NDC codes

FDA NDC Directory
Product NDC (as listed)55758-520Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55758-0520Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55758-520-08557580520081 BOTTLE, PLASTIC in 1 CARTON (55758-520-08) / 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)
Broncolito ChildrenSuffix: Children
Generic name (nonproprietary)
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Active ingredients
Guaifenesin — 50 mg/2.5mLPhenylephrine hydrochloride — 2.5 mg/2.5mLDextromethorphan hydrobromide — 5 mg/2.5mL
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 55758-520_54ec4c3c-358a-2601-e063-6294a90afcf8SPL ID 54ec4c3c-358a-2601-e063-6294a90afcf8SPL set ID 509f5b72-9894-ef44-e063-6394a90a6d07RxCUI 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

N455758052008 followed by a unit qualifier and the quantity

Package 55758-0520-08. 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.

Full label on DailyMed (opens in a new tab)

About NDC 55758-520

What is NDC 55758-520?
55758-520 is the product NDC for Broncolito Children, Guaifenesin 50 mg/2.5mL + 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?
Broncolito Children (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 Broncolito Children?
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.

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
equate allergy reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1TabletOralWALMART INC.79903-297
Nighttime Severe Cold and Fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hclDoxylamine succinate 12.5 mg/30mL + 3 more ingredientsLiquidOralGrocery Outlet, Inc.85828-775
Complete Cold Reliefacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralBelmora LLC27854-299
Allergy Reliefdiphenhydramine hcl 25 mgDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralLil' Drug Store Products, Inc.29485-9285
Sinus Relief Daytime Nighttimeacetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl—KitKroger Company30142-616
nasal decongestantoxymetazoline hclOxymetazoline hydrochloride .05 g/100mLSprayNasalA-S Medication Solutions50090-5281
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola Ag54305-342
Geri-Tussin DMdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralGeri-Care Pharmaceuticals, Corp57896-661
Childrens Cough and Coldchlorpheniramine maleate, dextrometrorphan hbrChlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 15 mg/10mLLiquidOralFAMILY DOLLAR SERVICES INC55319-754
Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hclAcetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1TabletOralDOLGENCORP, LLC55910-925
Giltuss Sinus and Chest Congestionguaifenesin, phenylephrine hclGuaifenesin 388 mg/1; Phenylephrine hydrochloride 10 mg/1TabletOralGil Pharmaceutical Corp58552-332
Robitussin Day and Night Cough Relief Value Packdextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate—KitHaleon US Holdings LLC0031-2099
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gelsalka-seltzer plus severe cough mucus and congestionPhenylephrine hydrochloride 5 mg/1 + 3 more ingredientsCapsule, Liquid filledOralBayer HealthCare LLC.0280-0505
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nosedextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochlorideDextromethorphan hydrobromide 5 mg/5mL + 2 more ingredientsSolutionOralReckitt Benckiser LLC63824-956
Major Nasal Decongestantoxymetazoline hydrochlorideOxymetazoline hydrochloride .5 mg/mLSprayNasalNuCare Pharmaceuticals, Inc.68071-3858
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1Tablet, Film coatedOralWalgreen Company0363-1799
nighttime severe cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralWalgreen Company0363-2029
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 50 mg/1TabletOralBIONPHARMA INC.69452-445
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitCVS Pharmacy69842-820

Showing 20 of 40.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in