NDC codes

FDA NDC Directory
Product NDC (as listed)53943-838Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53943-0838Add 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
53943-838-3453943083834539430838341 BOTTLE in 1 BOX (53943-838-34) / 15 mL in 1 BOTTLEMarketed from Jun 1, 2014

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

Generic name (nonproprietary)
carbamide peroxide
Active ingredients
Carbamide peroxide — 65 mg/mL
Dosage form
Solution/ drops
Route
Auricular (Otic)
Labeler
Discount Drug MartNDC labeler code 53943
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 014
Marketing start
Listing expires
Identifiers
Product ID 53943-838_0c86980d-ee78-96f8-e063-6294a90a42a6SPL ID 0c86980d-ee78-96f8-e063-6294a90a42a6SPL set ID e30c943e-bba5-4520-8f83-16bfa29ee1cfRxCUI 702050UNII 31PZ2VAU81UPC 0093351016646

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

N453943083834 followed by a unit qualifier and the quantity

Package 53943-0838-34. 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 occasional use as an aid to soften, loosen, and remove excessive earwax

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53943-838

What is NDC 53943-838?
53943-838 is the product NDC for Discount Drug Mart Earwax Removal Drops, Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Discount Drug Mart. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Discount Drug Mart Earwax Removal Drops (Carbamide peroxide).
What is the active ingredient?
Carbamide peroxide.
Who is the labeler?
Discount Drug Mart, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Discount Drug Mart Earwax Removal 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.

Other NDCs under M 014

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

FDA NDC Directory listings under M 014
ProductStrengthForm · routeLabelerProduct NDC
Family Care Earwax Removalcarbamide peroxideCarbamide peroxide .065 mg/mLLiquidAuricular (Otic)United Exchange Corp.65923-639
Pain Be GonementholMenthol 9.6 mg/mLCreamTopicalBack to Earth Inc.82721-001
Ear Wax Removal Dropscarbamide peroxide - 6.5%Carbamide peroxide 65 mg/mLSolution/ dropsTopicalGeriCare Pharmaceutical Corp57896-339
DG Health Earwax Removal kitcarbamide peroxide 6.5%Carbamide peroxide 65 mg/mLSolution/ dropsTopicalDOLLAR GENERAL CORPORATION75712-301
Meijer Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Meijer Distribution Inc41250-282
Best Choice Earwax Removal Kitcarbamide peroxideCarbamide peroxide 65 mg/mLLiquidTopicalValu Merchandisers, Co.63941-835
LEADER Ear Drops for SwimmersIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)Cardinal Health, 110 dba Leader70000-0478
Best Choice Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Valu Merchandisers Company63941-836
CaseysDishwashingSoapdishwashing detergent juniper forestChloroxylenol .2 g/100gLiquidCutaneous, TopicalKYNC DESIGN LLC76557-050
CaseysLavendercaseys hand soap lavender scentBenzalkonium chloride .13 g/100gLiquidTopicalKYNC Design LLC76557-051
TheraSealdimethiconeDimethicone 1.7 g/170.1gCreamTopicalBausch Health US, LLC0187-1660
Rite Aid Earwax Removal Dropscarbamide peroxideCarbamide peroxide 6.5 g/100mLLiquidTopicalRite Aid11822-6117
GenRx Anti-Bacterial GelalcoholAlcohol 62 mL/100mLLiquidTopicalPureTek Corporation59088-299
TopCare Swimmers Ear Dropsisopropyl alcoholIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)TOPCO ASSOCIATES36800-064
fungoid tincturemiconazole nitrateMiconazole nitrate 20 mg/mLTinctureTopicalPedinol Pharmacal, Inc.0884-0293
Germa Ubre Mastitismethyl salicylate 2%Methyl salicylate 20 mg/mLOintmentTopicalGerma Products, LLC73635-5807
Germa Manteca Ubre Plus (TIN)methyl salicylate 10%Methyl salicylate 100 mg/mLOintmentTopicalGerma Products, LLC73635-5805
Alcohol Wipeswipe em alcohol wipesAlcohol 75 mL/100mLClothTopicalShaoxing Elite Bio-Tech Co., Ltd.81079-003
Earwax Removal Dropscarbamide peroxide 6.5%Carbamide peroxide .065 mg/mLLiquidAuricular (Otic)Humco Holding Group, Inc0395-9133
Clearcanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)A-S Medication Solutions50090-7426

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