Carolina Crud Crusher Syrup
NDC Package 11383-311-08
Package Information
Carolina Crud Crusher (dextromethorphan hbr, guaifenesin) syrups is take every 4 hoursdo not take more than 6 doses in 24 hoursadults and children 12 years and over2 teaspoonfuls (10 mL)children 6 to under 12 years1 teaspoonful (5 mL)children 2 to under 6 years 1/2 teaspoonful (2-1/2 mL)children under 2 yearsask a doctor. This formulation utilizes a syrup delivery system. Marketed by Weeks & Leo Co., Inc., this product is identified by NDC 11383-311 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
- RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution
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
- 11383 - Weeks & Leo Co., Inc.
- 11383-311 - Carolina Crud Crusher
- 11383-311-08 - 236 mL in 1 BOTTLE
- 11383-311 - Carolina Crud Crusher
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 11383-311-08 identifies a specific commercial package of 236 ml in 1 bottle of Carolina Crud Crusher, a human over the counter drug labeled by Weeks & Leo Co., Inc.. This syrup 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 Weeks & Leo Co., Inc. on June 01, 2022. The current certification is valid through December 31, 2026.
How is this Weeks & Leo Co., Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 11383031108. 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 Product segment to maintain the 5-4-2 structure.