Over-the-counter drug · OTC MONOGRAPH DRUG
Giltuss Cough and Cold NDC 65852-012
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride · Dextromethorphan hydrobromide 15 mg/5mL + 2 more ingredients · Solution · Oral · Dextrum Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65852-012-04 | 6585200120465852001204 | 1 BOTTLE, PLASTIC in 1 CARTON (65852-012-04) / 113 mL in 1 BOTTLE, PLASTICMarketed from Oct 2, 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 Cough and Cold
- Generic name (nonproprietary)
- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/5mLPhenylephrine hydrochloride — 10 mg/5mLGuaifenesin — 300 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Dextrum Laboratories Inc.NDC labeler code 65852
- 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 65852-012_3f12ee8f-d1c7-d73a-e063-6394a90a9199SPL ID 3f12ee8f-d1c7-d73a-e063-6394a90a9199SPL set ID 3f12ee8f-d1c6-d73a-e063-6394a90a9199RxCUI 1251031UNII 9D2RTI9KYH, 04JA59TNSJ, 495W7451VQ
- 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
N465852001204followed by a unit qualifier and the quantityPackage 65852-0012-04. 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)
Indication and usage section Indication and usage section Do not exceed recommended dosage, do not take more than 6 doses in any 24 hours period, keep dosing cup for use with this product, ml=mililiters. Adults and children 12 years & over 5 ml every 4 hours children 6 to under 12 years age 2.5 ml every 4 hours children 4 to 6 years of age 1.25 ml every 4 hours children under 6 years of age Consult a doctor indication an user
Excerpt only. Read the full label for complete information.
About NDC 65852-012
- What is NDC 65852-012?
- 65852-012 is the product NDC for Giltuss Cough and Cold, Dextromethorphan hydrobromide 15 mg/5mL + 2 more ingredients solution, listed with the FDA by Dextrum Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Giltuss Cough and Cold (Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Guaifenesin.
- Who is the labeler?
- Dextrum Laboratories Inc., NDC labeler code 65852. 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 Cough and Cold?
- 2 other product NDCs are listed under this name. See all Giltuss 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 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 Cough and Colddextromethorphan hbr, guaifenesin, phenylephrine hcl | Guaifenesin 388 mg/1 + 2 more ingredients | TabletOral | Gil Pharmaceutical Corp | 58552-331 | 58552-0331-20 |
| Giltuss Cough and Colddextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Dextromethorphan hydrobromide 15 mg/5mL + 2 more ingredients | SolutionOral | Gil Pharmaceutical Corp | 58552-130 | 58552-0130-04 |
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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