Over-the-counter drug · OTC MONOGRAPH FINAL
Mucus Relief Cough and Congestion DM (Guaifenesin and dextromethorphan hbr) NDC 54738-985
Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 · Tablet · Oral · Richmond Pharmaceuticals, Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)54738-985Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54738-0985Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54738-985-30 | 5473809853054738098530 | 30 TABLET in 1 BOTTLE (54738-985-30)Marketed from Apr 1, 2016 | |
| 54738-985-60 | 5473809856054738098560 | 60 TABLET in 1 BOTTLE (54738-985-60)Marketed from Apr 1, 2016 |
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)
- Mucus Relief Cough and Congestion DM
- Generic name (nonproprietary)
- guaifenesin and dextromethorphan hbr
- Active ingredients
- Dextromethorphan hydrobromide — 20 mg/1Guaifenesin — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Richmond Pharmaceuticals, IncNDC labeler code 54738
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (final)Application part341
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 54738-985_5cc409a8-23e1-738f-e053-2a91aa0ac0d5SPL ID 5cc409a8-23e1-738f-e053-2a91aa0ac0d5SPL set ID 59b00858-e5c9-420a-bc7e-46953722cde6RxCUI 1147685UNII 9D2RTI9KYH, 495W7451VQUPC 0054738985306
- Pharmacologic class
- 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
N454738098530followed by a unit qualifier and the quantityPackage 54738-0985-30. 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 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Excerpt only. Read the full label for complete information.
About NDC 54738-985
- What is NDC 54738-985?
- 54738-985 is the product NDC for Mucus Relief Cough and Congestion DM, Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 tablet, listed with the FDA by Richmond Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief Cough and Congestion DM (Guaifenesin and Dextromethorphan HBr).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- Richmond Pharmaceuticals, Inc, NDC labeler code 54738. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mucus Relief Cough and Congestion DM?
- 2 other product NDCs are listed under this name. See all Mucus Relief Cough and Congestion DM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mucus Relief Cough and Congestion DM products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-150 | 17714-0150-60 |
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1928 | 71335-1928-0171335-1928-0271335-1928-03 |
Other NDCs under part341
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 |
|---|---|---|---|---|
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-021 |
| Broncochem Allergy Controlcholpheniramine maleate-phenylephrine hcl | Chlorpheniramine maleate 4 mg/10mL; Phenylephrine hydrochloride 10 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-098 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-023 |
| Sugar Free Cherry Cough Dropsmenthol | Menthol 5.8 1/1 | LozengeOral | Army & Air Force Exchange Service | 55301-038 |
| Best Choice Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Valu Merchandiser Company | 63941-873 |
| CVS Health Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 69842-753 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7991 |
| Assured Vaporizing Chest Rubcamphor and eucalyptus oil and menthol | Camphor (Synthetic) 4.7 g/100g + 2 more ingredients | OintmentTopical | Greenbrier International, Inc. | 33992-7992 |
| Childrens Multi-symptom Cold Daytimedextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 79903-270 |
| Broncochem Maximum Coughdextromethorphan hbr-gyaifenesin | Dextromethorphan hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-091 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Advance Pharmaceutical Inc. | 17714-020 |
| Anti Allergychlorpheniramine maleate | Chlorpheniramine maleate 4 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-016 |
| Broncochem Kids Cold And Fluacetaminophen-phenylephrine hcl-guaifenesin | Acetaminophen 325 mg/10mL + 2 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-054 |
| Broncochem Kids Allergy Controlchlorpheniramine maleate-dextromethrophan hbr | Chlorpheniramine maleate 2 mg/10mL; Dextromethorphan hydrobromide 10 mg/10mL | SyrupOral | LABORATORIO MAGANCEHM INTERNATIONAL SRL | 65131-418 |
| Childrens Multi-symptom Cold and Fever Liquidacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/10mL + 3 more ingredients | LiquidOral | Wal-Mart Stores, Inc. | 49035-772 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-152 |
| Acetaminophen PM | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-133 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-135 |
| Mucus Relief Cough and Congestion DMguaifenesin and dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-150 |
| Effervescent Cold Reliefaspirin, chlorpheniramine maleate, phenylephrine bitartrate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Discount Drug Mart | 53943-873 |
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