NDC codes

FDA NDC Directory
Product NDC (as listed)55319-804Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55319-0804Add 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 NDC11-digit (billing)PackageCopy
55319-804-0155319080401553190804011 BOTTLE in 1 CARTON (55319-804-01) / 12 mL in 1 BOTTLEMarketed from Nov 1, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Family Wellness Ear Relief Ear Drops
Generic name (nonproprietary)
matricaria chamomilla, mercurius solubilis, sulfur
Active ingredients
Matricaria chamomilla — 10 [hp_X]/mLMercurius solubilis — 15 [hp_X]/mLSulfur — 12 [hp_X]/mL
Dosage form
Solution/ drops
Route
Auricular (Otic)
Labeler
Family Dollar Services IncNDC labeler code 55319
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 55319-804_28d9b093-3d3d-4353-e063-6394a90a8d4eSPL ID 28d9b093-3d3d-4353-e063-6394a90a8d4eSPL set ID dba89b5c-fe1d-485d-a1af-d8cd1f15b615UNII G0R4UBI2ZZ, 324Y4038G2, 70FD1KFU70

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

N455319080401 followed by a unit qualifier and the quantity

Package 55319-0804-01. 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 .

Indications (excerpt from the label)

Uses Helps relieve the sensation of fullnes of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55319-804

What is NDC 55319-804?
55319-804 is the product NDC for Family Wellness Ear Relief Ear Drops, Matricaria chamomilla 10 [hp_X]/mL + 2 more ingredients solution/ drops, listed with the FDA by Family Dollar Services Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Family Wellness Ear Relief Ear Drops (Matricaria chamomilla, Mercurius solubilis, Sulfur).
What is the active ingredient?
Matricaria chamomilla, Mercurius solubilis, Sulfur.
Who is the labeler?
Family Dollar Services Inc, NDC labeler code 55319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Family Wellness Ear Relief Ear Drops?
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.

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