Over-the-counter drug · OTC MONOGRAPH DRUG
Dermisa Acne Treatment (Benzoyl peroxide) NDC 68343-123
Benzoyl peroxide 5 g/100g · Cream · Topical · Montani Cosmetics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68343-123-01 | 6834301230168343012301 | 28 g in 1 TUBE (68343-123-01)Marketed from Feb 28, 2013 |
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)
- Dermisa Acne Treatment
- Generic name (nonproprietary)
- benzoyl peroxide
- Active ingredients
- Benzoyl peroxide — 5 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Montani Cosmetics IncNDC labeler code 68343
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 006
- Marketing start
- Listing expires
- Identifiers
- Product ID 68343-123_295765fa-6050-0b18-e063-6394a90a8c49SPL ID 295765fa-6050-0b18-e063-6394a90a8c49SPL set ID d61a6354-8194-da19-e053-2995a90a7e22RxCUI 308693UNII 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
N468343012301followed by a unit qualifier and the quantityPackage 68343-0123-01. 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/Usos For the treatment of acne and to help prevent new acne blemishes / Para el tratamiento de acne y para ayudar a prevenir manchas de acné
Excerpt only. Read the full label for complete information.
About NDC 68343-123
- What is NDC 68343-123?
- 68343-123 is the product NDC for Dermisa Acne Treatment (benzoyl peroxide), Benzoyl peroxide 5 g/100g cream, listed with the FDA by Montani Cosmetics Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dermisa Acne Treatment (Benzoyl Peroxide).
- What is the active ingredient?
- Benzoyl peroxide.
- Who is the labeler?
- Montani Cosmetics Inc, NDC labeler code 68343. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dermisa Acne Treatment?
- 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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