What is NDC 13709-313?

13709-313 is the product NDC for Wax Out Plus (carbamide peroxide drops), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by NEILMED PHARMACEUTICALS INC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Wax Out Plus (Carbamide peroxide drops).

NEILMED PHARMACEUTICALS INC, NDC labeler code 13709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Wax Out Plus?

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.

Wax Out Plus NDC 13709-313 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13709-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13709-0313Add 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
13709-313-01	1370903130113709031301	1 BOTTLE, DROPPER in 1 KIT (13709-313-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from Oct 1, 2019

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): Wax Out Plus
Generic name (nonproprietary): carbamide peroxide drops
Active ingredients: Carbamide peroxide — 65 mg/mL
Dosage form: Solution/ drops
Route: Auricular (Otic)
Labeler: NEILMED PHARMACEUTICALS INCNDC labeler code 13709
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 014
Marketing start: Nov 5, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 13709-313_0eb0da5e-0fa4-b442-e063-6394a90a08f4SPL ID 0eb0da5e-0fa4-b442-e063-6394a90a08f4SPL set ID cf64f4b8-279c-8c1d-e053-2995a90ac853RxCUI 702050UNII 31PZ2VAU81UPC 0705928604162

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

N413709031301 followed by a unit qualifier and the quantity

Package 13709-0313-01. 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 Jan 11, 2024.

Indications (excerpt from the label)

Directions for ReUsable Ear Cleaners For use in the ear only. Make sure to check physical integrity of the tool prior to use. When usingfor teh first time, begin with the COIL tool. Grasp tool comfortably between thumb, index and middle fingers. Direct toward ear. Gently advance tool toward the earcanal and SPIN tool continuously - slowly advancing into the outer portion of canal. Rotate in one direction per insertion. For additional extraction, try the BRISTLE, SCREW or CLUB tools. DO NOT POKE OR JAB INTO EAR. DO NOT FORCIBLY ADVANCE. NOT FOR DEEP CANAL INSERTION. Each person's requirements vary. Impacted earwax should be removed by a health care professional. Check with your physician. DIS…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13709-313

What is NDC 13709-313?: 13709-313 is the product NDC for Wax Out Plus (carbamide peroxide drops), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by NEILMED PHARMACEUTICALS INC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Wax Out Plus (Carbamide peroxide drops).
What is the active ingredient?: Carbamide peroxide.
Who is the labeler?: NEILMED PHARMACEUTICALS INC, NDC labeler code 13709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Wax Out Plus?: 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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Wax Out Plus (Carbamide peroxide drops) NDC 13709-313