Over-the-counter drug · OTC MONOGRAPH DRUG
Giltuss Childrens Cough and Cold NDC 58552-131
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride · Dextromethorphan hydrobromide 7.5 mg/2.5mL + 2 more ingredients · Solution · Oral · Gil Pharmaceutical Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58552-131-04 | 5855201310458552013104 | 1 BOTTLE in 1 CARTON (58552-131-04) / 118 mL in 1 BOTTLEMarketed from Nov 7, 2018 |
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)
- Giltuss Childrens Cough and Cold
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Active ingredients
- Dextromethorphan hydrobromide — 7.5 mg/2.5mLGuaifenesin — 150 mg/2.5mLPhenylephrine hydrochloride — 5 mg/2.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Gil Pharmaceutical CorpNDC labeler code 58552
- 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 58552-131_40b823a5-5359-e635-e063-6394a90a4283SPL ID 40b823a5-5359-e635-e063-6394a90a4283SPL set ID 852b77ae-a5ac-3ead-e053-2a91aa0a54bdRxCUI 1251031UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
- 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
N458552013104followed by a unit qualifier and the quantityPackage 58552-0131-04. 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 cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants the intensity of coughing the impulse to cough helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes stuffy nose
Excerpt only. Read the full label for complete information.
About NDC 58552-131
- What is NDC 58552-131?
- 58552-131 is the product NDC for Giltuss Childrens Cough and Cold, Dextromethorphan hydrobromide 7.5 mg/2.5mL + 2 more ingredients solution, listed with the FDA by Gil Pharmaceutical Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Giltuss Childrens Cough and Cold (Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Gil Pharmaceutical Corp, NDC labeler code 58552. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Giltuss Childrens Cough and Cold?
- 1 other product NDC are listed under this name. See all Giltuss Childrens Cough and Cold NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Giltuss Childrens Cough and Cold products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Giltuss Childrens Cough and Colddextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Dextromethorphan hydrobromide 7.5 mg/2.5mL + 2 more ingredients | SolutionOral | Dextrum Laboratories Inc. | 65852-011 | 65852-0011-04 |
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 |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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