All Nite Solution
NDC Package 0904-6465-09
Package Information
All Nite (acetaminophen, dextromethorphan hbr, doxylamine succinate) solution is •take only as directed – see Overdose warning•use dose cup•do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 6 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use. This formulation utilizes a solution delivery system. Marketed by Major Pharmaceuticals, this product is identified by NDC 0904-6465 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
- RxCUI: 1043400 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
- RxCUI: 1043400 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
- RxCUI: 1043400 - acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
- RxCUI: 1043400 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
Clinical Specifications
- Antihistamine - [EPC] (Established Pharmacologic Class)
- Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
- 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
- 0904 - Major Pharmaceuticals
- 0904-6465 - All Nite
- 0904-6465-09 - 237 mL in 1 BOTTLE
- 0904-6465 - All Nite
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 0904-6465-09 identifies a specific commercial package of 237 ml in 1 bottle of All Nite, a human over the counter drug labeled by Major Pharmaceuticals. This solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 Major Pharmaceuticals on November 19, 2012. The current certification is valid through December 31, 2026.
How is this Major Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904646509. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 total billable units per package. 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 Labeler segment to maintain the 5-4-2 structure.