Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Control (Benzoyl peroxide) NDC 76458-333
Benzoyl peroxide 50 mg/mL · Lotion · Topical · Circadia by Dr Pugliese, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76458-333-02 | 7645803330276458033302 | 1 BOTTLE in 1 CARTON (76458-333-02) / 59 mL in 1 BOTTLEMarketed from Jul 15, 2012 |
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)
- Nighttime Control
- Generic name (nonproprietary)
- benzoyl peroxide
- Active ingredients
- Benzoyl peroxide — 50 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Circadia by Dr Pugliese, Inc.NDC labeler code 76458
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 006
- Marketing start
- Listing expires
- Identifiers
- Product ID 76458-333_0c86a86e-1d0e-8fa8-e063-6294a90a5963SPL ID 0c86a86e-1d0e-8fa8-e063-6294a90a5963SPL set ID fb4cc832-4cfd-4e29-a78e-ab848681a224RxCUI 106309UNII 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
N476458033302followed by a unit qualifier and the quantityPackage 76458-0333-02. 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 76458-333
- What is NDC 76458-333?
- 76458-333 is the product NDC for Nighttime Control (benzoyl peroxide), Benzoyl peroxide 50 mg/mL lotion, listed with the FDA by Circadia by Dr Pugliese, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Control (Benzoyl Peroxide).
- What is the active ingredient?
- Benzoyl peroxide.
- Who is the labeler?
- Circadia by Dr Pugliese, Inc., NDC labeler code 76458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Control?
- 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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