Lansinoh Baby
NDC Package 53997-100-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lansinoh Baby is cHANGE WET AND SOILED DIAPERS PROMPTLY  CLEANSE THE DIAPER AREA   ALLOW TO DRY   APPLY OINTMENT LIBERALLY AS OFTEN AS NECESSARY, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANY TIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGEDCAMBIE SIN  DEMORS LOS PANALES MOJADOS O SUCIOS   LIMPIE LA ZONA DEL PANAL  DEJE SECAR  APLIQUE ESTE UNGENTO ABUNDANTEMENTE Y TAN A MENUDO COMO SEA NECESARIO CUANDO CAMBIE EL PANAL, ESPECIALMENTE A LA HORA DE IR A DORMIR O EN CUALQUIER SITUACION EN QUE EL CONTACTO CON EL PANAL MOJADO PUDIERA SER PROLONGADO. Marketed by Lansinoh Laboratories, Inc., this product is identified by NDC 53997-100 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
53997-100-01
Package Description
85 g in 1 TUBE
Product Code
53997-100
11-Digit Billing Format
53997010001
RxNorm Crosswalk
  • RxCUI: 1150463 - dimethicone 5 % / lanolin 15.5 % / zinc oxide 5.5 % Topical Ointment
  • RxCUI: 1150463 - dimethicone 0.05 MG/MG / lanolin 0.155 MG/MG / zinc oxide 0.055 MG/MG Topical Ointment
  • RxCUI: 1150463 - dimethicone 0.05 MG/MG / Lanolin 0.155 MG/MG / ZNO 0.055 MG/MG Topical Ointment
  • RxCUI: 1441318 - Lansinoh baby 5 % / 15.5 % / 5.5 % Topical Ointment
  • RxCUI: 1441318 - dimethicone 0.05 MG/MG / lanolin 0.155 MG/MG / zinc oxide 0.055 MG/MG Topical Ointment [Lansinoh Baby]

Clinical Specifications

Proprietary Name
Lansinoh Baby
Dosage Form
-
Usage Information
CHANGE WET AND SOILED DIAPERS PROMPTLY  CLEANSE THE DIAPER AREA   ALLOW TO DRY   APPLY OINTMENT LIBERALLY AS OFTEN AS NECESSARY, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANY TIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGEDCAMBIE SIN  DEMORS LOS PANALES MOJADOS O SUCIOS   LIMPIE LA ZONA DEL PANAL  DEJE SECAR  APLIQUE ESTE UNGENTO ABUNDANTEMENTE Y TAN A MENUDO COMO SEA NECESARIO CUANDO CAMBIE EL PANAL, ESPECIALMENTE A LA HORA DE IR A DORMIR O EN CUALQUIER SITUACION EN QUE EL CONTACTO CON EL PANAL MOJADO PUDIERA SER PROLONGADO

Regulatory & Marketing

Labeler Name
Lansinoh Laboratories, Inc.
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53997-100-01 identifies a specific commercial package of 85 g in 1 tube of Lansinoh Baby, labeled by Lansinoh Laboratories, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Lansinoh Laboratories, Inc. on January 01, 2011. The current certification is valid through December 31, 2017.

How is this Lansinoh Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53997010001. 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)
53997-100-01
11-Digit CMS (5-4-2)
53997-0100-01

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