NDC codes

FDA NDC Directory
Product NDC (as listed)21922-023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0023Add 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
21922-023-1721922002317219220023171 BOTTLE, PUMP in 1 PACKAGE (21922-023-17) / 2 g in 1 BOTTLE, PUMPMarketed from Oct 10, 2022
21922-023-1821922002318219220023181 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBEMarketed from Oct 10, 2022

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)
Docosanol
Generic name (nonproprietary)
docosanol
Active ingredients
Docosanol — 100 mg/g
Dosage form
Cream
Route
Topical
Labeler
Encube Ethicals, Inc.NDC labeler code 21922
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212385
Marketing start
Listing expires
Identifiers
Product ID 21922-023_a1fe87d9-27cf-4ff0-9e70-52b038882e36SPL ID a1fe87d9-27cf-4ff0-9e70-52b038882e36SPL set ID 5b3137d3-c186-4c5d-89d2-ec5d1c3da8cdRxCUI 797534UNII 9G1OE216XY

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N421922002317 followed by a unit qualifier and the quantity

Package 21922-0023-17. 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)

USE(S) treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21922-023

What is NDC 21922-023?
21922-023 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Docosanol.
What is the active ingredient?
Docosanol.
Who is the labeler?
Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Docosanol?
35 other product NDCs are listed under this name. See all Docosanol 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 Docosanol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DocosanolDocosanol 100 mg/gCreamTopicalBIONPHARMA INC.69452-55069452-0550-0269452-0550-61
DocosanolDocosanol 100 mg/gCreamTopicalDr.Reddys' Laboratories Inc43598-94643598-0946-0243598-0946-1343598-0946-22
DocosanolDocosanol 100 mg/gCreamTopicalDr.Reddys' Laboratories Inc43598-04443598-0044-0243598-0044-33
DocosanolDocosanol 100 mg/gCreamTopicalKLM Laboratories Private Limited84725-00184725-0001-0184725-0001-0284725-0001-09
DocosanolDocosanol 100 mg/gCreamTopicalLeader/ Cardinal Health 110, Inc.70000-074370000-0743-01
DocosanolDocosanol 100 mg/gCreamTopicalWALMART INC. (see also Equate)79903-40279903-0402-1079903-0402-20
DocosanolDocosanol 100 mg/gCreamTopicalPublix Super Markets Inc.41415-66041415-0660-03
DocosanolDocosanol 100 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-68246708-0682-0146708-0682-03
DocosanolDocosanol 100 mg/gCreamTopicalH2-Pharma, LLC61269-88161269-0881-35
DocosanolDocosanol 100 mg/gCreamTopicalYYBA Corp73581-00473581-0004-0273581-0004-0373581-0004-10+1 more

All 36 Docosanol NDCs

Other NDCs under ANDA 212385

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212385
ProductStrengthForm · routeLabelerProduct NDC
Cold Sore TreatmentdocosanolDocosanol 100 mg/gCreamTopicalP & L Development, LLC59726-112
Cold Sore Fever BlisterdocosanolDocosanol 100 mg/gCreamTopicalP & L Development, LLC59726-221
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalMeijer Distribution Inc.79481-0065
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalSafeway, Inc.21130-605
DocosanolDocosanol 100 mg/gCreamTopicalH2-Pharma, LLC61269-881
DocosanolDocosanol 100 mg/gCreamTopicalH2-Pharma, LLC61269-989
Cold Sore TreatmentdocosanolDocosanol 100 mg/gCreamTopicalP & L Development, LLC59726-922
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalWalgreens0363-6510
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalThe Kroger Co.30142-869
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-859
DocosanolDocosanol 100 mg/gCreamTopicalAAFES/Your Military Exchanges55301-112
DocosanolDocosanol 100 mg/gCreamTopicalCare One (Retail Business Services, LLC.)72476-965
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalTARGET Corporation11673-769
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalStrategic Sourcing Services LLC70677-1255
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalWALMART INC. (see also Equate)79903-248
DocosanolDocosanol 100 mg/gCreamTopicalSafeway, Inc.21130-770
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalSportpharm LLC85766-239
Cold Sore Fever BlisterdocosanolDocosanol 100 mg/gCreamTopicalH E B37808-661
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-550
Cold Sore Fever Blister TreatmentdocosanolDocosanol 100 mg/gCreamTopicalH E B37808-765

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