Over-the-counter drug · OTC MONOGRAPH DRUG
BenzoAzeline 5 (Benzoyl peroxide) NDC 78863-1300
Benzoyl peroxide 500 mg/mL · Cream · Topical · Noon Aesthetics M.R. Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78863-1300-1 | 7886313000178863130001 | 1 TUBE in 1 CARTON (78863-1300-1) / 50 mL in 1 TUBEMarketed from Mar 1, 2024 | |
| 78863-1300-2 | 7886313000278863130002 | 1 BOTTLE, PUMP in 1 CARTON (78863-1300-2) / 15 mL in 1 BOTTLE, PUMPMarketed from Mar 1, 2024 |
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)
- BenzoAzeline 5
- Generic name (nonproprietary)
- benzoyl peroxide
- Active ingredients
- Benzoyl peroxide — 500 mg/mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Noon Aesthetics M.R. LtdNDC labeler code 78863
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 006
- Marketing start
- Listing expires
- Identifiers
- Product ID 78863-1300_3f3bab85-a2c2-4b2b-97f0-be5007302b9eSPL ID 3f3bab85-a2c2-4b2b-97f0-be5007302b9eSPL set ID 0db88619-a1be-46d0-b1e7-26253a8c50e5UNII W9WZN9A0GM
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
N478863130001followed by a unit qualifier and the quantityPackage 78863-1300-01. 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 the treatment of acne.
Excerpt only. Read the full label for complete information.
About NDC 78863-1300
- What is NDC 78863-1300?
- 78863-1300 is the product NDC for BenzoAzeline 5 (benzoyl peroxide), Benzoyl peroxide 500 mg/mL cream, listed with the FDA by Noon Aesthetics M.R. Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BenzoAzeline 5 (Benzoyl peroxide).
- What is the active ingredient?
- Benzoyl peroxide.
- Who is the labeler?
- Noon Aesthetics M.R. Ltd, NDC labeler code 78863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BenzoAzeline 5?
- 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 006
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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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