NDC codes

FDA NDC Directory
Product NDC (as listed)76162-836Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0836Add 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
76162-836-3476162083634761620836341 BOTTLE in 1 BOX (76162-836-34) / 15 mL in 1 BOTTLEMarketed from Jun 1, 2015

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)
TopCare Earwax Removal Drops
Generic name (nonproprietary)
carbamide peroxide
Active ingredients
Carbamide peroxide — 65 mg/mL
Dosage form
Solution/ drops
Route
Auricular (Otic)
Labeler
Topco Associates LLCNDC labeler code 76162
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 014
Marketing start
Listing expires
Identifiers
Product ID 76162-836_0c7ffed4-7f2b-0946-e063-6394a90aef39SPL ID 0c7ffed4-7f2b-0946-e063-6394a90aef39SPL set ID c5b1ad0e-3712-40fd-afbe-54c0b5f1160bRxCUI 702050UNII 31PZ2VAU81UPC 0036800224735

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

N476162083634 followed by a unit qualifier and the quantity

Package 76162-0836-34. 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 76162-836

What is NDC 76162-836?
76162-836 is the product NDC for TopCare Earwax Removal Drops (carbamide peroxide), Carbamide peroxide 65 mg/mL solution/ drops, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TopCare Earwax Removal Drops (Carbamide peroxide).
What is the active ingredient?
Carbamide peroxide.
Who is the labeler?
Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TopCare 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
Alcohol Wipeswipe em alcohol wipesAlcohol 75 mL/100mLClothTopicalShaoxing Elite Bio-Tech Co., Ltd.81079-003
Ear Wax Removal Dropscarbamide peroxide - 6.5%Carbamide peroxide 65 mg/mLSolution/ dropsTopicalSheffield Pharmaceuticals LLC11527-143
Germa Manteca Ubre Plus (TIN)methyl salicylate 10%Methyl salicylate 100 mg/mLOintmentTopicalGerma Products, LLC73635-5805
Germa Ubre Mastitismethyl salicylate 2%Methyl salicylate 20 mg/mLOintmentTopicalGerma Products, LLC73635-5807
Meijer Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)Meijer Distribution Inc41250-282
GenRx Anti-Bacterial GelalcoholAlcohol 62 mL/100mLLiquidTopicalPureTek Corporation59088-299
LEADER Ear Drops for SwimmersIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)Cardinal Health, 110 dba Leader70000-0478
Rite Aid Earwax Removal Dropscarbamide peroxideCarbamide peroxide 6.5 g/100mLLiquidTopicalRite Aid11822-6117
TopCare Swimmers Ear Dropsisopropyl alcoholIsopropyl alcohol 950 mg/mLLiquidAuricular (Otic)TOPCO ASSOCIATES36800-064
Hand Sanitizing with Lavender OilalcoholAlcohol 62 mL/100mLGelTopicalPureTek Corporation59088-413
Family Care Earwax Removalcarbamide peroxideCarbamide peroxide .065 mg/mLLiquidAuricular (Otic)United Exchange Corp.65923-639
CaseysDishwashingSoapdishwashing detergent juniper forestChloroxylenol .2 g/100gLiquidCutaneous, TopicalKYNC DESIGN LLC76557-050
CaseysLavendercaseys hand soap lavender scentBenzalkonium chloride .13 g/100gLiquidTopicalKYNC Design LLC76557-051
Harris Teeter Earwax Removal Dropscarbamide peroxide 6.5%Carbamide peroxide 6.5 g/100mLLiquidTopicalHarris Teeter LLC69256-117
Clearcanal Ear Wax Softerner Dropscarbamide peroxideCarbamide peroxide 65 mg/mLSolution/ dropsAuricular (Otic)A-S Medication Solutions50090-7426
Good Neighbor Pharmacy Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLLiquidTopicalProficient Rx LP71205-260
DISCOUNT drug mart FOOD FAIR earwax removal kitcarbamide peroxideCarbamide peroxide 65 mg/mLSolutionTopicalDiscount Drug Mart53943-835
Quality Choice Earwax Removal Dropscarbamide peroxideCarbamide peroxide 65 mg/mLLiquidTopicalChain Drug Marketing Association, Inc.63868-027
blue goo FREEZING PAIN RELIEF Topical Analgesicmenthol 4%Menthol 40 mg/mLLiquidTopicalGarcoa, Inc.67385-286
Quality Choice Earwax Removal Kitcarbamide peroxideCarbamide peroxide 65 mg/mLLiquidTopicalChain Drug Marketing Association, Inc.63868-026

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