Over-the-counter drug · ANDA
Berkley and Jensen Mucus Relief DM (Dextromethorphan hbr, guaifenesin) NDC 68391-812
Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 · Tablet, Extended release · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-812-01 | 6839108120168391081201 | 1 BOTTLE in 1 CARTON (68391-812-01) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 4, 2025 | |
| 68391-812-45 | 6839108124568391081245 | 1 BOTTLE in 1 CARTON (68391-812-45) / 56 TABLET, EXTENDED RELEASE in 1 BOTTLEMarketed from Jul 15, 2020 |
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)
- Berkley and Jensen Mucus Relief DM
- Generic name (nonproprietary)
- dextromethorphan hbr, guaifenesin
- Active ingredients
- Guaifenesin — 1200 mg/1Dextromethorphan hydrobromide — 60 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207602
- 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 68391-812_a74d6a6d-c7c6-4e02-a664-9aced70268c4SPL ID a74d6a6d-c7c6-4e02-a664-9aced70268c4
- 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
N468391081201followed by a unit qualifier and the quantityPackage 68391-0812-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68391-812
- What is NDC 68391-812?
- 68391-812 is the product NDC for Berkley and Jensen Mucus Relief DM, Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 tablet, extended release, listed with the FDA by BJWC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Berkley and Jensen Mucus Relief DM (Dextromethorphan HBr, guaifenesin).
- What is the active ingredient?
- Guaifenesin, Dextromethorphan hydrobromide.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Berkley and Jensen Mucus Relief DM?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 207602
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 |
|---|---|---|---|---|
| basic care mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amazon.com Services LLC | 72288-812 |
| DG health mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Dolgencorp, LLC | 55910-575 |
| DG health mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Dolgencorp Inc | 55910-746 |
| equaline mucus dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | United Natural Foods, Inc. dba UNFI | 41163-599 |
| Equaline Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | United Natural Foods, Inc. dba UNFI | 41163-781 |
| equate mucus relief dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | WALMART INC. | 79903-065 |
| Exchange Select Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Army & Air Force Exchange Service | 55301-812 |
| good neighbor pharmacy mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-637 |
| Good Neighbor Pharmacy Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Amerisource Bergen | 46122-817 |
| good sense mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | L Perrigo Company | 0113-0812 |
| Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | L. Perrigo Company | 0113-2219 |
| Good Sense Mucus DMdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7258 |
| Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Sportpharm LLC | 85766-172 |
| kirkland signature mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | Costco Wholesale Company | 63981-812 |
| Leader Mucus Relief DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0722 |
| members mark mucus relief dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Sam's West Inc | 68196-812 |
| mucus dmdextromethorphan hbr, guaifenesin | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | Meijer Distribution Inc | 41250-812 |
| Mucus DMdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 30 mg/1; Guaifenesin 600 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-222 |
| mucus dmdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 60 mg/1; Guaifenesin 1200 mg/1 | Tablet, Extended releaseOral | HyVee Inc | 42507-812 |
| mucus dm extended releaseguaifenesin, dextromethorphan hbr | Guaifenesin 1200 mg/1; Dextromethorphan hydrobromide 60 mg/1 | Tablet, Extended releaseOral | CVS Pharmacy | 69842-812 |
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