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Sodium sulfacetamide 100 mg/mL Lotion

by Oceanside Pharmaceuticals · 1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) / 118 mL in 1 BOTTLE, PLASTIC
NDC 68682-0010-04
🏷️ FDA NDC (as labeled) 68682-010-04 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 68682-010-04
Product NDC 68682-010
11-digit billing NDC 68682001004
NCPDP billing unit ML — per mL (volume)
RxCUI 1006688
UNII 4NRT660KJQ
Application # NDA019931
SPL Set ID 6fa7399b-4ced-492d-b6f6-cf155764087a
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-18
Route TOPICAL
Dosage form LOTION
Substance SULFACETAMIDE SODIUM
GPI-14 90051036104120
GPI class Sulfacetamide Sodium (Acne)
GCN Seq No 041745
GCN 94446
HICL code 003345
Ingredient (HICL) Sulfacetamide Sodium
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name SODIUM SULFACETAMIDE 10% LOTN
FDB brand name Sulfacetamide Sodium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68682-010-04 — 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 → 68682-0010-04. 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 Sulfonamide Antibacterial class.

Pharmacologic class Sulfonamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Sulfonamides
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.

🏭 Manufacturer & labeler

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH US LLC
FDA applicationNDA019931 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio87 products on file
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.

🩺 Clinical

Label name SODIUM SULFACETAMIDE 10% LOTN Ingredient Sulfacetamide Sodium

Supplement & herbal interactions

Some supplements/herbs that may interact with sodium sulfacetamide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against sodium sulfacetamide (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.

🧪 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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $0.586 $69.14 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.6629 $78.22 / 118 ml
Medicare drug plans payPart D · Q2 2026 $0.8429 $99.46 / 118 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.936 $0.586
▼ Down 37% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sulfacetamide Sodium 100 mg/mL 45802-0896-26 Padagis 118 ml $0.585 AB Availability likely +0%
Sodium sulfacetamide 100 mg/mLthis 68682-0010-04 Oceanside 1 bottle $0.586 AB FDA listed —
Klaron 100 mg/mL 00187-5198-04 Bausch 1 bottle — AB FDA listed —
Sodium Sulfacetamide 100 mg/mL 16477-0411-08 Laser 1 bottle — — FDA listed —
Sodium Sulfacetamide 100 mg/mL 71399-1599-08 Akron 237 ml — — FDA listed —
Sodium Sulfacetamide 100 mg/mL 44523-0510-08 BioComp 237 ml — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

🗺️ 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 68682-0010-04, 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 – Q4 2025 · 4 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
2.3K
Units reimbursed last 4 qtrs
276.5K
Gross reimbursed last 4 qtrs
$183.3K
Avg / prescription
$80.32
Avg / unit
$0.6629
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.6629
gross reimbursed
vs
NADAC / mL
$0.5859
acquisition cost
=
Spread
+$0.0770
+13% vs cost
What Medicaid paid per mL (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 ⓘ
55% FFS 45% MCO
Fee-for-service · 1,260 Rx Managed care · 1,022 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,298 units · 16.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 40,238 units · 701 per 100k residents MN Wisconsin: 8,968 units · 152 per 100k residents WI Michigan: no data reported MI New York: 113,045 units · 578 per 100k residents 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: 50,504 units · 429 per 100k residents OH Pennsylvania: 1,298 units · 10.0 per 100k residents PA New Jersey: 31,978 units · 344 per 100k residents NJ Massachusetts: 1,416 units · 20.2 per 100k residents MA California: 17,228 units · 44.2 per 100k residents CA Utah: no data reported UT Colorado: 7,080 units · 120 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 2,006 units · 55.5 per 100k residents 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: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,416 units · 4.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.6701
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 Minnesota 701 /100k
2 New York 578 /100k
3 Ohio 429 /100k
4 New Jersey 344 /100k
5 Wisconsin 152 /100k
6 Colorado 120 /100k
7 Connecticut 55.5 /100k
8 California 44.2 /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.

🔬 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 Sodium Sulfacetamide — the ingredient across all brands.

Top reported reactions

Pain21
Nausea13
Condition Aggravated10
Erythema9
Fatigue9
Rash8
Somnolence8

Age at onset

Adolescent2
Adult39
Elderly8

Reporter sex

0 reports

Serious outcomes

Hospitalization25
Life-threatening6
Disabling4
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 18 4
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68682-0010-04 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) / 118 mL in 1 BOTTLE, PLASTIC 2015-12-18 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 14 words ▾

INDICATIONS Sodium Sulfacetamide Lotion is indicated in the topical treatment of acne vulgaris .

⏱️ Dosage and Administration 12 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film to affected areas twice daily.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS Sodium Sulfacetamide Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS ).

⚠️ Warnings 134 words ▾

WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity.

At the first sign of hypersensitivity, skin rash, or other reactions, discontinue use of this preparation (see ADVERSE REACTIONS ). Sodium Sulfacetamide Lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people (see CONTRAINDICATIONS ).

🤒 Adverse Reactions 110 words ▾

ADVERSE REACTIONS In controlled clinical trials for the management of acne vulgaris , the occurrence of adverse reactions associated with the use of Sodium Sulfacetamide Lotion was infrequent and restricted to local events. The total incidence of adverse reactions reported in these studies was less than 2%. Only one of 105 patients treated with Sodium Sulfacetamide Lotion had adverse reactions of erythema, itching, and edema.

It has been reported that sodium sulfacetamide may cause local irritation, stinging, and burning. While the irritation may be transient, occasionally the use of medication has to be discontinued. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 103 words ▾

Animal reproduction studies have not been conducted with Sodium Sulfacetamide Lotion. It is also not known whether Sodium Sulfacetamide Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide Lotion should be given to a pregnant woman only if clearly needed.

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. There are no adequate and well-controlled studies of Sodium Sulfacetamide Lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.

🧬 Clinical Pharmacology 156 words ▾

CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged.

The biological half-life has been reported to be between 7 to 13 hours. The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Sodium Sulfacetamide Lotion was evaluated in adult subjects (N=14) with acne vulgaris . The subjects applied Sodium Sulfacetamide Lotion to their face, back, chest, and shoulders every 12 hours for 28 days.

The percentage of the applied dose of Sodium Sulfacetamide Lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.

📦 How Supplied / Storage and Handling 30 words ▾

HOW SUPPLIED 4 fl oz (118 mL) Bottles NDC 68682-010-04 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Shake well before using. Keep tightly closed.

📋 Description 68 words ▾

DESCRIPTION Each mL of Sodium Sulfacetamide Lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of edetic acid, hydroxyethyl cellulose, lauramide DEA, methylparaben, PEG-400 monolaurate, propylene glycol, purified water, silicone emulsion, sodium chloride, sodium metabisulfite, and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is N' -[(4-amino phenyl) sulfonyl] - acetamide, monosodium salt, monohydrate.

The structural formula is: Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68682-0009-10 · Oceanside 68682-0011-10 · Oceanside →
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.