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
Audiologists Choice Earwax Removal Aid Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Oaktree Products Inc	59256-836
TopCare Earwax Removal Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	Topco Associates LLC	76162-836
Equate Swimmers Instant Ear Dry	Isopropyl alcohol 950 mg/mL	LiquidAuricular (Otic)	Walmart Stores, Inc	49035-989
Macks Dry n Clearear drying aid	Isopropyl alcohol 950 mg/mL	LiquidAuricular (Otic)	McKeon Products Inc	66354-001
Wax Away Earwax Removal Aidcarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	McKeon Products Inc	66354-005
Wax Away Earwax Removal Systemcarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	McKeon Products Inc	66354-006
ProRinse Earwax Removal Systemcarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsAuricular (Otic)	McKeon Products Inc	66354-007
HylaTearseye drops	Hypromellose 2910 (4000 mpa.s) 3 mg/10mL	LiquidOphthalmic	Hyalogic LLC	72094-001
Dri-Ear	Isopropyl alcohol 950 mg/mL	Suspension/ dropsAuricular (Otic)	S.S.S. Company	12258-153
Ear Wash Refill Equatecarbamide peroxide	—	Kit	Walmart	79903-403
Debroxcarbamide peroxide	Carbamide peroxide 65 mg/mL	LiquidAuricular (Otic)	A-S Medication Solutions	50090-4201
ERO Ear Wax Removal Kitcarbamide peroxide 6.5%	Carbamide peroxide 6.5 g/100mL	LiquidTopical	Randob Labs	52412-175
GoodSense Ear Wax Removal Kitcarbamide peroxide	Carbamide peroxide 6.5 g/100mL	LiquidTopical	Geiss, Destin & Dunn, Inc	50804-117
Foster and Thrive Earwax Removal Kit Ear wax dropscarbamide peroxide	—	Kit	Mckesson Corp. Via Strategic Sourcing Services	70677-1153
HANCHOBIT Lemon Turmeric Kojic Acid Brighteningglycerin	Lemon .02 g/100g; Turmeric .02 g/100g	SoapTopical	HANCHOYEANBIOTEC Co.,Ltd.	85164-002
Foster and Thrive Earwax Removal Dropscarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsTopical	Mckesson Corp. Via Strategic Sourcing Services	70677-1154
Earwax Removal Dropscarbamide peroxide 6.5%	Carbamide peroxide .065 mg/mL	LiquidAuricular (Otic)	Randob Labs, Ltd.	52412-600
Auralytcarbamide peroxide	Carbamide peroxide 7.8 mg/12mL	LiquidTopical	Menper Distributors, Inc	53145-311
Major Earwax Removal Drops Earwax Removal Aidcarbamide peroxide	Carbamide peroxide 65 mg/mL	Solution/ dropsTopical	Major Pharmaceuticals	0904-7478
JAYSUING Silicone Scar Gelglycerin	Centella asiatica root .006 mg/30mg	GelTopical	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	85060-007

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Wax Out Plus (Carbamide peroxide drops) NDC 13709-313