Over-the-counter drug · OTC MONOGRAPH DRUG
Broncomiel Adults NDC 55758-512
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride · Guaifenesin 200 mg/10mL + 2 more ingredients · Syrup · Oral · Pharmadel LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55758-512-09 | 55758051209 | 1 BOTTLE, PLASTIC in 1 CARTON (55758-512-09) / 237 mL in 1 BOTTLE, PLASTICMarketed from Jul 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Broncomiel AdultsSuffix: Adults
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Active ingredients
- Guaifenesin — 200 mg/10mLPhenylephrine hydrochloride — 10 mg/10mLDextromethorphan hydrobromide — 20 mg/10mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Pharmadel LLCNDC labeler code 55758
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55758-512_509f6246-1393-fa9d-e063-6394a90a3681SPL ID 509f6246-1393-fa9d-e063-6394a90a3681SPL set ID 509c61d3-ae16-be5c-e063-6294a90a68daRxCUI 1044949UNII 495W7451VQ, 04JA59TNSJ, 9D2RTI9KYH
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455758051209followed by a unit qualifier and the quantityPackage 55758-0512-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Temporarily relieves common cold symptoms: stuffy nose nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Excerpt only. Read the full label for complete information.
About NDC 55758-512
- What is NDC 55758-512?
- 55758-512 is the product NDC for Broncomiel Adults, Guaifenesin 200 mg/10mL + 2 more ingredients syrup, listed with the FDA by Pharmadel LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Broncomiel Adults (Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride).
- What is the active ingredient?
- Guaifenesin, Phenylephrine hydrochloride, Dextromethorphan hydrobromide.
- Who is the labeler?
- Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Broncomiel Adults?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 12 Hour Nasal Decongestant Extra Moisturizingnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-377 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | Sheffield Pharmaceuticals LLC | 11527-140 |
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate solution | Dextromethorphan hydrobromide 30 mg/30mL + 2 more ingredients | SolutionOral | Lil' Drug Store products, Inc. | 66715-6416 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| 4 Way Fast Actingphenylephrine hydrochloride | Phenylephrine hydrochloride 10 mg/mL | SprayNasal | Haleon US Holdings LLC | 0067-2086 |
| 7 Select Maximum Strengthdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | 7-ELEVEN | 10202-740 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Health Pharma USA LLC | 71679-101 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgacetaminophen, dextromethorphan hbr and phenylephrine hcl | Phenylephrine hydrochloride 5 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0188 |
| Acetaminophen and Diphenhydramine citrate | Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 | TabletOral | InvaTech Pharma Solutions LLC | 57631-010 |
| Acetaminophen PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | United Natural Foods, Inc. dba UNFI | 41163-228 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | — | KitOral | CVS Pharmacy, Inc | 51316-984 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-122 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | Acetaminophen 500 mg/1 + 2 more ingredients | TabletOral | OPMX LLC | 69729-322 |
| Acetaminophen, Dextromethorphan HBr | Acetaminophen 325 mg/1; Dextromethorphan hydrobromide 10 mg/1 | Capsule, Liquid filledOral | NUVICARE LLC | 84324-036 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | Guaifenesin 200 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0184 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0185 |
| Acetaminophen, Dextromethorphan HBr, Chlorpheniramine Maleate | — | KitOral | CVS Pharmacy, Inc | 51316-609 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | Phenylephrine hydrochloride 5 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-628 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Softgel Healthcare Private Limited | 35916-0154 |
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