Home › NDC Lookup › Ingredients › Clindamycin Phosphate And Benzoyl Peroxi... › 00378-8688-35
Clindamycin Phosphate and Benzoyl Peroxide Kit — NDC 00378-8688-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindamycin Phosphate and Benzoyl Peroxide Kit — NDC 0378-8688-35 (Billing 00378-8688-35)

by Mylan Pharmaceuticals Inc. · 1 KIT in 1 CARTON * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

This is a package of Clindamycin Phosphate and Benzoyl Peroxide Kit from Mylan Pharmaceuticals Inc., marketed since Sep 2014 and currently FDA-listed; retail pharmacies pay about $0.7423 per g (NADAC).

NDC 00378-8688-35
🏷️ FDA NDC (as labeled) 0378-8688-35 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 carton * 5 g in 1 bottle, plastic * 20 g in 1 jar Cost per g$0.7423 NADAC Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.08/unit · Part D plans $1.02/unit — full pricing hub ↓
Product page 00378-8688-54 Also comes in: 1 kit 0378-8688-54
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 6, 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 0378-8688-35 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0378 labeler · 8688 product · 35 package
Package marketed since
Sep 19, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0378868835 5
Medicaid fills, this package
6,339 prescriptions in the last four reported quarters
FDA record last changed
Oct 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0378-8688-35
Product NDC 0378-8688
11-digit billing NDC 00378868835
NCPDP billing unit GM — per gram (weight)
RxCUI 308689, 358917
Application # ANDA065443
SPL Set ID 0e98ee9b-84e9-4cd8-a3ea-1247e1a510a5
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-19
Dosage form KIT
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): 308689
Why two NDCs? The FDA registers this code as 0378-8688-35 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00378-8688-35. 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
📖 What it is MedlinePlus · NLM

The combination of clindamycin and benzoyl peroxide is used to treat acne. Clindamycin and benzoyl peroxide are in a class of medications called topical antibiotics. The combination of clindamycin and benzoyl peroxide works by killing the bacteria that cause acne.

Read the full MedlinePlus article ↗

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 $0.742 —
Medicaid paysCMS SDUD · 12 mo $1.08 —
Medicare drug plans payPart D · Q2 2026 $1.02 —
NADAC price history (per g) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.166 $0.690
▼ Down 24% over the last 24 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
00378-8688-54 0378-8688-54 Main listing 1 KIT in 1 CARTON * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR $0.5007 / g — 2009-08-25 — Active
00378-8688-35 You're viewing this 1 KIT in 1 CARTON * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR $0.7423 / g — 2014-09-19 — Active

Per g, this pack runs about 48% above the cheapest pack (NDC 00378-8688-54, $0.5007 vs $0.7423 NADAC).

This pack accounts for about 35% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 carton * 5 g in 1 bottle, plastic * 20 g in 1 jar.
What NDC number is used to bill for this package of Clindamycin Phosphate and Benzoyl Peroxide Kit?
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 51672-1381-04 Sun 1 kit $0.501 AB Availability likely save 33%
Clindamycin Phosphate and Benzoyl Peroxidethis 00378-8688-35 Mylan 1 kit $0.742 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 10 mg/g; 50 mg/g 68462-0486-19 Glenmark 1 jar $0.742 AB Availability likely —
clindamycin and benzoyl peroxide 45802-0507-04 Padagis 1 kit $0.901 AB Availability likely +21%
clindamycin and benzoyl peroxide 45802-0510-03 Padagis 1 kit $1.128 AB Availability likely +52%
clindamycin and benzoyl peroxide 10 mg/g; 50 mg/g 68462-0859-24 Glenmark 1 bottle $1.128 AB Availability likely +52%
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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerMylan Pharmaceuticals Inc.
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA065443 (ANDA)
Labeler code00378
First marketedSep 2014
Product typeHuman Prescription Drug
Portfolio473 products on file

More NDCs from Mylan Pharmaceuticals Inc. labeler code 00378

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 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

⏱️ Dosage and Administration 40 words ▾

DOSAGE AND ADMINISTRATION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 42 words ▾

CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 218 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 182 words ▾

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse event in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% treatment group was dry skin (12%). The Table below lists local adverse events reported by at least 1% of patients in the Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% and vehicle groups. Local Adverse Events - all causalities in >/= 1% of patients Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% n = 420 Vehicle n = 168 Application Site Reaction 13 (3%) 1 (< 1%) Dry Skin 50 (12%) 10 (6%) Pruritis 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 134 words ▾

Pregnancy Teratogenic Effects Animal reproductive/developmental toxicity studies have not been conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%. It also is not known whether Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% was studied in male and female patients (n=13) with acne vulgaris.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/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 (0-12h) 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 urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%. 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 134 words ▾

HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS Size (Net Weight) NDC # Benzoyl Peroxide Gel Clindamycin Phosphate Solution (in plastic bottle) 25 grams 0378-8688-35 20 grams 5 grams 50 grams 0378-8688-54 40 grams 10 grams Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 1½ minutes). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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.

Store at room temperature up to 25°C (77°F) [see USP]. Do not freeze. Keep tightly closed.

Keep out of the reach of children. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Manufactured by: Kavis Pharma LLC Sugar Land, TX 77478 U.S.A. 1188.10 101033 Revised: 10/2024 KP:CLBZPX:R1

📋 Description 163 words ▾

DESCRIPTION Clindamycin Phosphate 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 504.97 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-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin Phosphate 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. Each gram of Clindamycin Phosphate 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, propylene glycol, potassium hydroxide, and purified water. Clindamycin Phosphate Structural Formula Benzoyl Peroxide Structural Formula

💬 Information for Patients ~1 min read ▾

Information for Patients Patients using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% should receive the following information and instructions: 1. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%. 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% and contact their physician immediately. In addition, patients should report any signs of local adverse reactions to their physician. 6.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% may bleach hair or colored fabric. 7. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% should receive the following information and instructions: 1.

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%.

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 Phosphate and Benzoyl Peroxide Gel, 1%/5% and contact their physician immediately.

In addition, patients should report any signs of local adverse reactions to their physician. 6. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% may bleach hair or colored fabric.

7. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%. Clindamycin phosphate was not genotoxic in Salmonella typhimurium or in a rat micronucleus test.

Clindamycin phosphate sulfoxide, an oxidative degradation product of clindamyci… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 72 words ▾

Nursing Women It is not known whether Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% was studied in male and female patients (n=13) with acne vulgaris. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% (~2g) was applied topically to the face and back twice daily for four and a half (4.5) days. Quantifiable (>LOQ=1ng/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 (0-12h) 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 urinary concentrations of clindamycin indicates that there is accumulation of clindamycin following multiple dosing of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%. 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%, 210 used benzoyl peroxide, 168 used clindamycin, and 166 used vehicle. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 Phosphate and Benzoyl Peroxide Gel, 1%/5%, based on mg/m 2 ) was statistically significantly higher than that in the sham- and vehicle-controls. Genotoxicity studies were not conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%. 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 Phosphate and Benzoyl Peroxide Gel, 1%/5% 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 grams Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5%, based on mg/m2) revealed no effects on fertility or mating ability.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – 1%/5% NDC 0378-8688-54 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%*/5% For Topical Use Only Rx only one 50 gram jar (after admixing) TO THE PHARMACIST: Important: Prior to dispensing, add the solution in the bottle to the gel and stir until homogenous in appearance (1 to 11/2 minutes). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%*/5% can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the labeling immediately following mixing.

Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%*/5% as dispensed, contains 10 mg (1%) *clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, propylene glycol, potassium hydroxide, and purified water. Usual Dosage: Apply twice daily, morning and evening, or as directed by physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry. See package insert for full prescribing information.

Use within 3 months after mixing. Store at room temperature up to 25°C (77°F) [see USP]. Do not freeze.

Keep tightly closed. Precautions: For external use only. Avoid contact with eyes.

Keep this and all medications out of the reach of children. May bleach fabric or hair. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Manufactured by: Kavis Pharma LLC Sugar Land, TX 77478 U.S.A. KP:8688:54:2C:R1 1214.5 101034 Mylan.com Clindamycin Phosphate and Benzoyl Peroxide Gel 1%/5% Carton 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
6.3K
Units reimbursed last 4 qtrs
185K
Gross reimbursed last 4 qtrs
$200.4K
Avg / prescription
$31.61
Avg / unit
$1.0829
Latest quarter Q1 2026
948Rx
Medicaid pays / g
$1.0829
gross reimbursed
vs
NADAC / g
$0.7423
acquisition cost
=
Spread
+$0.3406
+46% 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 ⓘ
27% FFS 73% MCO
Fee-for-service · 1,690 Rx Managed care · 4,649 Rx
State Medicaid map
Alaska: 1,000 units · 136 per 100k residents AK Maine: no data reported ME Washington: 10,700 units · 137 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 3,475 units · 60.6 per 100k residents MN Wisconsin: no data reported WI Michigan: 13,350 units · 133 per 100k residents MI New York: 12,350 units · 63.1 per 100k residents NY Vermont: no data reported VT New Hampshire: 425 units · 30.3 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,150 units · 35.9 per 100k residents IA Illinois: no data reported IL Indiana: 13,850 units · 202 per 100k residents IN Ohio: 39,350 units · 334 per 100k residents OH Pennsylvania: 33,595 units · 259 per 100k residents PA New Jersey: 1,275 units · 13.7 per 100k residents NJ Massachusetts: no data reported MA California: 19,005 units · 48.8 per 100k residents CA Utah: 400 units · 11.7 per 100k residents UT Colorado: 9,500 units · 162 per 100k residents CO Nebraska: 1,725 units · 87.2 per 100k residents NE Missouri: 400 units · 6.5 per 100k residents MO Kentucky: 5,500 units · 122 per 100k residents KY West Virginia: no data reported WV Virginia: 1,475 units · 16.9 per 100k residents VA Maryland: 8,325 units · 135 per 100k residents MD Connecticut: 1,625 units · 44.9 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: 2,300 units · 32.3 per 100k residents TN North Carolina: 1,625 units · 15.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 2,625 units · 57.4 per 100k residents 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.5334
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 Ohio 334 /100k
2 Pennsylvania 259 /100k
3 Indiana 202 /100k
4 Colorado 162 /100k
5 Washington 137 /100k
6 Alaska 136 /100k
7 Maryland 135 /100k
8 Michigan 133 /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.
1 kit00378-8688-54 11,843 Rx · $549,516
1 kit this page00378-8688-35 6,339 Rx · $200,362
Drug total (last 4 qtrs): 18,182 Rx · 771,130 units · $749,878 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Clindamycin Phosphate and Benzoyl Peroxide — the ingredient across all brands.

Top reported reactions

Erythema26
Acne25
Pruritus25
Rash22
Dry Skin18
Expired Product Administered16
Skin Discolouration13

Age at onset

Child1
Adolescent4
Adult23

Reporter sex

315 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization19
Disabling3
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22 1
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

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — 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 ✓ 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) ✓ 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 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 Mylan Pharmaceuticals Inc.. 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 1 kit (00378-8688-54). 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?
Mylan Pharmaceuticals Inc. 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.
← 00378-8270-52 · Mylan 00378-8760-58 · Mylan →
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.