Safetussin Pm Nighttime Liquid
NDC Package 55505-221-33

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Safetussin Pm Nighttime (dextromethorphan hbr, doxylamine succinate) liquids is ▪do not take more than 4 doses in any 24-hour period age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years ask a doctor children under 4 years do not use. This formulation utilizes a liquid delivery system. Marketed by Kramer Laboratories, this product is identified by NDC 55505-221 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
55505-221-33
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
55505-221
11-Digit Billing Format
55505022133
RxNorm Crosswalk
  • RxCUI: 1115329 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution
  • RxCUI: 1115329 - dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Safetussin Pm Nighttime Cough Relief
Non-Proprietary Name
Dextromethorphan Hbr, Doxylamine Succinate
Substance Name
Dextromethorphan; Doxylamine Succinate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
▪do not take more than 4 doses in any 24-hour period age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years ask a doctor children under 4 years do not use

Regulatory & Marketing

Labeler Name
Kramer Laboratories
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-28-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55505-221). Click a package code to view its specific billing and regulatory data.

55505-221-36
1 BOTTLE, PLASTIC in 1 CARTON / 237 mL in 1 BOTTLE, PLASTIC

* 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 55505-221-33 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Safetussin Pm Nighttime Cough Relief, a human over the counter drug labeled by Kramer Laboratories. This liquid is formulated for oral use and contains dextromethorphan; 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 Kramer Laboratories on July 28, 2023. The current certification is valid through December 31, 2026.

How is this Kramer Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55505022133. 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:

10-Digit Format (5-3-2)
55505-221-33
11-Digit CMS (5-4-2)
55505-0221-33

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.