Over-the-counter drug · ANDA
Mucus Relief DM (Guaifenesin, dextromethorphan hbr) NDC 55319-734
Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 · Tablet, Extended release · Oral · Family Dollar (FAMILY WELLNESS)
NDC codes
FDA NDC DirectoryProduct NDC (as listed)55319-734Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0734Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55319-734-07 | 5531907340755319073407 | 7 BLISTER PACK in 1 CARTON (55319-734-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jul 1, 2023 |
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 DM
- Generic name (nonproprietary)
- guaifenesin, dextromethorphan hbr
- Active ingredients
- Dextromethorphan hydrobromide — 60 mg/1Guaifenesin — 1200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Family Dollar (FAMILY WELLNESS)NDC labeler code 55319
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209692
- 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 55319-734_c81bf0ff-96be-4698-b244-f6f0d4df00f9SPL ID c81bf0ff-96be-4698-b244-f6f0d4df00f9SPL set ID b60d1cc6-086c-4483-a101-c5f8d6000969RxCUI 1099074UNII 9D2RTI9KYH, 495W7451VQUPC 0032251920837
- 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
N455319073407followed by a unit qualifier and the quantityPackage 55319-0734-07. 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 55319-734
- What is NDC 55319-734?
- 55319-734 is the product NDC for Mucus Relief DM, Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 tablet, extended release, listed with the FDA by Family Dollar (FAMILY WELLNESS). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mucus Relief DM (Guaifenesin, Dextromethorphan HBr).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Guaifenesin.
- Who is the labeler?
- Family Dollar (FAMILY WELLNESS), NDC labeler code 55319. 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 DM?
- 41 other product NDCs are listed under this name. See all Mucus Relief 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 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 DMdextromethorphan hbr 20mg guaifenesin 400mg | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | NUVICARE LLC | 84324-035 | 84324-0035-01 |
| Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-671 | 51316-0671-5551316-0671-66 |
| Mucus Relief DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Chain Drug Marketing Association, Inc. | 83324-323 | 83324-0323-06 |
| Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-858 | 51316-0858-0151316-0858-78 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-741 | 55319-0741-14 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Advanced Rx LLC | 80513-407 | 80513-0407-09 |
| Mucus Relief DMdextromethorphan hbr 20mg guaifenesin 400mg | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-027 | 72090-0027-01 |
| Mucus Relief DMdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Cardinal Health 110, LLC. DBA Leader | 70000-0707 | 70000-0707-01 |
| Mucus Relief DMguaifenesin and dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Harris Teeter | 72036-012 | 72036-0012-20 |
| Mucus Relief DMguaifenesin dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-137 | 83324-0137-14 |
Other NDCs under ANDA 209692
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 |
|---|---|---|---|---|
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-038 |
| Guaifenesin and Dextromethorphan HBr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-039 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Rite Aid Corporation | 11822-0733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-730 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | H E B | 37808-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | H E B | 37808-834 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-741 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | P & L Development, LLC | 59726-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Best Choice (Valu Merchandisers Company) | 63941-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | WinCo Foods, LLC | 67091-344 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1049 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Strategic Sourcing Services LLC | 70677-1050 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-733 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | TabletOral | Care One (Retail Business Services, LLC.) | 72476-734 |
| Mucus Relief DMguaifenesin, dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | FSA Store Inc. (Caring Mills) | 81522-734 |
| Mucus Relief DMguaifenesin dextromethorphan hbr | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-137 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | TabletOral | Walgreens | 0363-0733 |
| Mucus Relief DM Extended Release Capletsguaifenesin, dextromethorphan hbr | Guaifenesin 600 mg/1; Dextromethorphan hydrobromide 30 mg/1 | Tablet, Extended releaseOral | Rugby Laboratories | 0536-1161 |
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