NDC codes

FDA NDC Directory
Product NDC (as listed)36800-846Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0846Add 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
36800-846-07368000846071 BOTTLE in 1 BOX (36800-846-07) / 12 mL in 1 BOTTLEMarketed from Jul 1, 2007

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)
Top Care Ear Relief Ear Drops
Generic name (nonproprietary)
chamomile, mercurius solubilis, sulfur
Active ingredients
Chamomile — 10 [hp_X]/mLMercurius solubilis — 15 [hp_X]/mLSulfur — 12 [hp_X]/mL
Dosage form
Solution/ drops
Route
Auricular (Otic)
Labeler
Topco Associates LLCNDC labeler code 36800
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 36800-846_2f392834-834f-1a02-e063-6394a90a473bSPL ID 2f392834-834f-1a02-e063-6394a90a473bSPL set ID 2e8422f3-546a-4d09-84c0-4aa809ceaa62UNII FGL3685T2X, 324Y4038G2, 70FD1KFU70UPC 0036800171695

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

N436800084607 followed by a unit qualifier and the quantity

Package 36800-0846-07. 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 fullness 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 36800-846

What is NDC 36800-846?
36800-846 is the product NDC for Top Care Ear Relief Ear Drops, Chamomile 10 [hp_X]/mL + 2 more ingredients solution/ drops, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Top Care Ear Relief Ear Drops (Chamomile, Mercurius solubilis, Sulfur).
What is the active ingredient?
Chamomile, Mercurius solubilis, Sulfur.
Who is the labeler?
Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Top Care 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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