What is NDC 54973-3315?

54973-3315 is the product NDC for Baby Oral Pain Relief, Oyster shell calcium carbonate, Crude 12 [hp_X]/g + 5 more ingredients tablet, listed with the FDA by Hyland' Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Baby Oral Pain Relief (Oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla).

What is the active ingredient?

Oyster shell calcium carbonate, Crude, Tribasic calcium phosphate, Arabica coffee bean, Arnica montana, Matricaria chamomilla, Ferrum phosphoricum.

Hyland' Inc., NDC labeler code 54973. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Baby Oral Pain Relief?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Baby Oral Pain Relief NDC 54973-3315

NDC codes

FDA NDC Directory

Product NDC (as listed)54973-3315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54973-3315Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54973-3315-1	5497333150154973331501	1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-1) / 125 g in 1 BOTTLE, PLASTICMarketed from Aug 17, 2017
54973-3315-7	5497333150754973331507	1 BOTTLE, PLASTIC in 1 CARTON (54973-3315-7) / 80 g in 1 BOTTLE, PLASTICMarketed from Aug 17, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Baby Oral Pain Relief
Generic name (nonproprietary): oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla
Active ingredients: Oyster shell calcium carbonate, Crude — 12 [hp_X]/gTribasic calcium phosphate — 12 [hp_X]/gArabica coffee bean — 6 [hp_X]/gArnica montana — 30 [hp_X]/gMatricaria chamomilla — 12 [hp_X]/gFerrum phosphoricum — 12 [hp_X]/g
Dosage form: Tablet
Route: Oral
Labeler: Hyland' Inc.NDC labeler code 54973
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Aug 17, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)
Identifiers: Product ID 54973-3315_2d83ba02-987c-b74b-e063-6294a90a6dc0SPL ID 2d83ba02-987c-b74b-e063-6294a90a6dc0SPL set ID 5904f126-e8f0-a892-e053-2991aa0aef0fUNII 2E32821G6I, 91D9GV0Z28, 3SW678MX72, O80TY208ZW, G0R4UBI2ZZ, 91GQH8I5F7
Pharmacologic class: Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454973331501 followed by a unit qualifier and the quantity

Package 54973-3315-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 6, 2025.

Indications (excerpt from the label)

Uses ■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54973-3315

What is NDC 54973-3315?: 54973-3315 is the product NDC for Baby Oral Pain Relief, Oyster shell calcium carbonate, Crude 12 [hp_X]/g + 5 more ingredients tablet, listed with the FDA by Hyland' Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Baby Oral Pain Relief (Oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla).
What is the active ingredient?: Oyster shell calcium carbonate, Crude, Tribasic calcium phosphate, Arabica coffee bean, Arnica montana, Matricaria chamomilla, Ferrum phosphoricum.
Who is the labeler?: Hyland' Inc., NDC labeler code 54973. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Baby Oral Pain Relief?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.