Over-the-counter drug · OTC MONOGRAPH DRUG
Monat Acne Treatment (Benzoyl peroxide) NDC 78518-295
Benzoyl peroxide 5 g/100mL · Cream · Topical · Monat Global Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78518-295-01 | 78518029501 | 15 mL in 1 TUBE (78518-295-01)Marketed from Mar 21, 2023 |
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)
- Monat Acne Treatment
- Generic name (nonproprietary)
- benzoyl peroxide
- Active ingredients
- Benzoyl peroxide — 5 g/100mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Monat Global CorpNDC labeler code 78518
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 006
- Marketing start
- Listing expires
- Identifiers
- Product ID 78518-295_29b74e5c-3ee4-9bc6-e063-6394a90a50f1SPL ID 29b74e5c-3ee4-9bc6-e063-6394a90a50f1SPL set ID f76eb53e-643d-52cf-e053-6394a90a6e8fRxCUI 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
N478518029501followed by a unit qualifier and the quantityPackage 78518-0295-01. 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)
For the treatment of acne.
Excerpt only. Read the full label for complete information.
About NDC 78518-295
- What is NDC 78518-295?
- 78518-295 is the product NDC for Monat Acne Treatment (benzoyl peroxide), Benzoyl peroxide 5 g/100mL cream, listed with the FDA by Monat Global Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Monat Acne Treatment (Benzoyl Peroxide).
- What is the active ingredient?
- Benzoyl peroxide.
- Who is the labeler?
- Monat Global Corp, NDC labeler code 78518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monat 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 |
|---|---|---|---|---|
| Cetaphil Gentle Clear BPO Acne Cleanserbenzoyl peroxide | Benzoyl peroxide 2.6 g/100mL | CreamTopical | Galderma Laboratories, L.P. | 0299-4125 |
| Anti-Aging Blemish Control Peel Padssalicylic acid | Salicylic acid 2.366 g/118.29g | SwabTopical | June Jacobs Labs, LLC | 65278-318 |
| Acne Treatment Padssalicylic acid | Salicylic acid 1 g/50mL | LotionTopical | Spa de Soleil | 68062-9004 |
| Face Reality 5% Advanced Acne Medbenzoyl peroxide | Benzoyl peroxide 50 mg/mL | CreamTopical | Face Reality | 70707-157 |
| Peace Out Early Stage Acne Dotsalicylic acid | Salicylic acid .14 mg/1 | PatchTopical | Peace Out LLC. | 71494-007 |
| Rugby Benzoyl Peroxide Wash Acne Medicationbenzoyl peroxide | Benzoyl peroxide 100 mg/g | LotionTopical | Rugby Laboratories | 0536-1474 |
| Gentle Acne Serumsalicylic acid | Salicylic acid .5 g/100mL | GelTopical | Drmtlgy, LLC | 83286-016 |
| Acne Treatment Gelsalicylic acid | Salicylic acid 20 mg/mL | GelTopical | S+ | 31720-301 |
| ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Mochasalicylic acid | Salicylic acid 1 mg/mL | EmulsionTopical | ALMAY | 0311-0767 |
| Almay Clear Complexion Makeup Buffsalicylic acid | Salicylic acid 2 mg/2mL | LiquidTopical | Almay | 0311-0742 |
| 10 Acne Medbenzoyl peroxide | Benzoyl peroxide 100 mg/mL | GelTopical | Face Reality, Inc. | 70707-151 |
| Peace Out Acne Day and Night Duosalicylic acid | — | KitTopical | Peace Out LLC. | 71494-003 |
| CosmoClear Cleansersalicylic acid | Salicylic acid 100 mg/mL | SoapTopical | Noon Aesthetics M.R. Ltd | 78863-3025 |
| NAS Tonersalicylic acid | Salicylic acid 1 g/1001 | LiquidTopical | BURT'S BEES, INC. | 26052-042 |
| Daily Medssalicylic acid | Salicylic acid 20 mg/mL | LotionTopical | Bioelements, Inc. | 49825-100 |
| Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansingsalicylic acid | Salicylic acid 5 mg/mL | GelTopical | L'Oreal USA Products Inc | 49967-307 |
| Shiseido Waso Koshirice Acne Calming Treatmentsalicylic acid | Salicylic acid .1 g/20mL | GelTopical | SHISEIDO AMERICAS CORPORATION | 58411-615 |
| Walgreens Maximum Strength Tinted Acne Spot Treatment Creambenzoyl peroxide | Benzoyl peroxide 100 mg/g | CreamTopical | WALGREEN COMPANY | 0363-0256 |
| 2.5 Acne Medbenzoyl peroxide | Benzoyl peroxide 25 mg/mL | GelTopical | Face Reality, Inc. | 70707-152 |
| Peace Out Acne Day and Night Duosalicylic acid | — | KitTopical | Peace Out LLC. | 71494-004 |
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