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clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel — NDC 68462-0486-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel — NDC 68462-486-24 (Billing 68462-0486-24)

by Glenmark Pharmaceuticals Inc., USA · 1 JAR in 1 CARTON / 35 g in 1 JAR

This is a package of clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel from Glenmark Pharmaceuticals Inc., USA, marketed since Mar 2019 and currently FDA-listed.

NDC 68462-0486-24
🏷️ FDA NDC (as labeled) 68462-486-24 billing pads the product segment with a zero
This package
Contains35 g in 1 jar Pack sizes3 compare ↓
Also priced by: Part D plans $1.02/unit — full pricing hub ↓
Product page 68462-0486-27 Also comes in: 25 g 68462-486-19 50 g 68462-486-27
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 68462-486-24 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68462 labeler · 486 product · 24 package
Package marketed since
May 7, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0368462859247, 0368462857861, 0368462484692, 0368462484869 +1 more
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-486-24
Product NDC 68462-486
11-digit billing NDC 68462048624
NCPDP billing unit GM — per gram (weight)
RxCUI 358917
UNII W9WZN9A0GM, EH6D7113I8
UPC 0368462859247, 0368462857861, 0368462484692, 0368462484869 +1 more
Application # ANDA209252
SPL Set ID 76795d1b-e1f2-4d1d-b42a-f1d4448c63c0
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-14
Route TOPICAL
Dosage form GEL
Substance CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90059902194020
GPI class Clindamycin Phos-Benzoyl Perox
GCN Seq No 037628
GCN 08205
HICL code 017263
Ingredient (HICL) Clindamycin Phos/Benzoyl Perox
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 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDAMYCIN-BENZOYL PEROX 1-5%
FDB brand name Clindamycin-Benzoyl Peroxide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 037628
  • GCN: 08205
  • GPI-14 (Medi-Span): 90059902194020
  • HICL (First Databank): 017263
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 358917
Why two NDCs? The FDA registers this code as 68462-486-24 — 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 → 68462-0486-24. 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 CLINDAMYCIN-BENZOYL PEROX 1-5% Ingredient Clindamycin Phos/Benzoyl Perox

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.02 $35.58 / 35 g
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
68462-0486-19 68462-486-19 1 JAR in 1 CARTON / 25 g in 1 JAR $0.7423 / g $18.56 2019-03-14 — Active
68462-0486-24 You're viewing this 1 JAR in 1 CARTON / 35 g in 1 JAR — — 2019-05-07 — Active
68462-0486-27 68462-486-27 Main listing 1 JAR in 1 CARTON / 50 g in 1 JAR $0.5007 / g $25.04 2019-03-14 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 35 g in 1 jar.
What NDC number is used to bill for this package of clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g Gel?
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
Clindamycin Phosphate and Benzoyl Peroxide 00378-8688-54 Mylan 1 kit $0.501 AB Availability likely —
Clindamycin Phosphate and Benzoyl Peroxide 51672-1381-04 Sun 1 kit $0.501 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 16714-0984-25 NorthStar 1 jar $0.742 AB Availability likely —
Clindamycin and Benzoyl Peroxide 21922-0068-43 Encube 1 kit $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0509-01 Padagis 1 kit $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0507-04 Padagis 1 kit $0.901 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0510-03 Padagis 1 kit $1.128 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 68462-0859-24 Glenmark 1 bottle $1.128 AB Availability likely —
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/gthis 68462-0486-24 Glenmark 1 jar — AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 50 mg/g 70771-1450-04 Zydus 1 tube — AB FDA listed —
Clindamycin And Benzoyl Peroxide 72162-2074-02 Bryant 1 kit — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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 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 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 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 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

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.

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

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK SPECIALTY SA
FDA applicationANDA209252 (ANDA)
Labeler code68462
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio343 products on file

More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 38 words ▾

DOSAGE AND ADMINISTRATION Clindamycin and Benzoyl Peroxide Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.

⛔ Contraindications 40 words ▾

CONTRAINDICATIONS Clindamycin and Benzoyl Peroxide Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. It is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

⚠️ Warnings 217 words ▾

WARNINGS ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA, BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC CLINDAMYCIN.

STUDIES INDICATE A TOXIN(S) PRODUCED BY CLOSTRIDIA IS ONE PRIMARY CAUSE OF ANTIBIOTIC-ASSOCIATED COLITIS. THE COLITIS IS USUALLY CHARACTERIZED BY SEVERE PERSISTENT DIARRHEA AND SEVERE ABDOMINAL CRAMPS AND MAY BE ASSOCIATED WITH THE PASSAGE OF BLOOD AND MUCUS. ENDOSCOPIC EXAMINATION MAY REVEAL PSEUDOMEMBRANOUS COLITIS.

STOOL CULTURE FOR Clostridium Difficile AND STOOL ASSAY FOR C. difficile TOXIN MAY BE HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF SEVERE DIARRHEA.

ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE CONDITION. DIARRHEA, COLITIS, AND PSEUDOMEMBRANOUS COLITIS HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

🤒 Adverse Reactions 168 words ▾

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the clindamycin and benzoyl peroxide gel treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the clindamycin and benzoyl peroxide gel and vehicle groups. Local Adverse Events – all causalities in >/= 1% of patients Clindamycin and Benzoyl Peroxide n=420 Vehicle n=168 Application site reaction 13 (3%) 1 (<1%) Dry skin 50 (12%) 10 (6%) Pruritus 8 (2%) 1 (<1%) Peeling 9 (2%) - Erythema 6 (1%) 1 (<1%) Sunburn 5 (1%) - The actual incidence of dry skin might have been greater were it not for the use of a moisturizer in these studies.

Anaphylaxis, as well as allergic reactions leading to hospitalization, have been reported during post-marketing use of clindamycin/benzoyl peroxide products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

🤰 Pregnancy 129 words ▾

Pregnancy: Teratogenic Effects: Animal reproductive/developmental toxicity studies have not been conducted with clindamycin and benzoyl peroxide gel or benzoyl peroxide. Developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg/m 2 , respectively) revealed no evidence of teratogenicity.

There are no well-controlled trials in pregnant women treated with Clindamycin and Benzoyl Peroxide Gel . It also is not known whether Clindamycin and Benzoyl Peroxide Gel can cause fetal harm when administered to a pregnant woman.

🧒 Pediatric Use 20 words ▾

Pediatric Use: Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY An in vitro percutaneous penetration study comparing Clindamycin and Benzoyl Peroxide Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in Clindamycin and Benzoyl Peroxide Gel is suggested to be less than 1%. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle. Pharmacokinetics: The pharmacokinetics (plasma and urine) of clindamycin from Clindamycin and Benzoyl Peroxide Gel was studied in male and female patients (n=13) with acne vulgaris.

Clindamycin and Benzoyl Peroxide Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1 ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5. Peak plasma concentrations (C max ) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5.

The AUC (0 to 12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5. The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5. The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04).

A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of Clindamycin and Benzoyl Peroxide Gel . The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold. Microbiology: The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.

📦 How Supplied / Storage and Handling 195 words ▾

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS NDC Number Size (Net Weight) Benzoyl Peroxide Gel (in a jar) *includes pump Active Clindamycin powder (in plastic vial) Purified Water to be added to each vial 68462-486-19 19.7 g (68462-485-19) 0.3 g (68462-484-69) 5 mL 68462-485-24 35 g Carton 27.6 g (68462-485-24) 0.4 g (68462-484-98) 7 mL 68462-486-27 50 g Carton 39.4 g (68462-485-27) 0.6 g (68462-484-86) 10 mL 68462-859-24 35 g Pump Carton 27.6* (68462-858-24) 0.4 g (68462-857-98) 7 mL 68462-859-27 50 g Pump Carton 39.4* (68462-858-27) 0.6 g (68462-857-86) 10 mL Prior to dispensing, tap the vial until powder flows freely.

Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes).

For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and Benzoyl Peroxide Gel (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.

📦 Storage and Handling 54 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep tightly closed. Keep out of reach of children. Rx Only Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025 logo

📋 Description 165 words ▾

DESCRIPTION Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS).

The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.96 g/mol and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo - α -D- galacto -octopyranoside 2-(dihydrogen phosphate). Clindamycin and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ).

It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23 g/mol. Each gram of Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, docusate sodium, edetate disodium, sodium hydroxide and purified water. clinidamycin-structure benzoyl-peroxide

💬 Information for Patients ~1 min read ▾

Information for Patients: Patients using Clindamycin and Benzoyl Peroxide Gel should receive the following information and instructions: 1. Clindamycin and Benzoyl Peroxide Gel is to be used as directed by the physician. It is for external use only.

Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. Patients should not use any other topical acne preparation unless otherwise directed by physician. 4.

Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using clindamycin and benzoyl peroxide gel. To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used. 5.

Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue Clindamycin and Benzoyl Peroxide Gel and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician. 6.

Clindamycin and Benzoyl Peroxide Gel may bleach hair or colored fabric. 7. Clindamycin and Benzoyl Peroxide Gel can be stored at room temperature up to 25°C (77°F) for 3 months.

Do not freeze. Discard any unused product after 3 months. 8.

Before applying Clindamycin and Benzoyl Peroxide Gel to affected areas wash the skin gently, then rinse with warm water and pat dry.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: For dermatological use only; not for ophthalmic use. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. The use of antibiotic agents may be associated with the overgrowth of non-susceptible organisms including fungi.

If this occurs, discontinue use of this medication and take appropriate measures. Avoid contact with eyes and mucous membranes. Clindamycin and erythromycin containing products should not be used in combination.

In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known. Information for Patients: Patients using Clindamycin and Benzoyl Peroxide Gel should receive the following information and instructions: 1.

Clindamycin and Benzoyl Peroxide Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes, and inside the nose, mouth, and all mucous membranes, as this product may be irritating.

2. This medication should not be used for any disorder other than that for which it was prescribed. 3.

Patients should not use any other topical acne preparation unless otherwise directed by physician. 4. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using clindamycin and benzoyl peroxide gel.

To minimize exposure to sunlight, a wide-brimmed hat or other protective clothing should be worn, and a sunscreen with SPF 15 rating or higher should be used. 5. Patients who develop allergic symptoms such as severe swelling or shortness of breath should discontinue Clindamycin and Benzoyl Peroxide Gel and contact their physician immediately.

In addition, patients should report any signs of local adverse reactions to their physician. 6. Clindamycin and Benzoyl Peroxide Gel may bleach hair or colored fabric.

7. Clindamycin and Benzoyl Peroxide Gel can be stored at room temperature up to 25°C (77°F) for 3 months. Do not freeze.

Discard any unused product after 3 months. 8. Before applying Clindamycin and Benzoyl Peroxide Gel to affected areas wash the skin gently, then rinse with warm water and pat dry.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of clindamycin and benzoyl peroxide gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation). In a 2-year dermal carcinogenicity study in rats, treatment with clindamycin and benzoyl peroxide gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats.

The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide gel, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with clindamycin and benzoyl peroxide gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 70 words ▾

Nursing Women: It is not known whether Clindamycin and Benzoyl Peroxide Gel is excreted in human milk after topical application. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics: The pharmacokinetics (plasma and urine) of clindamycin from Clindamycin and Benzoyl Peroxide Gel was studied in male and female patients (n=13) with acne vulgaris. Clindamycin and Benzoyl Peroxide Gel (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1 ng/mL) clindamycin plasma concentrations were obtained in six of thirteen subjects (46.2%) on Day 1 and twelve of thirteen subjects (92.3%) on Day 5.

Peak plasma concentrations (C max ) of clindamycin ranged from 1.47 ng/mL to 2.77 ng/mL on Day 1 and 1.43 ng/mL to 7.18 ng/mL on Day 5. The AUC (0 to 12h) ranged from 2.74 ng.h/mL to 12.86 ng.h/mL on Day 1 and 11.4 ng.h/mL to 69.7 ng.h/mL on Day 5. The amount of clindamycin excreted in the urine during the 12 hour dosing interval increased from a mean (SD) of 5745 (3130) ng on Day 1 to 12069 (7660) ng on Day 5.

The mean % (SD) of the administered dose that was excreted in the urine ranged from 0.03% (0.02) to 0.08% (0.04). A comparison of the single (Day 1) and multiple (Day 5) dose plasma and urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of Clindamycin and Benzoyl Peroxide Gel . The degree of accumulation calculated from the plasma and urinary excretion data was ~2-fold.

🔬 Clinical Studies ~1 min read ▾

CLINICAL STUDIES In two adequate and well controlled clinical studies of 758 patients, 214 used clindamycin and benzoyl peroxide gel, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. Clindamycin and benzoyl peroxide gel applied twice daily for 10 weeks was significantly more effective than vehicle in the treatment of moderate to moderately severe facial acne vulgaris. Patients were evaluated and acne lesions counted at each clinical visit; weeks 2, 4, 6, 8 and 10.

The primary efficacy measures were the lesion counts and the investigator’s global assessment evaluated at week 10. Patients were instructed to wash the face with a mild soap, using only the hands. Fifteen minutes after the face was thoroughly dry, application was made to the entire face.

Non-medicated make-up could be applied at one hour after the clindamycin and benzoyl peroxide gel application. If a moisturizer was required, the patients were provided a moisturizer to be used as needed. Patients were instructed to avoid sun exposure.

Percent reductions in lesion counts after treatment for 10 weeks in these two studies are shown below: Study 1 Clindamycin and Benzoyl Peroxide n = 120 Benzoyl Peroxide n = 120 Clindamycin n = 120 Vehicle n = 120 Mean percent reduction in inflammatory lesion counts 46% 32% 16% +3% Mean percent reduction in non-inflammatory lesion counts 22% 22% 9% +1% Mean percent reduction in total lesion counts 36% 28% 15% 0.2% Study 2 Clindamycin and Benzoyl Peroxide n = 95 Benzoyl Peroxide n = 95 Clindamycin n = 49 Vehicle n = 48 Mean percent reduction in inflammatory lesion counts 63% 53% 45% 42% Mean percent reduction in non-inflammatory lesion counts 54% 50% 39% 36% Mean percent reduction in total lesion counts 58% 52% 42% 39% The clindamycin and benzoyl peroxide gel group showed greater overall improvement than the benzoyl peroxide, clindamycin and vehicle groups as rated by the investigator.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. The clinical significance of this is unknown. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced skin tumors in transgenic Tg.AC mice in a study using 20 weeks of topical treatment.

In a 52 week dermal photocarcinogenicity study in hairless mice, the median time to onset of skin tumor formation was decreased and the number of tumors per mouse increased following chronic concurrent topical administration of clindamycin and benzoyl peroxide gel with exposure to ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation). In a 2-year dermal carcinogenicity study in rats, treatment with clindamycin and benzoyl peroxide gel at doses of 100, 500 and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats.

The incidence of keratoacanthoma at the treated site of males treated with 2000 mg/kg/day (8 times the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide gel, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with clindamycin and benzoyl peroxide gel. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamycin phosphate and benzoyl peroxide, was not clastogenic in a mouse micronucleus test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Studies have not been performed with Clindamycin and Benzoyl Peroxide Gel or benzoyl peroxide to evaluate the effect on fertility.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g clindamycin and benzoyl peroxide gel, based on mg/m 2 ) revealed no effects on fertility or mating ability.

📄 Package Label / Principal Display Panel 45 words ▾

Label Display Panel – 25 gram Kit Carton 25g-carton

Label Display Panel - 35 gram Kit Carton 35g-carton

Label Display Panel – 50 gram Kit Carton 50g-carton

PRINCIPAL DISPLAY PANEL – 35 g Pump Pack pump35mg

PRINCIPAL DISPLAY PANEL – 50 g Pump Pack pump50mg

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

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.
1 jar68462-0486-27 12,867 Rx · $534,642
1 jar68462-0486-19 7,652 Rx · $234,292
1 jar this page68462-0486-24 No Medicaid data
Drug total (last 4 qtrs): 20,519 Rx · 842,750 units · $768,934 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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

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 Glenmark Pharmaceuticals Inc., USA. 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 2 other package presentations of this same product, including 1 jar (68462-0486-19), 1 jar (68462-0486-27). 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?
Glenmark Pharmaceuticals Inc., USA 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 68462-0480-39 · Glenmark 68462-0494-30 · Glenmark →
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.