NDC codes

FDA NDC Directory
Product NDC (as listed)69469-650Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69469-0650Add 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
69469-650-05694690650056946906500514.7 mL in 1 BOTTLE, DROPPER (69469-650-05)Marketed from Oct 28, 2024

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)
Healthy Ears
Generic name (nonproprietary)
carbide peroxide
Active ingredients
Carbamide peroxide — 6.5 mg/mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Vitamex USA, CorpNDC labeler code 69469
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 014
Marketing start
Listing expires
Identifiers
Product ID 69469-650_38429bd1-d2d5-0b3c-e063-6394a90adc71SPL ID 38429bd1-d2d5-0b3c-e063-6394a90adc71SPL set ID 25953441-cd8e-5038-e063-6294a90ae401RxCUI 702050UNII 31PZ2VAU81

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

N469469065005 followed by a unit qualifier and the quantity

Package 69469-0650-05. 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)

Directions Directions Apply 5-10 drops in each affected ear. Supervise children in the use of this product. Do not use for more than 4 days. Adults and children over 12 years of age: the tip of the applicator should not enter the ear canal. Keep the drops in the ear for several minutes by keeping the head tilted or placing cotton in the ear. Any wax remaining after treatment may be removed gently flushing the ear with the warm water, using soft rubber bulb ear syringe. Children 12 years or younger, only use directed by a doctor.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69469-650

What is NDC 69469-650?
69469-650 is the product NDC for Healthy Ears (carbide peroxide), Carbamide peroxide 6.5 mg/mL solution, listed with the FDA by Vitamex USA, Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Healthy Ears (Carbide Peroxide).
What is the active ingredient?
Carbamide peroxide.
Who is the labeler?
Vitamex USA, Corp, NDC labeler code 69469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Healthy Ears?
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
Audiologists Choice Earwax Removal Aid Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Oaktree Products Inc59256-836
TopCare Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Topco Associates LLC76162-836
Equate Swimmers Instant Ear DryIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)Walmart Stores, Inc49035-989
Macks Dry n Clearear drying aidIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)McKeon Products Inc66354-001
Wax Away Earwax Removal Aidcarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)McKeon Products Inc66354-005
Wax Away Earwax Removal Systemcarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)McKeon Products Inc66354-006
ProRinse Earwax Removal Systemcarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)McKeon Products Inc66354-007
HylaTearseye dropsHypromellose 2910 (4000 mpa.s) 3 mg/10mLLiquidOphthalmicHyalogic LLC72094-001
Dri-EarIsopropyl alcohol 950 mg/mLSuspension/ dropsAuricular (Otic)S.S.S. Company12258-153
Ear Wash Refill Equatecarbamide peroxide—KitWalmart79903-403
Debroxcarbamide peroxideCarbamide peroxide 65 mg/mLLiquidAuricular (Otic)A-S Medication Solutions50090-4201
ERO Ear Wax Removal Kitcarbamide peroxide 6.5%Carbamide peroxide 6.5 g/100mLLiquidTopicalRandob Labs52412-175
GoodSense Ear Wax Removal Kitcarbamide peroxideCarbamide peroxide 6.5 g/100mLLiquidTopicalGeiss, Destin & Dunn, Inc50804-117
Foster and Thrive Earwax Removal Kit Ear wax dropscarbamide peroxide—KitMckesson Corp. Via Strategic Sourcing Services70677-1153
HANCHOBIT Lemon Turmeric Kojic Acid BrighteningglycerinLemon .02 g/100g; Turmeric .02 g/100gSoapTopicalHANCHOYEANBIOTEC Co.,Ltd.85164-002
Foster and Thrive Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsTopicalMckesson Corp. Via Strategic Sourcing Services70677-1154
Earwax Removal Dropscarbamide peroxide 6.5%Carbamide peroxide .065 mg/mLLiquidAuricular (Otic)Randob Labs, Ltd.52412-600
Auralytcarbamide peroxideCarbamide peroxide 7.8 mg/12mLLiquidTopicalMenper Distributors, Inc53145-311
Major Earwax Removal Drops Earwax Removal Aidcarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsTopicalMajor Pharmaceuticals0904-7478
JAYSUING Silicone Scar GelglycerinCentella asiatica root .006 mg/30mgGelTopicalShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.85060-007

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