Baby Oral Pain Relief Tablet
NDC Package 54973-3315-7

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

Baby Oral Pain Relief (oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla) tablets is children under 6 months of age: dissolve 1 tablet on tongue every 15 minutes for 4 doses, then hourly until relieved. This formulation utilizes a tablet delivery system. Marketed by Hyland' Inc., this product is identified by NDC 54973-3315.

Identification & Billing

NDC Package Code
54973-3315-7
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 80 g in 1 BOTTLE, PLASTIC
Product Code
54973-3315
11-Digit Billing Format
54973331507

Clinical Specifications

Proprietary Name
Baby Oral Pain Relief
Non-Proprietary Name
Oyster Shell Calcium Carbonate, Crude, Tribasic Calcium Phosphate, Arabica Coffee Bean, Arnica Montana, Ferrum Phosphoricum And Matricaria Chamomilla
Substance Name
Arabica Coffee Bean; Arnica Montana; Ferrum Phosphoricum; Matricaria Chamomilla; Oyster Shell Calcium Carbonate, Crude; Tribasic Calcium Phosphate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Children under 6 months of age: dissolve 1 tablet on tongue every 15 minutes for 4 doses, then hourly until relieved. Children 6 months to 3 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved. Hyland’s Baby Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

Regulatory & Marketing

Labeler Name
Hyland' Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
08-17-2017
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 (54973-3315). Click a package code to view its specific billing and regulatory data.

54973-3315-1
1 BOTTLE, PLASTIC in 1 CARTON / 125 g in 1 BOTTLE, PLASTIC
54973-3315-3
6 g in 1 PACKET

* 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 54973-3315-7 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 80 g in 1 bottle, plastic of Baby Oral Pain Relief, a human over the counter drug labeled by Hyland' Inc.. This tablet is formulated for oral use and contains arabica coffee bean; arnica montana; ferrum phosphoricum; matricaria chamomilla; oyster shell calcium carbonate, crude; tribasic calcium phosphate 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 Hyland' Inc. on August 17, 2017. The current certification is valid through December 31, 2026.

How is this Hyland' Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54973331507. 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 (5-4-1)
54973-3315-7
11-Digit CMS (5-4-2)
54973-3315-07

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