Over-the-counter drug · OTC MONOGRAPH DRUG

Benzoyl Peroxide NDC 35573-453

Benzoyl peroxide 50 mg/mL · Liquid · Topical · Burel Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)35573-453Labeler and product segments. Claims need a package NDC.
Product NDC at billing width35573-0453Add 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
35573-453-083557304530835573045308237 mL in 1 BOTTLE (35573-453-08)Marketed from Apr 15, 2022
35573-453-913557304539135573045391148 mL in 1 BOTTLE (35573-453-91)Marketed from Apr 15, 2022

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)
Benzoyl Peroxide
Generic name (nonproprietary)
benzoyl peroxide
Active ingredients
Benzoyl peroxide — 50 mg/mL
Dosage form
Liquid
Route
Topical
Labeler
Burel Pharmaceuticals, LLCNDC labeler code 35573
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 006
Marketing start
Listing expires
Identifiers
Product ID 35573-453_d51a6f4b-982d-45aa-932f-a9527b294289SPL ID d51a6f4b-982d-45aa-932f-a9527b294289SPL set ID 0617d42d-511d-4c1a-a919-b37abbc14efcRxCUI 142034, 308696UNII W9WZN9A0GMUPC 0335573454081, 0335573454913

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N435573045308 followed by a unit qualifier and the quantity

Package 35573-0453-08. 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)

Use For the treatment of acne

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 35573-453

What is NDC 35573-453?
35573-453 is the product NDC for Benzoyl Peroxide, Benzoyl peroxide 50 mg/mL liquid, listed with the FDA by Burel Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Benzoyl Peroxide.
What is the active ingredient?
Benzoyl peroxide.
Who is the labeler?
Burel Pharmaceuticals, LLC, NDC labeler code 35573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Benzoyl Peroxide?
7 other product NDCs are listed under this name. See all Benzoyl Peroxide NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Benzoyl Peroxide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Benzoyl PeroxideBenzoyl peroxide 100 mg/mLLiquidTopicalBurel Pharmaceuticals, LLC35573-45435573-0454-0835573-0454-91
Benzoyl PeroxideBenzoyl peroxide 25 mg/1000mgGelTopicalMalezia LLC77924-00277924-0002-02
benzoyl peroxideBenzoyl peroxide 10 g/100gSuspensionTopicalBryant Ranch Prepack72162-233772162-2337-02
benzoyl peroxideBenzoyl peroxide 5 g/100gLiquidTopicalBryant Ranch Prepack72162-233872162-2338-02
benzoyl peroxideBenzoyl peroxide 10 g/100gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-30845802-0308-0145802-0308-96
benzoyl peroxideBenzoyl peroxide 2.5 g/100gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-10145802-0101-96
benzoyl peroxideBenzoyl peroxide 5 g/100gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-21645802-0216-0145802-0216-96

Other NDCs under M 006

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

FDA NDC Directory listings under M 006
ProductStrengthForm · routeLabelerProduct NDC
Differin Acne Clearing Body Washsalicylic acidSalicylic acid 20 mg/mLGelTopicalGalderma Laboratories, L.P.0299-4131
Clearing Skin Washsalicylic acidSalicylic acid .501 mg/100mLLiquidTopicalDermalogica, LLC.68479-942
PCA SKIN Intensive Clarity Treatmentsalicylic acidSalicylic acid 2 g/100gGelTopicalCP Skin Health Group, Inc.68726-359
Clear Med 10%benzoyl peroxideBenzoyl peroxide 10 g/100mLLotionTopicalCONTROL CORRECTIVE SKINCARE INC70764-107
Margarite Zinc Creamzinc creamSulfur 1.12 g/28gCreamTopicalRenu Laboratories, LLC76348-413
Acne Washsalicylic acidSalicylic acid 1 mg/100mgLiquidTopicalTarget Corporation82442-805
Proactiv Clean Mineral Acne CleansersulfurSulfur 3 g/100mLCreamTopicalAlchemee, LLC11410-457
Almay Clear Complexion Makeup Warm Beigesalicylic acidSalicylic acid 2 mg/2mLLiquidTopicalAlmay0311-0747
PanOxyl Acne Clearing Spot Treatmentbenzoyl peroxideBenzoyl peroxide 100 mg/gGelTopicalCrown Laboratories0316-0298
Exfo Tonic Acne Treatmentsalicylic acidSalicylic acid 2 g/100mLSolutionTopicalCONTROL CORRECTIVE SKINCARE INC70764-104
Acne Spot Treatmentsalicylic acidSalicylic acid 2 g/100mLGelTopicalCONTROL CORRECTIVE SKINCARE INC70764-105
Tula Skincare Breakout Star Lightweight Acne Moisturizersalicylic acidSalicylic acid 2 g/100mLCreamTopicalThe Procter & Gamble Manufacturing Company84126-229
DermaClear BHA Spot Treatmentsalicylic acidSalicylic acid 2 mg/gGelTopicalAllure Labs62742-4195
Magnilife Eczema Caresulfur, graphite, daphne mezereum bark, toxicodendron pubescens wholeSulfur 1 [hp_X]/g + 3 more ingredientsCreamTopicalThe Magni Group, Inc.43689-0035
Clear Med 5%benzoyl peroxideBenzoyl peroxide 5 g/100mLLotionTopicalCONTROL CORRECTIVE SKINCARE INC70764-106
Up and Up Blemish Controlling Apricot Scrubsalicylic acidSalicylic acid 20 mg/gEmulsionTopicalTARGET CORPORATION11673-930
Neutrogena Stubborn Blackheads Daily Serumsalicylic acidSalicylic acid 5 mg/mLLotionTopicalKenvue Brands LLC69968-0703
DermaClear Serumsalicylic acidSalicylic acid 20 mg/mLCreamTopicalAllure Labs Inc62742-4069
AcNe solutionsalicylic acidSalicylic acid .15 g/30gCreamTopicalNoon Aesthetics M.R. Ltd78863-1220
Kroger Clarify Care Acne Washsalicylic acidSalicylic acid 20 mg/mLLiquidTopicalTHE KROGER COMPANY30142-945

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