Mucus Relief Dm Extended Release Caplets Tablet, Extended Release
NDC Package 17856-1162-1
Package Information
Mucus Relief Dm Extended Release Caplets (guaifenesin, dextromethorphan hbr) tablets is do not crush, chew, or break tablettake with a full glass of water this product can be administered without regards for timing of mealsadults and children 12 years of age and older: 1 or 2 tablet every 12 hours; not more than 4 tablets in 24 hourschildren under 12 years of age: do not use. This formulation utilizes a tablet, extended release delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-1162 and is authorized under FDA application ANDA209692.
Identification & Billing
- RxCUI: 1298324 - guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet
- RxCUI: 1298324 - 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet
- RxCUI: 1298324 - dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet
Clinical Specifications
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
Regulatory & Marketing
Hierarchy Structure
- 17856 - Atlantic Biologicals Corp.
- 17856-1162 - Mucus Relief Dm Extended Release Caplets
- 17856-1162-1 - 100 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- 17856-1162 - Mucus Relief Dm Extended Release Caplets
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 17856-1162-1 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Mucus Relief Dm Extended Release Caplets, a human over the counter drug labeled by Atlantic Biologicals Corp.. This tablet, extended release is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Atlantic Biologicals Corp. on December 13, 2018. The current certification is valid through December 31, 2026.
How is this Atlantic Biologicals Corp. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856116201. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.