NDC codes

FDA NDC Directory
Product NDC (as listed)0168-0126Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00168-0126Add 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
0168-0126-9100168012691001680126911 BOTTLE, DROPPER in 1 CARTON (0168-0126-91) / 29.57 mL in 1 BOTTLE, DROPPERMarketed from Apr 3, 1970

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Swim-EAR
Generic name (nonproprietary)
swim-ear
Active ingredients
Isopropyl alcohol — 950 mg/mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Fougera Pharmaceuticals, LLCNDC labeler code 0168
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication 344
Marketing start
Listing expires
Identifiers
Product ID 0168-0126_f41c4af6-33dd-48b1-bff2-a4eefad5e70aSPL ID f41c4af6-33dd-48b1-bff2-a4eefad5e70aSPL set ID b849acb5-e20b-464c-948b-8dcc51fdaf70RxCUI 631799UNII ND2M416302UPC 0301680126913

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

N400168012691 followed by a unit qualifier and the quantity

Package 00168-0126-91. 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 Dries water in the ears and relieves water-clogged ears after: • swimming • showering • bathing • washing the hair.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0126

What is NDC 0168-0126?
0168-0126 is the product NDC for Swim-EAR, Isopropyl alcohol 950 mg/mL solution, listed with the FDA by Fougera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Swim-EAR.
What is the active ingredient?
Isopropyl alcohol.
Who is the labeler?
Fougera Pharmaceuticals, LLC, NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Swim-EAR?
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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