NDC codes

FDA NDC Directory
Product NDC (as listed)53799-277Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53799-0277Add 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
53799-277-11537990277115379902771110 mL in 1 BOTTLE, GLASS (53799-277-11)Marketed from Jul 2, 2013

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)
Earache Relief
Generic name (nonproprietary)
chamomilla and mercurius solubilis and sulphur
Active ingredients
Chamomile — 10 [hp_X]/10mLMercurius solubilis — 15 [hp_X]/10mLSulfur — 12 [hp_X]/10mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Similasan AGNDC labeler code 53799
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 53799-277_7b40fe63-4595-4977-8a66-853b0598e58dSPL ID 7b40fe63-4595-4977-8a66-853b0598e58dSPL set ID b9749db9-a2e4-4460-8769-6150285a7413UNII FGL3685T2X, 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

N453799027711 followed by a unit qualifier and the quantity

Package 53799-0277-11. 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 * According to homeopathic principles, the active ingredients in this product temporarily relieve earache symptoms such as: • sensation of fullness of the ear • sensitivity to cold, drafts, and water • 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 53799-277

What is NDC 53799-277?
53799-277 is the product NDC for Earache Relief, Chamomile 10 [hp_X]/10mL + 2 more ingredients solution, listed with the FDA by Similasan AG. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Earache Relief (Chamomilla and Mercurius Solubilis and Sulphur).
What is the active ingredient?
Chamomile, Mercurius solubilis, Sulfur.
Who is the labeler?
Similasan AG, NDC labeler code 53799. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Earache Relief?
2 other product NDCs are listed under this name. See all Earache Relief NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Earache Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Earache Reliefbelladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris)Atropa belladonna 12 [hp_X]/1 + 7 more ingredientsTabletOralThe Magni Company43689-002043689-0020-02
EarAche Reliefapis mellifera, arnica montana, atropa belladonna, tribasic calcium phosphate, echinacea, unspecified, calcium sulfide, mercurius solubilisApis mellifera 6 [hp_X]/1 + 6 more ingredientsTablet, Orally disintegratingOralTRP Company17312-02517312-0025-14

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