Solarcaine Burn Pain Relief 4oz Spray
NDC Package 65197-512-04

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

Package Information

Solarcaine Burn Pain Relief 4oz sprays is shake welladults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctorto apply to face, spray in palm of hand and gently apply. This formulation utilizes a spray delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-512 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
65197-512-04
Package Description
113 g in 1 CAN
Product Code
65197-512
11-Digit Billing Format
65197051204
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Solarcaine Burn Pain Relief 4oz
Non-Proprietary Name
Solarcaine Burn Pain Relief 4oz
Substance Name
Lidocaine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
LIDOCAINE HYDROCHLORIDE 4 g/100g
Pharmacologic Class
Usage Information
Shake welladults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctorto apply to face, spray in palm of hand and gently apply

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-15-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65197-512-04 identifies a specific commercial package of 113 g in 1 can of Solarcaine Burn Pain Relief 4oz, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This spray is formulated for topical use and contains lidocaine 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 Wellspring Pharmaceutical Corporation on November 15, 2024. The current certification is valid through December 31, 2026.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197051204. 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)
65197-512-04
11-Digit CMS (5-4-2)
65197-0512-04

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