f42-a41d-e063-6294a90aa81e | 2026-02-24 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 64a93715-e7b1-4de1-8099-8ad6c585d517 | 2026-02-24 | Warnings | M012 |
| Cough and Chest Congestion DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 86af74c2-9183-4ee9-ad1e-d88dfc8bf47d | 2026-02-24 | Warnings | M012 |
| Cough DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2026-02-24 | Warnings | M012 |
| Revasol Tussin DM Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Rnv LLC | 4b7fd320-2f39-fa1a-e063-6294a90ada9e | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 47317865-4310-4f07-8815-f3130963307d | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Brands | 42720fa0-fcdd-4614-80b2-16d0ada345b1 | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | cc09a8c5-d173-4261-b838-96e6a16e2ff9 | 2026-02-23 | Warnings | M012 |
| Dimetapp Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 96a1055f-e831-4f4b-8af3-7a41838c194c | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Brands | 1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246 | 2026-02-23 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Better Living Brands, LLC | 0948648c-1c5f-4225-a754-120ca8859f19 | 2026-02-23 | Warnings, Adverse reactions | M012 |
| Revasol Tussin | GUAIFENESIN | Rnv LLC | f66dc593-9023-40e8-9cc3-0380b04b4305 | 2026-02-23 | Warnings | M012 |
| Equate Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 3006971b-784c-43fd-91a6-d96876bbf185 | 2026-02-23 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 55758-520-08 | 55758052008 | 1 BOTTLE, PLASTIC in 1 CARTON (55758-520-08) / 237 mL in 1 BOTTLE, PLASTIC | 2026-07-01 | No | No | Current |