Over-the-counter drug · OTC MONOGRAPH DRUG
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN NDC 85722-0002
Dextromethorphan hydrobromide 20 mg/5mL; Guaifenesin 300 mg/5mL · Syrup · Oral · KJD Pharma Private Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)85722-0002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85722-0002Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85722-0002-4 | 85722000204 | 118 mL in 1 BOTTLE (85722-0002-4)Marketed from Feb 1, 2021 | |
| 85722-0002-6 | 85722000206 | 473 mL in 1 BOTTLE (85722-0002-6)Marketed from Feb 1, 2021 | |
| 85722-0002-8 | 85722000208 | 236 mL in 1 BOTTLE (85722-0002-8)Marketed from Feb 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Generic name (nonproprietary)
- dextromethorphan hydrobromide and guaifenesin
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/5mLGuaifenesin — 300 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- KJD Pharma Private LimitedNDC labeler code 85722
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85722-0002_9cb5da4e-9175-4339-83da-fc22448b2e80SPL ID 9cb5da4e-9175-4339-83da-fc22448b2e80SPL set ID b109249a-a0be-41bd-b6ce-ef621b588ddcRxCUI 1117394UNII 9D2RTI9KYH, 495W7451VQ
- Pharmacologic class
- Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
N485722000204followed by a unit qualifier and the quantityPackage 85722-0002-04. 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 as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Excerpt only. Read the full label for complete information.
About NDC 85722-0002
- What is NDC 85722-0002?
- 85722-0002 is the product NDC for DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN, Dextromethorphan hydrobromide 20 mg/5mL; Guaifenesin 300 mg/5mL syrup, listed with the FDA by KJD Pharma Private Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN.
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- KJD Pharma Private Limited, NDC labeler code 85722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN?
- 8 other product NDCs are listed under this name. See all DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | OPMX LLC | 69729-812 | 69729-0812-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 20 mg/5mL; Guaifenesin 300 mg/5mL | SyrupOral | OPMX LLC | 69729-020 | 69729-0020-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | OPMX LLC | 69729-035 | 69729-0035-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | OPMX LLC | 69729-036 | 69729-0036-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 20 mg/5mL; Guaifenesin 300 mg/5mL | SyrupOral | OPMX LLC | 69729-040 | 69729-0040-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 20 mg/5mL; Guaifenesin 300 mg/5mL | SyrupOral | OPMX LLC | 69729-062 | 69729-0062-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | OPMX LLC | 69729-069 | 69729-0069-04 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SyrupOral | KJD Pharma Private Limited | 85722-0001 | 85722-0001-0485722-0001-0685722-0001-08 |
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 |
|---|---|---|---|---|
| Cold and Flu HBPacetaminophen, chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-120 |
| Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | WALMART INC. | 79903-417 |
| Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0343 |
| Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-572 |
| SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-450 |
| Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients | LiquidOral | TARGET CORPORATION | 11673-828 |
| Freegells Cough Drops Menthol Cherry 30ctmenthol | Levomenthol 5.8 mg/1 | LozengeOral | RL Albert & Son Inc. | 83002-040 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-173 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Dextrum Laboratories, Inc | 65852-020 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-878 |
| Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HARRIS TEETER | 72036-274 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl | Acetaminophen 1000 mg/30mL + 3 more ingredients | SyrupOral | Haleon US Holdings LLC | 0067-0114 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin | — | Kit | WALMART INC. | 79903-414 |
| Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | MEIJER DISTRIBUTION INC | 79481-6308 |
| Menthol Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Target Corporation Inc. | 82442-001 |
| adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Meijer Distribution Inc | 41250-261 |
| Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Advanced Generic Corporation | 45737-250 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 |
| Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl | — | Kit | L.N.K. International, Inc. | 50844-529 |
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