Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
PanOxyl benzoyl peroxide 100 mg/g Cream — NDC 0316-0228-55 (Billing 00316-0228-55)
by Crown Laboratories · 1 TUBE in 1 CARTON / 156 g in 1 TUBE
This is a package of PanOxyl benzoyl peroxide 100 mg/g Cream from Crown Laboratories, no longer marketed (first marketed Mar 2011), no longer in the FDA NDC Directory.
NDC 00316-0228-55
🏷️ FDA NDC (as labeled)
0316-0228-55
billing pads the labeler segment with a zero
This package
Contains156 g in 1 tube
Pack sizes3 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 0316-0228-55 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0316 labeler · 0228 product · 55 package
- Package marketed since
- Dec 1, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0316022855 1
- 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 ↗
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0316-0228-55
Product NDC
0316-0228
11-digit billing NDC
00316022855
NCPDP billing unit
GM — per gram (weight)
RxCUI
142034
UNII
W9WZN9A0GM
Application #
M006
SPL Set ID
1660f219-e789-91f1-e063-6294a90a7664
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Apr 2024)
Marketing start
2011-03-25
Route
TOPICAL
Dosage form
CREAM
Substance
BENZOYL PEROXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90050010000910
GPI class
PanOxyl Foaming Wash
GCN Seq No
059137
GCN
24673
HICL code
002470
Ingredient (HICL)
Benzoyl Peroxide
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L5
Therapeutic class — intermediate (HIC2)
Keratolytics/Keratoplastics
HIC3 code
L5A
Therapeutic class — specific (HIC3)
Keratolytics
AHFS code
84:28.00.00
AHFS class
Keratolytic Agents
FDB label name
PANOXYL 10% ACNE FOAMING WASH
FDB brand name
Panoxyl
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 059137
- GCN: 24673
- GPI-14 (Medi-Span): 90050010000910
- HICL (First Databank): 002470
- AHFS class code: 84:28.00.00
- RxCUI (RxNorm): 142034
Why two NDCs?
The FDA registers this code as 0316-0228-55 — a 4-4-2 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 labeler segment → 00316-0228-55. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name PANOXYL 10% ACNE FOAMING WASH Ingredient Benzoyl Peroxide
📗 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.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about benzoyl peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00316-0228-01 0316-0228-01 Main listing | 1 TUBE in 1 CARTON / 28 g in 1 TUBE | 2023-01-09 | — | Discontinued by firm |
| 00316-0228-03 0316-0228-03 | 85 g in 1 TUBE | 2023-02-26 | — | Discontinued by firm |
| 00316-0228-55 You're viewing this | 1 TUBE in 1 CARTON / 156 g in 1 TUBE | 2018-12-01 | — | Discontinued by firm |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 156 g in 1 tube.
What NDC number is used to bill for this package of PanOxyl benzoyl peroxide 100 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 | Rugby | 237 g | $0.047 | — | Discontinued | — |
| Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 | Rugby | 237 g | $0.047 | — | Availability likely | — |
| Benzoyl Peroxide 100 mg/mL 35573-0454-08 | Burel | 237 ml | $0.047 | — | Availability likely | — |
| Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/mL 00536-1261-63 | Rugby | 148 ml | $0.047 | — | Availability likely | — |
| benzoyl peroxide 10 g/100g 45802-0318-01 | Padagis | 142 g | $0.048 | — | Discontinued | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/g 00536-1459-25 | Rugby | 1 tube | $0.231 | — | Availability likely | — |
| Differin Max Strength Acne Foaming BPO Cleanser 10 g/100mL 00299-4137-00 | Galderma | 1 tube | — | — | FDA listed | — |
| PanOxyl 100 mg/gthis 00316-0228-55 | Crown | 1 tube | — | — | Discontinued | — |
| Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 | Walgreen | 156 g | — | — | FDA listed | — |
| Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 | Walgreen | 142 g | — | — | FDA listed | — |
| OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/mL 10742-1202-01 | The | 148 ml | — | — | FDA listed | — |
| OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 | The | 3 g | — | — | FDA listed | — |
| OXY 10 Acne Cleanser 100 mg/mL 10742-1397-01 | The | 148 ml | — | — | FDA listed | — |
| BP Wash 100 mg/g 24470-0901-05 | CINTEX | 142 g | — | — | Discontinued | — |
| Acne Cleanser 100 mg/g 41250-0264-56 | Meijer, | 141 g | — | — | FDA listed | — |
| Acne Cleanser 100 mg/g 49035-0264-56 | Walmart, | 141 g | — | — | FDA listed | — |
| CeraVe Acne Foaming CreamWash 100 mg/mL 49967-0604-01 | L'Oreal | 1 tube | — | — | Discontinued | — |
| Replenix Acne Solutions Wash 100 mg/mL 51326-0112-01 | Topiderm, | 200 ml | — | — | FDA listed | — |
| Replenix Acne 10% Wash Paraben Free With Aloe 100 mg/mL 51326-0113-01 | Topiderm, | 200 ml | — | — | FDA listed | — |
| Dr. Zenovia Acne Cleanser 100 mg/mL 51326-0803-01 | Topiderm, | 1 bottle | — | — | FDA listed | — |
| humane acne wash 100 mg/mL 69919-0021-01 | Banner | 1 tube | — | — | FDA listed | — |
| HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide 100 mg/mL 69919-0527-08 | Banner | 1 bottle | — | — | FDA listed | — |
| MEDPURA Benzoyl Peroxide 100 mg/mL 71399-9236-05 | Akron | 148 ml | — | — | FDA listed | — |
| benzoyl peroxide 10 g/100g 72162-2337-02 | Bryant | 142 g | — | — | FDA listed | — |
| Daily Acne Control Cleanser 100 mg/g 72288-0264-56 | Amazon.com | 141 g | — | — | FDA listed | — |
| Humane Acne Wash 100 mg/mL 73010-0900-00 | Apprendista, | 237 ml | — | — | FDA listed | — |
| Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 | Guangzhou | 237 g | — | — | FDA listed | — |
| Daily Acne Control Cleanser 100 mg/g 76162-0264-28 | Topco | 141 g | — | — | FDA listed | — |
| Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 | Meijer | 1 tube | — | — | FDA listed | — |
| Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 | Wal-Mart | 1 tube | — | — | FDA listed | — |
| Benzoyl Peroxide Deep Cleansing Foaming Wash .1 g/g 80861-0112-01 | AcneFree, | 1 g | — | — | FDA listed | — |
| BENZOYL PEROXIDE 10% Topical wash 100 mg/mL 82461-0313-05 | Medcore | 148 ml | — | — | FDA listed | — |
| Replenix Acne 100 mg/g 51326-0412-57 | Topiderm, | 57 g | — | — | FDA listed | — |
| 111 Medco Benzoyl Peroxide 100 mg/g 72811-0137-11 | 111 | 113 g | — | — | FDA listed | — |
| PanOxyl Acne Clearing Spot Treatment 100 mg/g 00316-0298-01 | Crown | 1 tube | — | — | FDA listed | — |
| Clean and Clear Persa-Gel 10 100 mg/g 69968-0212-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Acne Treatment 100 mg/g 30142-0877-10 | The | 1 tube | — | — | FDA listed | — |
| Acne Treatment 100 mg/g 49035-0229-10 | Walmart | 1 tube | — | — | FDA listed | — |
| Acne Treatment 100 mg/g 76162-0229-10 | Topco | 1 tube | — | — | FDA listed | — |
| Rugby Benzoyl Peroxide Acne Medication 100 mg/g 75376-0459-25 | Guangzhou | 1 tube | — | — | FDA listed | — |
| Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1201-01 | The | 1 tube | — | — | FDA listed | — |
| Acne Treatment 100 mg/g 72288-0229-10 | Amazon.com | 1 tube | — | — | FDA listed | — |
| Signature Care Acne Medication 100 mg/g 21130-0730-17 | SAFEWAY, | 1 tube | — | — | FDA listed | — |
| CVS Health Acne Control Cleanser Acne Medication 100 mg/g 69842-0571-02 | CVS | 141 g | — | — | FDA listed | — |
| Caring mill Acne Treatment 100 mg/g 81522-0951-01 | FSA | 28 g | — | — | FDA listed | — |
| Target Up And Up Acne Medication 100 mg/g 11673-0088-17 | TARGET | 1 tube | — | — | FDA listed | — |
| Acne Treatment 100 mg/g 11822-7701-03 | Rite | 1 tube | — | — | FDA listed | — |
| Neutrogena Rapid Clear Stubborn Acne Spot 100 mg/g 69968-0043-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1205-01 | The | 2 g | — | — | FDA listed | — |
| CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment 100 mg/g 51316-0047-16 | CVS | 1 tube | — | — | FDA listed | — |
| Walgreens Maximum Strength Tinted Acne Spot Treatment Cream 100 mg/g 00363-0256-51 | WALGREEN | 1 tube | — | — | FDA listed | — |
| Walgreens Maximum Strength Acne Gel 100 mg/g 00363-0266-51 | WALGREEN | 1 tube | — | — | FDA listed | — |
| Clean and Clear persa-gel 10 Maximum Strength 100 mg/g 69968-0720-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| OXY Rapid Spot Treatment Maximum Action 100 mg/g 10742-1301-01 | The | 1 tube | — | — | FDA listed | — |
| Replenix BP Acne 100 mg/g 51326-0841-20 | Topiderm, | 57 g | — | — | FDA listed | — |
| Dermaclear Spot Treatment 100 mg/g 62742-4075-04 | Allure | 1 bottle | — | — | FDA listed | — |
| Oxy 10 Vanishing 100 mg/g 10742-8353-01 | The | 1 bottle | — | — | FDA listed | — |
| Oxy 10 Tinted 100 mg/g 10742-8354-01 | The | 1 bottle | — | — | FDA listed | — |
| Meijer Acne Treatment Acne medication 100 mg/g 41250-0347-01 | Meijer | 1 tube | — | — | FDA listed | — |
| Meijer Invisible Acne Acne medication 100 mg/g 41250-0348-01 | Meijer | 1 tube | — | — | FDA listed | — |
| Zitfree Acne Treatment 100 mg/g 67234-0035-01 | Natureplex, | 1 tube | — | — | FDA listed | — |
| Walgreens Maximum Strength Acne Treatment Acne medication 100 mg/g 00363-8798-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Walgreens Maximum Strength Acne Treatment 100 mg/g 00363-1363-17 | WALGREEN | 1 tube | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2011
On the market since
Mar 2011
📍
2026
Currently FDA-listed
15 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII Q7UI015FF9
A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
-
UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
UNII 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
-
UNII Z17H97EA6Y
A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
-
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
-
UNII F05Q2T2JA0
Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 2V16EO95H1
Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
-
UNII 13A4J4NH9I
A synthetic emulsifier derived from stearic acid and polyethylene glycol. It helps mix oil and water-based ingredients together in liquid medicines and creams to create a smooth, uniform product.
-
UNII 5965N8W85T
Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII Z6GFR7R72Y
A plant-derived cleaning agent used as a surfactant and emulsifier. It helps mix water and oil-based ingredients together and improves how the medicine spreads or is absorbed.
-
UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII MD83SFE959
A volatile organic liquid used as a solvent and preservative in medications. It helps dissolve active ingredients and other components, and can improve product stability and shelf life.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
20 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescarbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, sorbitol, stearic acid, t-butyl alcohol, xanthan gum
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerCrown Laboratories
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedMar 2011
Product typeHuman Otc Drug
Portfolio43 products on file
More NDCs from Crown Laboratories labeler code 00316
- Hydrocortisone 25 mg/g Cream NDC 0316-0193-16
- Nystatin Cream 100000 [USP'U]/g Cream NDC 0316-0221-15
- Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream NDC 0316-0223-15
- Desenex MICONAZOLE NITRATE 20 mg/g Powder NDC 0316-0225-01
- Mineral Ice Pain Relieving Menthol 20 mg/g Gel NDC 0316-0226-08
- PanOxyl benzoyl peroxide 58.7 mg/g Cream NDC 0316-0227-06
- Sarna Pramoxine Hydrochloride 10 mg/mL Lotion NDC 0316-0230-12
- Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion NDC 0316-0234-12
- Desenex Antifungal Foot Cream Miconazole Nitrate 20 mg/g Cream NDC 0316-0255-01
- Sarna Colloidal Oatmeal 20 mg/mL Lotion NDC 0316-0256-17
- PanOxyl Benzoyl Peroxide 12.6 g/113g Soap NDC 0316-0264-01
- PanOxyl Oil AM Control Moisturizer Zinc Oxide 170 mg/g Lotion NDC 0316-0269-17
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use for the treatment of acne
⏱️ Dosage and Administration ▾
Directions wet area to be cleansed apply acne wash and gently massage area for 1-2 minutes rinse thoroughly and pat dry because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
⚠️ Warnings ▾
Warnings For external use only Do not use if you have very sensitive skin are sensitive to benzoyl peroxide When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. 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. Stop use and ask a doctor if irritation becomes severe If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].
🧪 Active Ingredient ▾
Active ingredient Benzoyl peroxide 10%
🧪 Inactive Ingredients ▾
Inactive ingredients carbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, sorbitol, stearic acid, t-butyl alcohol, xanthan gum
🎯 Purpose ▾
Purpose Acne medication
📄 Do Not Use ▾
Do not use if you have very sensitive skin are sensitive to benzoyl peroxide
📄 When Using This Product ▾
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. 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.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if irritation becomes severe
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? call 1-833-279-6522
📄 Package Label / Principal Display Panel ▾
Panoxyl 10% Tube PanOxyl® ACNE FOAMING WASH for Face & Body 10% Benzoyl Peroxide Acne Treatment Wash Maximum Strength Clears existing acne and helps prevent new breakouts Net wt. 5.5oz (156g) DERMATOLOGIST RECOMMENDED Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 P11536.04 P11536.04 Tube
Panoxyl 10% Carton PanOxyl® ACNE FOAMING WASH for Face & Body 10% Benzoyl Peroxide Acne Treatment Wash Maximum Strength Clears existing acne and helps prevent new breakouts Maximum strength without a prescription No.1 DERMATOLOGIST RECOMMENDED BENZOYL PEROXIDE BRAND Net wt. 5.5oz (156g) P11731.05 10pct carton
No label section mentions that — try another word, or open the full label on DailyMed below.
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.
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PanOxyl (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
About this NDC listing & data coverage
Over-the-counter (OTC) product
No longer marketed (per FDA listing data)
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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (00316-0228-01), 85 g (00316-0228-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Crown Laboratories 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.
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.