Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
BENZOYL PEROXIDE 5% Topical wash 50 mg/mL Liquid, 148 mL — NDC 82461-312-05 (Billing 82461-0312-05)
by Medcore LLC · 148 mL in 1 BOTTLE, PUMP
This is a package of 148 mL of BENZOYL PEROXIDE 5% Topical wash 50 mg/mL Liquid from Medcore LLC, marketed since Oct 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 82461-0312-05
🏷️ FDA NDC (as labeled)
82461-312-05
billing pads the product segment with a zero
This package
Contains148 mL
Pack sizes2 compare ↓
Main listing for product 82461-312 · Also comes in:
236 ml 82461-312-08
🗂️ FDA directory synced Oct 8, 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 82461-312-05 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 82461 labeler · 312 product · 05 package
- Package marketed since
- Oct 20, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 148 mL per package
- Barcode (UPC)
- 0382461313050, 0382461312053
- 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)
82461-312-05
Product NDC
82461-312
11-digit billing NDC
82461031205
NCPDP billing unit
ML — per mL (volume)
UNII
W9WZN9A0GM
UPC
0382461313050, 0382461312053
Application #
M006
SPL Set ID
14bf3034-2fe8-44b9-9e26-e804b6046837
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-10-20
Route
TOPICAL
Dosage form
LIQUID
Substance
BENZOYL PEROXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90050010000905
Quick answers
- GPI-14 (Medi-Span): 90050010000905
- RxCUI (RxNorm): 142034
Why two NDCs?
The FDA registers this code as 82461-312-05 — 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 → 82461-0312-05. 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 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 8, 2026
Clinical
📖 What it is MedlinePlus · NLM
Benzoyl peroxide is used to treat mild to moderate acne.
Read the full MedlinePlus article ↗📗 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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 mL | 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
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.
Try another pack size:
236 ml
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 9, 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 |
|---|---|---|---|---|
| 82461-0312-05 You're viewing this Main listing | 148 mL in 1 BOTTLE, PUMP | 2025-10-20 | — | Active |
| 82461-0312-08 82461-312-08 | 236 mL in 1 BOTTLE, PUMP | 2025-10-20 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This package contains 148 mL — 148 ml in 1 bottle, pump.
How does this package differ from NDC 82461-0312-08?
Both are BENZOYL PEROXIDE 5% Topical wash 50 mg/mL Liquid — the drug itself is identical. This page's package is the 148 mL one, while NDC 82461-0312-08 is the 236 ml package.
What NDC number is used to bill for this package of BENZOYL PEROXIDE 5% Topical wash 50 mg/mL Liquid?
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 50 mg/mL 00536-1259-19 | Rugby | 236 ml | $0.028 | — | Availability likely | — |
| Benzoyl Peroxide 50 mg/mL 35573-0453-08 | Burel | 237 ml | $0.045 | — | Availability likely | — |
| benzoyl peroxide 5 g/100g 45802-0280-01 | Padagis | 142 g | $0.052 | — | Discontinued | — |
| Differin Daily Deep Cleanser with BPO 5 g/100mL 00299-4606-00 | Galderma | 1 tube | — | — | FDA listed | — |
| Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Oxy Sensitive Skin Acne Cream Cleanser 50 mg/mL 10742-1004-01 | The | 148 ml | — | — | FDA listed | — |
| OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 | The | 148 ml | — | — | FDA listed | — |
| OXY Sensitive Face Wash Maximum Soothing 50 mg/mL 10742-1313-01 | The | 148 ml | — | — | FDA listed | — |
| SPOTLESS Daily Acne Wash .05 g/mL 14222-1610-01 | Rodan | 1 tube | — | — | FDA listed | — |
| BP Wash 50 mg/g 24470-0900-04 | CINTEX | 113 g | — | — | FDA listed | — |
| REPLENIX ACNE Solution BENZOYL PEROXIDE WASH 50 mg/mL 51326-0111-01 | Topiderm, | 200 ml | — | — | FDA listed | — |
| Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7300-01 | Cosco | 1 tube | — | — | FDA listed | — |
| Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7301-01 | Cosco | 1 tube | — | — | FDA listed | — |
| PCA SKIN BPO Cleanser 5 g/100mL 68726-0168-04 | CP | 1 bottle | — | — | FDA listed | — |
| HUMANE Acne Wash 5 50 mg/mL 69919-0526-08 | Banner | 1 bottle | — | — | FDA listed | — |
| MEDPURA Benzoyl Peroxide 50 mg/mL 71399-9234-05 | Akron | 148 ml | — | — | FDA listed | — |
| benzoyl peroxide 5 g/100g 72162-2338-02 | Bryant | 142 g | — | — | FDA listed | — |
| BP Body Wash 50 mg/g 73318-7005-01 | Skin | 1 tube | — | — | FDA listed | — |
| Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 | e.l.f. | 1 tube | — | — | FDA listed | — |
| 5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 | Brand | 1 tube | — | — | FDA listed | — |
| BENZOYL PEROXIDE 5% Topical wash 50 mg/mLthis 82461-0312-05 | Medcore | 148 ml | — | — | FDA listed | — |
| SkinPharmacy Advanced Acne Therapy Spot Treatment 50 mg/mL 69842-0023-01 | CVS | 1 tube | — | — | FDA listed | — |
| Dr. Zenovia Spot Treatment 50 mg/mL 51326-0802-01 | Topiderm, | 1 bottle | — | — | FDA listed | — |
| Bubble Fade Away Acne Spot Treatment 50 mg/mL 83509-0003-01 | BUBBLE | 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 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 9, 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.
🧪 Avoiding an ingredient? See Benzoyl Peroxide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
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 RD25J5V947
A waxy mixture derived from vegetable oils and polyethylene glycol that helps emulsify and blend oil-based and water-based ingredients. It's used in creams and lotions to create a smooth, uniform texture and improve product stability.
-
UNII OAH19558U1
A synthetic compound made from coconut oil, laureth-12 helps mix oil and water-based ingredients together. It acts as an emulsifier and surfactant in formulations, improving how the medicine spreads and is absorbed.
-
UNII 6M3P64V0NC
A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
-
UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 3599J29ANH
A cleansing agent derived from coconut oil. It helps break down and mix oil and water in the formulation, and may aid in dispersing the active ingredient throughout the product.
-
UNII SLK428451L
Sodium lauroamphoacetate is a mild cleaning agent derived from coconut oil. It acts as a surfactant and emulsifier in medicines, helping blend water and oil-based ingredients together and improving how the product spreads or dissolves.
-
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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL
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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerMedcore LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code82461
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio23 products on file
More NDCs from Medcore LLC labeler code 82461
- BENZOYL PEROXIDE 10% Topical wash 100 mg/mL Liquid NDC 82461-313-05
- Methyl Salicylate 10 g/100g Patch NDC 82461-414-10
- Methyl Salicylate 25% Cream 250 mg/mL Cream NDC 82461-415-05
- Lidocaine Patch 4% 40 mg/g Patch NDC 82461-416-30
- Capsaicin 0.035% cream .35 mg/mL Cream NDC 82461-417-10
- Capsaicin 0.03% Patch .03 g/100g Patch NDC 82461-418-10
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 8, 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
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For the treatment of acne
⏱️ Dosage and Administration ▾
Directions adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor
⚠️ Warnings ▾
Warnings For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen.
Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. 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 lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.
📦 Storage and Handling ▾
Other information Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.
🧪 Active Ingredient ▾
Active ingredient BENZOYL PEROXIDE 5% or 10% Purpose Acne medication
🧪 Inactive Ingredients ▾
Inactive Ingredients CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL
🎯 Purpose ▾
Purpose Acne medication
📄 Do Not Use ▾
- allergic reaction occurs - condition worsens or does not improve within 7 days - symptoms clear up and return within a few days - redness, irritation, swelling, pain or other symptoms begin or increase
📄 When Using This Product ▾
INSTRUCTIONS FOR USE Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, one application daily, then gradually increase to two or three 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
📄 Keep Out of Reach of Children ▾
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 5% 5 OZ Bottle Label NDC: 82461-312-05 Medcore LLC BENZOYL PEROXIDE 5% Acne wash 5 OZ Manufactured For: Medcore LLC 3048 Valley Rd. Basking Ridge, NJ 07920 Questions or Comments Please call 908-280-2269 Label-1
PRINCIPAL DISPLAY PANEL - 5% 8 OZ Bottle Label NDC: 82461-312-08 Medcore LLC BENZOYL PEROXIDE 5% Acne wash 8 OZ Manufactured For: Medcore LLC 3048 Valley Rd. Basking Ridge, NJ 07920 Questions or Comments Please call 908-280-2269 Label-1
PRINCIPAL DISPLAY PANEL - 10% 5 OZ Bottle Label NDC: 82461-313-05 Medcore LLC BENZOYL PEROXIDE 10% Acne wash 5 OZ Manufactured For: Medcore LLC 3048 Valley Rd. Basking Ridge, NJ 07920 Questions or Comments Please call 908-280-2269 Label-1
PRINCIPAL DISPLAY PANEL - 10% 8 OZ Bottle Label NDC: 82461-313-08 Medcore LLC BENZOYL PEROXIDE 10% Acne wash 8 OZ Manufactured For: Medcore LLC 3048 Valley Rd. Basking Ridge, NJ 07920 Questions or Comments Please call 908-280-2269 Label-1
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 BENZOYL PEROXIDE — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 23%
Female · 76%
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
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.
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 Medcore LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 236 ml (82461-0312-08). 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?
Medcore LLC 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.