What is NDC 15579-838?

15579-838 is the product NDC for Otix Ear wax Removal Drops (carbamide peroxide), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Bell Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Otix Ear wax Removal Drops (Carbamide peroxide).

Bell Pharmaceuticals, Inc., NDC labeler code 15579. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Otix Ear wax 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.

Otix Ear wax Removal Drops NDC 15579-838

NDC codes

FDA NDC Directory

Product NDC (as listed)15579-838Labeler and product segments. Claims need a package NDC.

Product NDC at billing width15579-0838Add 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 NDC	11-digit (billing)	Package	Copy
15579-838-34	1557908383415579083834	1 BOTTLE in 1 BOX (15579-838-34) / 15 mL in 1 BOTTLEMarketed from Oct 1, 2021

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): Otix Ear wax Removal Drops
Generic name (nonproprietary): carbamide peroxide
Active ingredients: Carbamide peroxide — 65 mg/mL
Dosage form: Solution/ drops
Route: Auricular (Otic)
Labeler: Bell Pharmaceuticals, Inc.NDC labeler code 15579
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 014
Marketing start: Oct 1, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 15579-838_0c7fd25e-6acd-1a54-e063-6294a90af27dSPL ID 0c7fd25e-6acd-1a54-e063-6294a90af27dSPL set ID 0e70ab09-9360-4ab6-a1fe-6f82af392581RxCUI 702050, 2588948UNII 31PZ2VAU81UPC 0023074805883

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

N415579083834 followed by a unit qualifier and the quantity

Package 15579-0838-34. 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 Dec 14, 2023.

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 15579-838

What is NDC 15579-838?: 15579-838 is the product NDC for Otix Ear wax Removal Drops (carbamide peroxide), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Bell Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Otix Ear wax Removal Drops (Carbamide peroxide).
What is the active ingredient?: Carbamide peroxide.
Who is the labeler?: Bell Pharmaceuticals, Inc., NDC labeler code 15579. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Otix Ear wax 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
Product	Strength	Form · route	Labeler	Product NDC
Alcohol Wipeswipe em alcohol wipes	Alcohol 75 mL/100mL	ClothTopical	Shaoxing Elite Bio-Tech Co., Ltd.	81079-003
Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Oaktree Products Inc	59256-836
Audiologists Choice Earwax Removal Systemcarbamide peroxide	Carbamide peroxide 65 mg/mL	LiquidTopical	Oaktree Products Inc.	59256-001
Auralytcarbamide peroxide	Carbamide peroxide 7.8 mg/12mL	LiquidTopical	Menper Distributors, Inc	53145-311
Auro Driisopropyl alcohol	Isopropyl alcohol 95 mL/100mL	LiquidAuricular (Otic)	Insight Pharmaceuticals LLC	63736-327
Bacitracin	Bacitracin 500 [USP'U]/g	OintmentTopical	NuCare Pharmaceuticals,Inc.	68071-5253
Benzoyl Peroxide Acne Medicationbenzoyl peroxide	Benzoyl peroxide 50 mg/mL	GelTopical	NuCare Pharmaceuticals,Inc.	68071-2307
Best Choice Earwax Removal Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Valu Merchandisers Company	63941-836
Best Choice Earwax Removal Kitcarbamide peroxide	Carbamide peroxide 65 mg/mL	LiquidTopical	Valu Merchandisers, Co.	63941-835
blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4%	Menthol 40 mg/mL	LiquidTopical	Garcoa, Inc.	67385-286
blue goo NERVE EASE Pain RELIEF Topical Analgesiclidocaine hcl 4%, menthol 1%	Lidocaine 40 mg/mL; Menthol 10 mg/mL	LiquidTopical	Garcoa, Inc.	67385-825
Bodyographypro Anti-Bacterial Sanitizingethyl alcohol	Alcohol 60 mL/100mL	SprayTopical	Robanda International, Inc.	53950-6010
Caladrylferric oxide red, zinc oxide, and pramoxine hydrochloride	Ferric oxide red 1.36 mg/mL + 2 more ingredients	LotionTopical	Bausch Health US, LLC	0187-5465
Caladryl Clearpramoxine hydrochloride and zinc acetate	Pramoxine hydrochloride 10 mg/mL; Zinc acetate 1 mg/mL	LotionTopical	Bausch Health US, LLC	0187-5466
Carbamide peroxide 6.5%earwax removal kit	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Allegiant Health	69168-488
CareOne Earwax Removal Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Retail Business Services, LLC	72476-838
CaseysDishwashingSoapdishwashing detergent juniper forest	Chloroxylenol .2 g/100g	LiquidCutaneous, Topical	KYNC DESIGN LLC	76557-050
CaseysLavendercaseys hand soap lavender scent	Benzalkonium chloride .13 g/100g	LiquidTopical	KYNC Design LLC	76557-051
ClearCanal Ear Wax Softerner Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	NeilMed Pharmaceuticals, Inc.	13709-230
Clearcanal Ear Wax Softerner Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	A-S Medication Solutions	50090-7426

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Otix Ear wax Removal Drops (Carbamide peroxide) NDC 15579-838