Hylands Naturals Earache Drops NDC 54973-4124

NDC codes

FDA NDC Directory

Product NDC (as listed)54973-4124Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54973-4124Add 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
54973-4124-1	54973412401	1 BOTTLE, DROPPER in 1 CARTON (54973-4124-1) / 10 mL in 1 BOTTLE, DROPPERMarketed from Jul 27, 2023

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): Hylands Naturals Earache Drops
Generic name (nonproprietary): belladonna leaf,calcium carbonate,chamomile,lycopodium clavatum spore,anemone patens whole,sulfur
Active ingredients: Chamomile — 30 [hp_C]/mLLycopodium clavatum spore — 30 [hp_C]/mLPulsatilla patens whole — 30 [hp_C]/mLSulfur — 30 [hp_C]/mLCalcium carbonate — 30 [hp_C]/mLBelladonna leaf — 30 [hp_C]/mL
Dosage form: Liquid
Route: Auricular (Otic)
Labeler: Hyland's Inc.
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Jul 27, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 54973-4124_59d42624-de71-d5fa-e063-6394a90a7363SPL ID 59d42624-de71-d5fa-e063-6394a90a7363SPL set ID 017ed754-9fe8-2cb5-e063-6294a90ab2f6UNII FGL3685T2X, C88X29Y479, 4M1169RWJD, 70FD1KFU70, H0G9379FGK, 6GZW20TIOI
Pharmacologic class: Blood Coagulation Factor; Phosphate Binder

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N454973412401 followed by a unit qualifier and the quantity

Package 54973-4124-01. 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 Aug 24, 2026.

Indications (excerpt from the label)

Uses* Temporarily relieves: ■ common pain or itching from swimmer’s ear ■ clogged ears ■ ear pain or itching from other earaches, after diagnosis by a physician

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)