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

Spray Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65197-512-04
Package Description:
113 g in 1 CAN
Product Code:
Proprietary Name:
Solarcaine Burn Pain Relief 4oz
Non-Proprietary Name:
Solarcaine Burn Pain Relief 4oz
Substance Name:
Lidocaine Hydrochloride
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
11-Digit NDC Billing Format:
65197051204
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Wellspring Pharmaceutical Corporation
Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Sample Package:
No
FDA Application Number:
M017
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
11-15-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N

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 NDC 65197-512-04?

The NDC Packaged Code 65197-512-04 is assigned to a package of 113 g in 1 can of Solarcaine Burn Pain Relief 4oz, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. The product's dosage form is spray and is administered via topical form.

Is NDC 65197-512 included in the NDC Directory?

Yes, Solarcaine Burn Pain Relief 4oz with product code 65197-512 is active and included in the NDC Directory. The product was first marketed by Wellspring Pharmaceutical Corporation on November 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 65197-512-04?

The 11-digit format is 65197051204. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-265197-512-045-4-265197-0512-04