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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Benzoyl Peroxide NDC 35573-453 | National Drug Code

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 NDC	11-digit (billing)	Package	Copy
35573-453-08	3557304530835573045308	237 mL in 1 BOTTLE (35573-453-08)Marketed from Apr 15, 2022
35573-453-91	3557304539135573045391	148 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: Apr 15, 2022
Listing expires: Dec 31, 2026
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 Apr 24, 2024.

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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Benzoyl Peroxide	Benzoyl peroxide 100 mg/mL	LiquidTopical	Burel Pharmaceuticals, LLC	35573-454	35573-0454-0835573-0454-91
Benzoyl Peroxide	Benzoyl peroxide 25 mg/1000mg	GelTopical	Malezia LLC	77924-002	77924-0002-02
benzoyl peroxide	Benzoyl peroxide 10 g/100g	SuspensionTopical	Bryant Ranch Prepack	72162-2337	72162-2337-02
benzoyl peroxide	Benzoyl peroxide 5 g/100g	LiquidTopical	Bryant Ranch Prepack	72162-2338	72162-2338-02
benzoyl peroxide	Benzoyl peroxide 10 g/100g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-308	45802-0308-0145802-0308-96
benzoyl peroxide	Benzoyl peroxide 2.5 g/100g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-101	45802-0101-96
benzoyl peroxide	Benzoyl peroxide 5 g/100g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-216	45802-0216-0145802-0216-96

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
Product	Strength	Form · route	Labeler	Product NDC
10 Acne Medbenzoyl peroxide	Benzoyl peroxide 100 mg/mL	GelTopical	Face Reality, Inc.	70707-151
10% Azelaic Acidazelaic acid cream	Azelaic acid 10 g/100g	CreamTopical	Guangzhou Ariel Medical Technology Co., Ltd.	87815-002
111 Medco Benzoyl Peroxidebenzoyl peroxide	Benzoyl peroxide 100 mg/g	SoapTopical	111 Medco	72811-137
111MedCo 2% Salicylic Acid Cleansing Barsalicylic acid	Salicylic acid 20 mg/g	SoapTopical	111MedCo LLC	72811-000
111MedCo 6% Sulfur Skin Cleansing Barsulfur	Sulfur 60 mg/g	SoapTopical	111MedCo LLC	72811-001
14% Azelaic Acidazelaic acid	Azelaic acid 14 g/100g	CreamTopical	Guangzhou Ariel Medical Technology Co., Ltd.	87815-003
14% Azelaic Acid Acneazelaic acid	Azelaic acid 14 g/100g	CreamTopical	Guangdong Bisutang Biotechnology Co., Ltd.	84753-056
2.5 Acne Medbenzoyl peroxide	Benzoyl peroxide 25 mg/mL	GelTopical	Face Reality, Inc.	70707-152
24 Hour Acne Serumbenzoyl peroxide	Benzoyl peroxide 5 g/100g	GelTopical	Drmtlgy, LLC	83286-007
24 Hour Sensitive Skin Acne Clearing Systemsalicylic acid	—	Kit	Acne Free LLC	80861-118
24 Pk Blemish Dotsalicylic acid 0.5%	Salicylic acid .5 g/100g	PatchTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-170
24 Pk Blemish Dotsalicylic acid 0.5%	Salicylic acid .5 g/100g	PatchTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-171
24 Pk Blemish Dotsalicylic acid 0.5%	Salicylic acid .5 g/100g	PatchTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-172
30 day Acne Treatment Kitsalicylic acid, benzoyl peroxide	—	KitTopical	Cosmetic Enterprises Ltd	56152-0250
5 Percent Benzoyl Peroxide Cleanserbenzoyl peroxide	Benzoyl peroxide 50 mg/mL	GelTopical	Brand Evangelists for Beauty Limited	81136-023
Abib Acne foam cleanser Heartleaf foamsalicylic acid	Salicylic acid .65 g/100mL	CreamTopical	Fourcompany Co., Ltd.	73676-101
Acne Advanced Clarifying Hydratorsalicylic acid	Salicylic acid 10 mg/mL	CreamTopical	Eminence Organic Skin Care Ltd.	15751-3030
Acne Advanced Clarifying Masquesalicylic acid	Salicylic acid 5 mg/mL	CreamTopical	Eminence Organic Skin Care Ltd.	15751-3020
Acne Advanced Treatment Systemsalicylic acid	—	Kit	Eminence Organic Skin Care Ltd.	15751-3000
Acne And Line Correcting Serumsalicylic acid	Salicylic acid 10 mg/mL	LotionTopical	CLINIQUE LABORATORIES LLC	49527-053

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