NDC codes

FDA NDC Directory
Product NDC (as listed)55346-3501Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55346-3501Add 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
55346-3501-155346350101553463501011863 mL in 1 BOTTLE, PLASTIC (55346-3501-1)Marketed from Jun 12, 2020
55346-3501-25534635010255346350102473 mL in 1 BOTTLE (55346-3501-2)Marketed from Nov 24, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Peroxy Shield Mouth Sore
Generic name (nonproprietary)
1.5% hydrogen peroxide
Active ingredients
Hydrogen peroxide — 1.5 mL/100mL
Dosage form
Rinse
Route
Oral
Labeler
Dental Technologies, Inc.NDC labeler code 55346
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 022
Marketing start
Listing expires
Identifiers
Product ID 55346-3501_42c86f95-5c63-ba41-e063-6294a90af8c6SPL ID 42c86f95-5c63-ba41-e063-6294a90af8c6SPL set ID a72e433b-1b7d-4a0c-e053-2995a90a30c4RxCUI 199011, 2480895UNII BBX060AN9V

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455346350101 followed by a unit qualifier and the quantity

Package 55346-3501-01. 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 .

Indications (excerpt from the label)

Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55346-3501

What is NDC 55346-3501?
55346-3501 is the product NDC for Peroxy Shield Mouth Sore (1.5% hydrogen peroxide), Hydrogen peroxide 1.5 mL/100mL rinse, listed with the FDA by Dental Technologies, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Peroxy Shield Mouth Sore (1.5% Hydrogen Peroxide).
What is the active ingredient?
Hydrogen peroxide.
Who is the labeler?
Dental Technologies, Inc., NDC labeler code 55346. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Peroxy Shield Mouth Sore?
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 022

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 022
ProductStrengthForm · routeLabelerProduct NDC
HurriCaine Topical AnestheticbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-1820
Organic Peppermint Herb Throat DropsmentholMenthol 1.9 mg/1LozengeOralRicola USA Inc.63667-010
Equate Sculpted White TP Equate Sculpted White TPsodium fluorideSodium fluoride .15 g/100gPaste, DentifriceOralWalmart79903-282
Ki No Sincalcium carbonateCalcium carbonate 55 mg/500mgTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-322
R B onephosphatidylserine, zinc oxideZinc oxide 6.38 mg/1100mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-140
Sensodynepotassium nitrate and sodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0550
parodontaxstannous fluorideStannous fluoride 1.1 mg/gPasteDentalHaleon US Holdings LLC0135-0598
CVS Health Sensitive Enamel Repairsodium fluorideSodium fluoride .15 g/100g; Potassium nitrate 5 g/100gPaste, DentifriceOralCVS51316-169
Alzh Lphosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-230
TopicalebenzocaineBenzocaine 180 mg/gOintmentOralMedical Products Laboratories, Inc.10733-162
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gPaste, DentifriceTopicalWalgreens0363-5337
Walgreens Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralWalgreens0363-5820
Dem Zerophosphatidylserine, magnesium oxidePhosphatidyl serine 214.43 mg/450mg + 2 more ingredientsTabletOralNPG Bio Pharmaceuticals Co.,Ltd.84540-240
Benzoin Tincturebenzoin resinBenzoin resin 1000 mg/mLLiquidTopical11695664470677-1200
Rite Aid Maximum StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-0345
Chloraseptic Sore Throat CitrusphenolPhenol 1.4 g/100mLSprayOralPrestige Brands Holdings, Inc.67172-112
Sore Throat Relief Cherry FlavorphenolPhenol 1.4 g/100mLSprayOralCardinal Health70000-0458
HurriCaine Topical Anesthetic GelbenzocaineBenzocaine 200 mg/gGelDental, Oral, PeriodontalBeutlich Pharmaceuticals, LLC0283-0293
Rite Aid Professional StrengthbenzocaineBenzocaine 20 g/100gLiquidOralRite Aid11822-5340
Benzocaine 20%Benzocaine 200 mg/mLSolutionTopicalPAI Holdings, LLC dba PAI Pharma0121-1077

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