Effervescent Orange Cold Relief Tablet, Effervescent
NDC Package 37808-768-20
Package Information
Effervescent Orange Cold Relief (aspirin, chlorpheniramine maleate, phenylephrine bitartrate) tablets is ■ do not use more than directed (see overdose warning)■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours■ do not take more than 8 tablets in 24 hours■ children under 12 years: ask a doctor. This formulation utilizes a tablet, effervescent delivery system. Marketed by H. E. Butt Grocery Company, this product is identified by NDC 37808-768 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1536840 - aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
- RxCUI: 1536840 - ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Decreased Platelet Aggregation - [PE] (Physiologic Effect)
- Decreased Prostaglandin Production - [PE] (Physiologic Effect)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 37808 - H. E. Butt Grocery Company
- 37808-768 - Effervescent Orange Cold Relief
- 37808-768-20 - 10 POUCH in 1 CARTON / 2 TABLET, EFFERVESCENT in 1 POUCH
- 37808-768 - Effervescent Orange Cold 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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 37808-768-20 identifies a specific commercial package of 10 pouch in 1 carton / 2 tablet, effervescent in 1 pouch of Effervescent Orange Cold Relief, a human over the counter drug labeled by H. E. Butt Grocery Company. This tablet, effervescent is formulated for oral use and contains aspirin; chlorpheniramine maleate; phenylephrine bitartrate 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 H. E. Butt Grocery Company on January 30, 2018. The current certification is valid through December 31, 2026.
How is this H. E. Butt Grocery Company product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 37808076820. 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.