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benzoyl peroxide 5 g/100g Liquid, 227 g — NDC 45802-280-34 (Billing 45802-0280-34)

by Padagis Israel Pharmaceuticals Ltd · 227 g in 1 BOTTLE

This is a package of 227 g of benzoyl peroxide 5 g/100g Liquid from Padagis Israel Pharmaceuticals Ltd, no longer marketed (first marketed Jan 2013), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026; retail pharmacies pay about $0.0355 per g (NADAC).

NDC 45802-0280-34
🏷️ FDA NDC (as labeled) 45802-280-34 billing pads the product segment with a zero
This package
Contains227 g Cost per g$0.0355 NADAC Per package$8.06 / 227 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0556/unit — full pricing hub ↓
Product page 45802-0280-01 Also comes in: 142 g 45802-280-01
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ 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 →

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 45802-280-34 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
45802 labeler · 280 product · 34 package
Package marketed since
Jan 24, 2013
Package marketing ended
Jul 31, 2026
Sample package
No — commercial package
Billing quantity
227 g per package
Barcode (UPC)
0345802280015
Medicaid fills, this package
1,006 prescriptions in the last four reported quarters
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 Jul 2026. 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) 45802-280-34
Product NDC 45802-280
11-digit billing NDC 45802028034
NCPDP billing unit GM — per gram (weight)
RxCUI 308696
UNII W9WZN9A0GM
UPC 0345802280015
Application # M006
SPL Set ID 3146cd53-86b8-4c6f-a07f-66cdeb6cc808
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2013-01-24
Marketing end 2026-07-31
Route TOPICAL
Dosage form LIQUID
Substance BENZOYL PEROXIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90050010000905
GPI class Benzoyl Peroxide Wash
GCN Seq No 063965
GCN 99676
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 BENZOYL PEROXIDE 5% WASH
FDB brand name Benzoyl Peroxide
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 063965
  • GCN: 99676
  • GPI-14 (Medi-Span): 90050010000905
  • HICL (First Databank): 002470
  • AHFS class code: 84:28.00.00
  • RxCUI (RxNorm): 308696
Why two NDCs? The FDA registers this code as 45802-280-34 — 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 → 45802-0280-34. 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

Label name BENZOYL PEROXIDE 5% WASH Ingredient Benzoyl Peroxide
📖 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.
📖 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 $0.036 $8.06 / 227 g
Medicaid paysCMS SDUD · 12 mo $0.0556 $12.62 / 227 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.042 $0.031
▲ Up 13% over the last 15 months.
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 Per unit Per pack Marketing startMarketing endStatus
45802-0280-01 45802-280-01 Main listing 142 g in 1 BOTTLE $0.0523 / g $7.42 2013-01-24 Jul 31, 2026 Discontinued by firm
45802-0280-34 You're viewing this 227 g in 1 BOTTLE $0.0355 / g $8.06 2013-01-24 Jul 31, 2026 Discontinued by firm

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0355 NADAC).

This pack accounts for about 20% of this product's recent Medicaid fills; most go to the 142 g pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 227 g — 227 g in 1 bottle.
How does this package differ from NDC 45802-0280-01?
Both are benzoyl peroxide 5 g/100g Liquid — the drug itself is identical. This page's package is the 227 g one, while NDC 45802-0280-01 is the 142 g package. Per-g NADAC also differs: $0.0355 here vs $0.0523 for the 142 g pack.
What NDC number is used to bill for this package of benzoyl peroxide 5 g/100g 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

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 save 20%
benzoyl peroxide 5 g/100gthis 45802-0280-34 Padagis 227 g $0.036 — Discontinued —
Benzoyl Peroxide 50 mg/mL 35573-0453-08 Burel 237 ml $0.045 — Availability likely +27%
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/mL 82461-0312-05 Medcore 148 ml — — 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

🏛️
2013
On the market since
Jan 2013
📍
2026
Currently FDA-listed
13 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.

🧪 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.

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

LabelerPadagis Israel Pharmaceuticals Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code45802
First marketedJan 2013
Product typeHuman Otc Drug
Portfolio175 products on file

More NDCs from Padagis Israel Pharmaceuticals Ltd labeler code 45802

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 📄 Do Not Use 📄 When Using This Product 📄 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 ▾

Use for the treatment of acne

⏱️ Dosage and Administration 130 words ▾

Directions • shake well • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. • 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 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.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 151 words ▾

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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl peroxide 5%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

🎯 Purpose 3 words ▾

Purpose Acne medication

📄 Do Not Use 16 words ▾

Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide

📄 When Using This Product 99 words ▾

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 11 words ▾

Stop use and ask a doctor if • irritation becomes severe

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 22 words ▾

Package/Label Principal Display Panel Benzoyl Peroxide 5% Acne Medication Wash NET WT 5 OZ (142 g) Padagis ® Benzoyl Peroxide 5% Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1K
Units reimbursed last 4 qtrs
222.8K
Gross reimbursed last 4 qtrs
$12.4K
Avg / prescription
$12.32
Avg / unit
$0.0556
Latest quarter Q1 2026
24Rx
Medicaid pays / g
$0.0556
gross reimbursed
vs
NADAC / g
$0.0355
acquisition cost
=
Spread
+$0.0201
+57% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 248 Rx Managed care · 758 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 63,305 units · 631 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 14,755 units · 125 per 100k residents OH Pennsylvania: 37,565 units · 290 per 100k residents PA New Jersey: 13,194 units · 142 per 100k residents NJ Massachusetts: no data reported MA California: 55,931 units · 144 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 6,849 units · 151 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 15,613 units · 253 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 5,280 units · 180 per 100k residents MS Alabama: no data reported AL Georgia: 5,647 units · 51.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 4,658 units · 15.3 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
15.3631
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 631 /100k
2 Pennsylvania 290 /100k
3 Maryland 253 /100k
4 Mississippi 180 /100k
5 Kentucky 151 /100k
6 California 144 /100k
7 New Jersey 142 /100k
8 Ohio 125 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
142 g45802-0280-01 3,906 Rx · $38,246
227 g this page45802-0280-34 1,006 Rx · $12,397
Drug total (last 4 qtrs): 4,912 Rx · 795,011 units · $50,643 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 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 — 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) ✓ Available
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) ✓ Available
“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.
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 1 other package presentation of this same product, including 142 g (45802-0280-01). 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?
Padagis Israel Pharmaceuticals Ltd 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.
← 45802-0276-03 · Padagis 45802-0281-39 · Padagis →
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.