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 |
|---|---|---|---|---|---|---|
| Suphedrine PE Sinus Congestion Non-Drowsy | PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | b9122fd0-0bed-4302-9bbe-cd6a46d29818 | 2026-01-12 | Warnings | M012 |
| Sinu-Phen Plus Sinus Pain and Pressure | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Wildman Business Group | c66e0b52-5531-4a84-ae90-8a26d27df1ec | 2026-01-12 | Warnings | M012 |
| SU PHEDRINE PE SINUS CONGESTION | PHENYLEPHRINE HCL | Salado Sales, Inc. | ba075ff7-4e26-4856-8335-0c7dd4e198ea | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | bab078bb-f6b0-4394-84de-92b2c582b5da | 2026-01-12 | Warnings | M012 |
| Nasal Decongestant PE Non-Drowsy Maximum Strength | PHENYLEPHRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d | 2026-01-12 | Warnings | M012 |
| CVS Health Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | CVS Pharmacy | 022c3083-c611-47d0-aa93-d6c7612e7a47 | 2026-01-11 | Warnings | M012 |
| CVS Health Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | CVS Pharmacy | bf73d15a-9d68-42fa-bfee-d25748215f97 | 2026-01-11 | Warnings | M012 |
| GUAIFENESIN 400MG CAPLETS | GUAIFENESIN | Gendose Pharmaceuticals, LLC | e7b82ec7-ef23-50c1-e053-2a95a90a662f | 2026-01-10 | Warnings | M012 |
| Daytime Cold and Flu | DAYTIME COLD AND FLU | Allegiant Health | 69ed2da0-16b2-49eb-91b4-cc5cf328c817 | 2026-01-09 | Warnings | M012 |
| HyVee Cough Drops Original Herb | MENTHOL | HY-VEE, INC | 47f81e54-0ce4-439d-e063-6294a90a2abe | 2026-01-09 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | A-S Medication Solutions | a5809774-ed52-4f54-b48e-888631e0223d | 2026-01-09 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5767f546-a751-4583-a8b7-971175c27ef0 | 2026-01-09 | Warnings | M012 |
| Thompson Cough and Cold Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, , | Thompson | e77725b1-15da-35bd-e053-2a95a90ad6ba | 2026-01-08 | Warnings | M012 |
| Mucosan Childrens Multi-Symptom Grape | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 266c8cce-cdf9-557d-e063-6394a90a9bc3 | 2026-01-08 | Warnings | M012 |
| Mucosan Multi-Symptom Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Menper Distributors, Inc. | 2669c620-ab70-abaa-e063-6394a90a58e7 | 2026-01-08 | Warnings | M012 |
| Mucosan Multi-Symptom Cherry | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 26b8c06d-4a72-3979-e063-6394a90a96d7 | 2026-01-08 | Warnings | M012 |
| Mucosan Max with Acetaminophen | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE | Menper Distributors, Inc. | 26a4861b-5d8e-9ec6-e063-6394a90af577 | 2026-01-08 | Warnings | M012 |
| Mucosan Severe Multi-Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Menper Distributors, Inc. | 26a69342-f65f-cb46-e063-6394a90ade10 | 2026-01-08 | Warnings | M012 |
| HyVee Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | e4e15c13-f583-4484-a5f0-f04c39c7b7c9 | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy | ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a355d987-77ce-9e32-e053-2995a90a6431 | 2026-01-08 | 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 |