NDC codes

FDA NDC Directory
Product NDC (as listed)11822-3644Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-3644Add 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
11822-3644-311822364403118223644031 BOTTLE, DROPPER in 1 CARTON (11822-3644-3) / 10 mL in 1 BOTTLE, DROPPERMarketed from Aug 3, 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)
Ear Care Earache Drops
Generic name (nonproprietary)
atropa belladonna, anemone pulsatilla, lycopodium clavatum spore, matricaria chamomilla, and sulfur
Active ingredients
Atropa belladonna — 30 [hp_C]/mLOyster shell calcium carbonate, Crude — 30 [hp_C]/mLMatricaria chamomilla — 30 [hp_C]/mLLycopodium clavatum spore — 30 [hp_C]/mLAnemone pulsatilla — 30 [hp_C]/mLSulfur — 30 [hp_C]/mL
Dosage form
Liquid
Route
Auricular (Otic)
Labeler
Rite Aid CorporationNDC labeler code 11822
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 11822-3644_678c8e7e-1d5b-f12a-e053-2991aa0ab6ccSPL ID 678c8e7e-1d5b-f12a-e053-2991aa0ab6ccSPL set ID 58f1f79f-f1dd-3094-e053-2991aa0ac591UNII WQZ3G9PF0H, 2E32821G6I, G0R4UBI2ZZ, C88X29Y479, I76KB35JEV, 70FD1KFU70UPC 0011822364430

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

N411822364403 followed by a unit qualifier and the quantity

Package 11822-3644-03. 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* • For use in the ears only. According to homeopathic indications these ingredients temporarily relieve the symptoms of fever, pain, throbbing, and sleeplessness with earaches after diagnosis by a physician. Relieves common pain and itching of “swimmers ear”. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11822-3644

What is NDC 11822-3644?
11822-3644 is the product NDC for Ear Care Earache Drops, Atropa belladonna 30 [hp_C]/mL + 5 more ingredients liquid, listed with the FDA by Rite Aid Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ear Care Earache Drops (ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, and SULFUR).
What is the active ingredient?
Atropa belladonna, Oyster shell calcium carbonate, Crude, Matricaria chamomilla, Lycopodium clavatum spore, Anemone pulsatilla, Sulfur.
Who is the labeler?
Rite Aid Corporation, NDC labeler code 11822. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ear Care Earache 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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