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Nighttime Control Benzoyl Peroxide 50 mg/mL Lotion — NDC 76458-333-02 (Billing 76458-0333-02)

by Circadia by Dr Pugliese, Inc. · 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE

This is a package of Nighttime Control Benzoyl Peroxide 50 mg/mL Lotion from Circadia by Dr Pugliese, Inc., marketed since Jul 2012 and currently FDA-listed. It is this product's only package size.

NDC 76458-0333-02
🏷️ FDA NDC (as labeled) 76458-333-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 76458-333-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76458 labeler · 333 product · 02 package
Package marketed since
Jul 15, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7645833302 2
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76458-333-02
Product NDC 76458-333
11-digit billing NDC 76458033302
RxCUI 106309
UNII W9WZN9A0GM
Application # M006
SPL Set ID fb4cc832-4cfd-4e29-a78e-ab848681a224
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-07-15
Route TOPICAL
Dosage form LOTION
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 106309
Why two NDCs? The FDA registers this code as 76458-333-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76458-0333-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Peroxides class.

Drug family (ATC) Peroxides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzoyl Peroxide (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76458-0333-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE 2012-07-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 50 mg/mL 00536-1259-19 Rugby 236 ml $0.028 — Availability likely —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1057-75 Rugby 1 tube $0.067 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1055-25 Rugby 1 tube $0.218 — Availability likely —
Oxy 5 Vanishing 50 mg/g 10742-8355-01 The 1 bottle — — FDA listed —
Oxy 5 Tinted 50 mg/g 10742-8356-01 The 1 bottle — — FDA listed —
Anti Bac Acne Clearing 5 g/100mL 56152-4012-01 Cosmetic 50 ml — — FDA listed —
Clenziderm Therapeutic 50 mg/mL 62032-0611-01 Obagi 47 ml — — FDA listed —
Clear Cell Clarifying Acne 50 mg/g 62742-4208-01 Allure 7 g — — FDA listed —
Clear Med 5% 5 g/100mL 70764-0106-51 CONTROL 1 tube — — FDA listed —
Acne Control Serum 5 g/100g 72957-0001-01 Private 32 g — — FDA listed —
Nighttime Control 50 mg/mLthis 76458-0333-02 Circadia 1 bottle — — FDA listed —
Bubble Fade Away Acne Spot Treatment 50 mg/mL 83509-0003-01 BUBBLE 1 tube — — FDA listed —
ACNE FORTE Acne Treatment Cream 50 mg/mL 52063-0709-00 GSCM 1 jar — — FDA listed —
SERIOUS SKINCARE Continuously Clear Clearz It 50 mg/mL 53755-0392-00 Flageoli 59 ml — — FDA listed —
Acne Treatment 50 mg/mL 67226-2050-03 Vivier 1 tube — — FDA listed —
Acne Med 5% 50 mg/mL 70707-0211-15 Face 1 bottle — — FDA listed —
MD-Acne Body Acne Treatment 50 mg/mL 71804-0230-06 MD 180 ml — — FDA listed —
HUMANE Acne Spot Treatment 50 mg/mL 73010-0127-00 Apprendista, 1 tube — — FDA listed —
5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 Brand 1 tube — — FDA listed —
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 50 mg/mL 71399-9478-05 Akron 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 50090-1720-00 A-S 1 tube — — FDA listed —
Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 Walgreen 1 tube — — FDA listed —
MDacne Customized Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0536-00 MDAlgorithms 1 tube — — FDA listed —
MDacne Body Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0532-00 MDAlgorithms 90 ml — — FDA listed —
OXY Sensitive Face Wash Maximum Soothing 50 mg/mL 10742-1313-01 The 148 ml — — FDA listed —
Face Reality 5% Advanced Acne Med 50 mg/mL 70707-0157-01 Face 1 tube — — FDA listed —
OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 The 148 ml — — FDA listed —
5 Acne Med 50 mg/mL 70707-0155-15 Face 1 tube — — Discontinued —
Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 e.l.f. 1 tube — — FDA listed —
Benzoyl Peroxide Acne Medication 50 mg/mL 68071-2307-05 NuCare 42.5 ml — — FDA listed —
BLAIR and JACK Anti-Bump Acne Treatment 50 mg/mL 84377-0489-00 Blair 1 jar — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2012
On the market since
Jul 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCircadia by Dr Pugliese, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code76458
First marketedJul 2012
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Circadia by Dr Pugliese, Inc. labeler code 76458

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses for the treatment of acne

⏱️ Dosage and Administration 99 words ▾

Directions Cleanse skin thoroughly before applying Nighttime Control. Cover entire affected area with a thin layer 1 to 3 times daily. Because excessive drying of the skin may occur, start with 1 application every day, or every other day, gradually increasing to 2 or 3 times a day if needed or as directed by a doctor.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Follow directions on sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.

If going outside apply a sunscreen after using this product.

⚠️ Warnings 113 words ▾

Warnings For external use only Do not use if you When using this product have very sensitive skin are sensitive to benzoyl peroxide avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration at the same time as other topical acne medications, increased dryness or irritation is more likely to occur.

If this occurs, only one medication should be used unless directed by a doctor.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl Peroxide 5%

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Water, hexyldecanol, methyl propanediol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, cetereth-20, cetearyl glucoside, dimethicone, carbomer, tocopheryl acetate, allantoin, sodium hydroxide, caprylyl glycol, hexylene glycol, methylisothiazolinone

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if irritation becomes severe. ask a doctor before using. If pregnant or breastfeeding,

📄 Keep Out of Reach of Children 21 words ▾

Keep Out of Reach of Children In case of accidental ingestion, get medical help or contact a Poison Control Center Immediately.

📄 Questions or Comments 5 words ▾

Questions? Call toll-free (800) 630-4710

📄 Package Label / Principal Display Panel 30 words ▾

Package/Label Principal Display Panel Nighttime Control Benzoyl Peroxide Lotion Advanced Professional Skincare 2 fl oz (59 ml) Circadia by Dr. Pugliese, Inc. 8371 Route 183 Bethel, PA 19507 Circadia.com Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epsolay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Circadia by Dr Pugliese, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Circadia by Dr Pugliese, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 76458-0301-02 · Circadia 76458-0400-08 · Circadia →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.