Cold Flu And Sore Throat Relief Liquid
NDC Package 21130-036-06
Package Information
Cold Flu And Sore Throat Relief (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl) liquids is do not take more than directed (see overdose warning)do not take more than 6 doses in a 24-hour period measure only with dosing cup provided.Do not use any other dosing device. keep dosing cup with product dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and older: 20 mL every 4 hours while symptoms last children under 12 years of age: do not use. This formulation utilizes a liquid delivery system. Marketed by Safeway, Inc., this product is identified by NDC 21130-036 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
- RxCUI: 1116572 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
- RxCUI: 1116572 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
- RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution
- RxCUI: 1116572 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- 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)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 21130 - Safeway, Inc.
- 21130-036 - Cold Flu And Sore Throat Relief
- 21130-036-06 - 177 mL in 1 BOTTLE
- 21130-036 - Cold Flu And Sore Throat Relief
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.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 21130-036-06 identifies a specific commercial package of 177 ml in 1 bottle of Cold Flu And Sore Throat Relief Maximum Strength, a human over the counter drug labeled by Safeway, Inc.. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 Safeway, Inc. on June 30, 2014. The current certification is valid through December 31, 2026.
How is this Safeway, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130003606. 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.
