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Clindacin clindamycin phosphate 10 mg/g Aerosol, Foam — NDC 43538-0179-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindacin clindamycin phosphate 10 mg/g Aerosol, Foam — NDC 43538-179-10 (Billing 43538-0179-10)

by Medimetriks Pharmaceuticals, Inc. · 1 CAN in 1 CARTON / 100 g in 1 CAN

This is a package of Clindacin clindamycin phosphate 10 mg/g Aerosol, Foam from Medimetriks Pharmaceuticals, Inc., marketed since Mar 2010 and currently FDA-listed; retail pharmacies pay about $1.83 per g (NADAC). It is this product's only package size.

NDC 43538-0179-10
🏷️ FDA NDC (as labeled) 43538-179-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 43538-179-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
43538 labeler · 179 product · 10 package
Package marketed since
Nov 14, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4353817910 8
Medicaid fills, this package
73 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Clindamycin Phosphate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0815-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0808-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0817-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0818-2026
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0816-2026
Class III · Nov 26, 2025 — Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0257-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43538-179-10
Product NDC 43538-179
11-digit billing NDC 43538017910
NCPDP billing unit GM — per gram (weight)
RxCUI 477451, 2621717
UNII EH6D7113I8
Application # ANDA090785
SPL Set ID d01ffda3-1913-400d-a899-58b8face8936
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 2010-03-21
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance CLINDAMYCIN PHOSPHATE
TE code (Orange Book) AT · RLD · RS

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

GPI-14 90051010103905
GCN Seq No 058418
GCN 23848
HICL code 004045
Ingredient (HICL) Clindamycin Phosphate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDACIN 1% FOAM
FDB brand name Clindacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058418
  • GCN: 23848
  • GPI-14 (Medi-Span): 90051010103905
  • HICL (First Databank): 004045
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 477451
Why two NDCs? The FDA registers this code as 43538-179-10 — 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 → 43538-0179-10. 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 Lincosamide Antibacterial class.

Pharmacologic class Lincosamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Antibiotics, Lincosamides
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 CLINDACIN 1% FOAM Ingredient Clindamycin Phosphate
📖 What it is MedlinePlus · NLM

Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats serious bacterial infections, such as anaerobic infections, skin, lung, abdominal, gynecological, and bone and joint infections, depending on the product. It is often use...
  • Swallow them with a full glass of water and stay upright for at least 30 minutes afterward. This helps prevent irritation of your throat. Take it as often as your prescriber says a...
  • Rash, nausea, vomiting, stomach pain and itching are among the more commonly reported effects. Call your doctor right away if you get severe, watery or bloody diarrhea, even weeks...
  • What side effects are normal, and when should I call you?
📖 Read our full Clindamycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clindamycin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $1.831 $183.05 / 100 g
Medicaid paysCMS SDUD · 12 mo $2.63 $263.03 / 100 g
Medicare drug plans payPart D · Q2 2026 $3.72 $372.40 / 100 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $2.862 $1.831
▼ Down 36% over the last 10 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 Marketing startMarketing endStatus
43538-0179-10 You're viewing this Main listing 1 CAN in 1 CARTON / 100 g in 1 CAN 2022-11-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindacin 10 mg/gthis 43538-0179-10 Medimetriks 1 can $1.830 AT Availability likely —
Clindamycin Phosphate 10 mg/g 45802-0660-32 Padagis 1 can $2.210 AT Availability likely +21%
Clindamycin Phosphate 10 mg/g 51672-4194-03 Sun 1 can $2.210 AT Availability likely +21%
Clindamycin Phosphate 10 mg/g 68462-0605-27 GLENMARK 1 can $2.210 AT Availability likely +21%
Clindamycin Phosphate 10 mg/g 63629-8628-01 Bryant 1 can — AT FDA listed —
Clindamycin Phosphate 10 mg/g 63629-8629-01 Bryant 1 can — AT 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

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 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.

🧪 Avoiding an ingredient? See Clindamycin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

6 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

LabelerMedimetriks Pharmaceuticals, Inc.
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA090785 (ANDA)
Labeler code43538
First marketedMar 2010
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from Medimetriks Pharmaceuticals, Inc. labeler code 43538

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE Clindacin ® (clindamycin phosphate) Foam, 1% is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindacin Foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older. ( 1 )

⏱️ Dosage and Administration 125 words ▾

2 DOSAGE AND ADMINISTRATION Clindacin Foam is for topical use only, and not for oral, ophthalmic or intravaginal use. Apply Clindacin Foam once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area.

If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued. The contents of Clindacin Foam are flammable; avoid fire, flame and/or smoking during and immediately following application. For topical use only; not for oral, ophthalmic, or intravaginal use.

( 2 ) Apply Clindacin Foam once daily to affected areas. ( 2 ) Flammable; avoid fire, flame and/or smoking during and immediately following application. ( 2 )

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Clindacin Foam is a white to off-white thermolabile foam. Clindacin Foam contains 10 mg of clindamycin as clindamycin phosphate, USP per gram. Foam containing 1% clindamycin as clindamycin phosphate. ( 3 )

⛔ Contraindications 53 words ▾

4 CONTRAINDICATIONS Clindacin Foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). Clindacin Foam is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. Clindacin Foam should be discontinued if significant diarrhea occurs. ( 5.1 )

5.1Colitis Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. If significant diarrhea occurs, Clindacin Foam should be discontinued [see Adverse Reactions (6.2) ] .

Severe colitis has occurred following oral or parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

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. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2Irritation Clindacin Foam can cause irritation. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritation or dermatitis occurs, clindamycin should be discontinued.

Avoid contact of Clindacin Foam with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water. Clindacin Foam should be prescribed with caution in atopic individuals.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (>1%) are headache and application site reactions including burning, pruritus, and dryness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 439 subjects with mild to moderate acne vulgaris were treated once daily for 12 weeks with clindamycin phosphate foam. The incidence of adverse reactions occurring in ≥1% of the subjects in clinical trials comparing clindamycin phosphate foam and its vehicle is presented in Table 1.

Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Adverse Reactions Number (%) of Subjects Clindamycin Phosphate Foam N = 439 Vehicle Foam N = 154 Headache 12 (3%) 1 (1%) Application site burning 27 (6%) 14 (9%) Application site pruritus 5 (1%) 5 (3%) Application site dryness 4 (1%) 5 (3%) Application site reaction, not otherwise specified 3 (1%) 4 (3%) In a contact sensitization study, none of the 203 subjects developed evidence of allergic contact sensitization to clindamycin phosphate foam.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of clindamycin phosphate foam: application site pain, application site erythema, diarrhea, urticaria, abdominal pain, hypersensitivity, rash, abdominal discomfort, nausea, seborrhea, application site rash, dizziness, pain of skin, colitis (including pseudomembranous colitis), and hemorrhagic diarrhea. 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.

Abdominal pain and gastrointestinal disturbances, as well as gram-negative folliculitis, have also been reported in association with the use of topical formulations of clindamycin. Orally and parenterally administered clindamycin have been associated with severe colitis, which may end fatally.

🔄 Drug Interactions 86 words ▾

7 DRUG INTERACTIONS

7.1Erythromycin Clindamycin phosphate foam should not be used in combination with topical or oral erythromycin-containing products due to possible antagonism to its clindamycin component. In vitro studies have shown antagonism between these two antimicrobials. The clinical significance of this in vitro antagonism is not known.

7.2Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, clindamycin phosphate foam should be used with caution in patients receiving such agents.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with clindamycin phosphate foam. No evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (MRHD) of clindamycin phosphate foam based on body surface area (BSA) comparisons and assuming 100% absorption [see Data ] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproduction studies have been conducted in rats and mice using subcutaneous or oral doses of clindamycin phosphate, clindamycin hydrochloride or clindamycin palmitate hydrochloride administered daily during organogenesis at doses up to the equivalent of 432 mg/kg/day clindamycin phosphate. These studies produced no evidence of fetal harm or malformations in rats or mice at exposures 84 or 42 times, respectively, the MRHD of clindamycin phosphate (i.e., 5 milliliters of clindamycin phosphate foam) based on BSA comparison and assuming 100% absorption.

8.2Lactation Risk Summary There is no information on the presence of clindamycin in human milk, or the effects on the breast-fed child, or the effects on milk production following use of clindamycin phosphate foam. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin phosphate foam and any potential adverse effects on the breast-fed child from clindamycin phosphate foam or from the underlying maternal condition.

Clinical Considerations If used during lactation and clindamycin phosphate foam is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

8.4Pediatric Use Safety and effectiveness of clindamycin phosphate foam in children under the age of 12 have not been studied.

8.5Geriatric Use The clinical study with clindamycin phosphate foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

🤰 Pregnancy 209 words ▾

8.1Pregnancy Risk Summary There are no available data on clindamycin phosphate foam use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with clindamycin phosphate foam. No evidence of fetal harm or malformations was observed in pregnant rats and mice administered daily subcutaneous or oral doses of clindamycin salts during organogenesis at doses that produced exposures up to 84 and 42 times, respectively, the maximum recommended human dose (MRHD) of clindamycin phosphate foam based on body surface area (BSA) comparisons and assuming 100% absorption [see Data ] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproduction studies have been conducted in rats and mice using subcutaneous or oral doses of clindamycin phosphate, clindamycin hydrochloride or clindamycin palmitate hydrochloride administered daily during organogenesis at doses up to the equivalent of 432 mg/kg/day clindamycin phosphate. These studies produced no evidence of fetal harm or malformations in rats or mice at exposures 84 or 42 times, respectively, the MRHD of clindamycin phosphate (i.e., 5 milliliters of clindamycin phosphate foam) based on BSA comparison and assuming 100% absorption.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use Safety and effectiveness of clindamycin phosphate foam in children under the age of 12 have not been studied.

🧓 Geriatric Use 30 words ▾

8.5Geriatric Use The clinical study with clindamycin phosphate foam did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mechanism of action of clindamycin in acne vulgaris is unknown [see Microbiology (12.4) ] .

12.2Pharmacodynamics Pharmacodynamics of clindamycin phosphate foam is unknown.

12.3Pharmacokinetics In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of clindamycin phosphate foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean C max and AUC (0-12) were 23% and 9% lower, respectively, for clindamycin phosphate foam than for the clindamycin gel, 1%. Following multiple applications of clindamycin phosphate foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

12.4Microbiology No microbiology studies were conducted in the clinical trials with this product. Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. Clindamycin has been shown to have in vitro activity against Propionibacterium acnes ( P. acnes ), an organism that has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical studies with clindamycin phosphate foam.

P. acnes resistance to clindamycin has been documented. Inducible Clindamycin Resistance: The treatment of acne with antimicrobials is associated with the development of antimicrobial resistance in P. acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes ).

The use of clindamycin may result in developing inducible resistance in these organisms. This resistance is not detected by routine susceptibility testing. Cross Resistance: Resistance to clindamycin is often associated with resistance to erythromycin.

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Mechanism of action of clindamycin in acne vulgaris is unknown [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Clindacin ® (clindamycin phosphate) Foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram. The white to off-white thermolabile foam is available as follows: 100 gram aerosol can - NDC 43538- 179 -10

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Flammable. Avoid fire, flame or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C). Keep out of reach of children.

📦 Storage and Handling 54 words ▾

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Flammable. Avoid fire, flame or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C). Keep out of reach of children.

📋 Description 122 words ▾

11 DESCRIPTION Clindacin Foam contains clindamycin (1%) as clindamycin 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. The chemical name for clindamycin phosphate 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).

The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 CIN 2 O 8 PS Molecular Weight: 504.97 g/mol Clindacin Foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure

💬 Information for Patients 130 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved patient labeling (Patient Information) .

17.1Instructions for Use Patients should be advised to wash their skin with mild soap and allow it to dry before applying Clindacin Foam. Patients should use enough Clindacin Foam to cover the face and to apply once daily. Patients should dispense Clindacin Foam directly into the cap or onto a cool surface. Patients should wash their hands after applying Clindacin Foam.

17.2Skin Irritation Clindacin Foam may cause irritation such as erythema, scaling, itching, burning, or stinging. Patients should be advised to discontinue use if excessive irritancy or dermatitis occur.

17.3Colitis In the event a patient treated with Clindacin Foam experiences severe diarrhea or gastrointestinal discomfort, Clindacin Foam should be discontinued and a physician should be contacted.

🧬 Pharmacokinetics 106 words ▾

12.3Pharmacokinetics In an open label, parallel group study in 24 subjects with acne vulgaris, 12 subjects (3 male and 9 female) applied 4 grams of clindamycin phosphate foam once-daily for five days, and 12 subjects (7 male and 5 female) applied 4 grams of a clindamycin gel, 1%, once daily for five days. On Day 5, the mean C max and AUC (0-12) were 23% and 9% lower, respectively, for clindamycin phosphate foam than for the clindamycin gel, 1%. Following multiple applications of clindamycin phosphate foam, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

🧬 Pharmacodynamics 9 words ▾

12.2Pharmacodynamics Pharmacodynamics of clindamycin phosphate foam is unknown.

🔬 Clinical Studies 115 words ▾

14 CLINICAL STUDIES In one multicenter, randomized, double-blind, vehicle-controlled clinical trial, subjects with mild to moderate acne vulgaris used clindamycin phosphate foam or the vehicle foam once daily for twelve weeks. Treatment response, defined as the proportion of subjects clear or almost clear, based on the Investigator Static Global Assessment (ISGA), and the mean percent reductions in lesion counts at the end of treatment in this study are shown in Table 2. Table 2: Efficacy Results at Week 12 Efficacy Parameters Clindamycin Phosphate Foam N = 386 Vehicle Foam N = 127 Treatment response (ISGA) 31% 18% P<0.05 Percent reduction in lesion counts Inflammatory Lesions 49% 35% Noninflammatory Lesions 38% 27% Total Lesions 43% 31%

🧪 Nonclinical Toxicology 122 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenicity of a 1.2% clindamycin phosphate gel similar to clindamycin phosphate foam was evaluated by daily topical administration to mice for two years. The topical doses used in this study were approximately 3 and 15 times higher than the MRHD of clindamycin phosphate from clindamycin phosphate foam, based on BSA comparison and assuming 100% absorption. No significant increase in tumors was noted in the treated animals.

The genotoxic potential of clindamycin was evaluated in an in vitro Ames assay and in an in vivo rat micronucleus test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 119 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenicity of a 1.2% clindamycin phosphate gel similar to clindamycin phosphate foam was evaluated by daily topical administration to mice for two years. The topical doses used in this study were approximately 3 and 15 times higher than the MRHD of clindamycin phosphate from clindamycin phosphate foam, based on BSA comparison and assuming 100% absorption. No significant increase in tumors was noted in the treated animals.

The genotoxic potential of clindamycin was evaluated in an in vitro Ames assay and in an in vivo rat micronucleus test. Both tests were negative. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility.

📄 Patient Package Insert ~3 min read ▾

Patient Information Clindacin ® (klin-da-sin) (clindamycin phosphate) (klin-da-MYE-sin fos-fate) Foam, 1% Important Information: Clindacin Foam is for use on the skin only. Do not use Clindacin Foam in your eyes, mouth or vagina. What is Clindacin Foam?

Clindacin Foam is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years and older. It is not known if Clindacin Foam is safe and effective in children under 12 years of age. Who should not use Clindacin Foam?

Do not use Clindacin Foam if you: have Crohn's disease have ulcerative colitis have had inflammation of the colon (colitis) or severe diarrhea with past antibiotic use Tell your doctor if you are not sure if you have any of the conditions listed above. What should I tell my doctor before using Clindacin Foam? Before using Clindacin Foam, tell your doctor about all of your medical conditions, including if you: have or have had bowel problems (such as Crohn's disease, ulcerative colitis, colitis) have or have had eczema or other skin problems are planning to have surgery.

Clindacin Foam may affect how certain medicines work that may be given during surgery. are pregnant or plan to become pregnant. It is not known if Clindacin Foam may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if clindamycin phosphate passes into your breast milk.

Talk to your doctor about using Clindacin Foam while breastfeeding. If you use Clindacin Foam while breastfeeding and Clindacin Foam is applied on the chest, take care to avoid getting Clindacin Foam into your baby's mouth. Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements.

Clindacin Foam may affect the way other medicines work and other medicines may affect how Clindacin Foam works. Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. Know the medicines you take.

Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use Clindacin Foam? Use Clindacin Foam exactly as your doctor tells you to use it.

See the detailed " Instructions for Use " for directions about how to apply Clindacin Foam correctly. Wash your skin with mild soap and water and dry before applying Clindacin Foam. Apply Clindacin Foam 1 time each day to the affected skin area.

You should apply enough Clindacin Foam to cover the entire affected area. Dispense Clindacin Foam directly into the cap. Do not dispense Clindacin Foam directly onto your hands or face, because the foam will begin to melt on contact with warm skin.

Wash your hands after applying Clindacin Foam. What should I avoid while using Clindacin Foam? Clindacin Foam is flammable.

Avoid fire, flames, or smoking during and right after you apply Clindacin Foam to your skin. Avoid getting Clindacin Foam in or near your eyes, mouth, lips, or broken skin. If you get Clindacin Foam in your eyes, mouth, on lips or broken skin, rinse well with water.

What are possible side effects with Clindacin Foam? Clindacin Foam may cause serious side effects, including: Inflammation of the colon (colitis). Diarrhea, bloody diarrhea, and colitis has happened in people who use Clindacin Foam.

Stop using Clindacin Foam and call your doctor right away if you have severe stomach (abdominal) cramps, watery diarrhea, or bloody diarrhea during treatment, and for several weeks after treatment, with Clindacin Foam. Skin irritation. Stop using Clindacin Foam and call your doctor if you develop skin irritation during treatment with Clindacin Foam.

The most common side effects of Clindacin Foam include headache and application site reactions (including burning, itching, and dryness). These are not all the possible side effects of Clindacin Foam. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. How should I s… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~1 min read ▾

Instructions for Use Clindacin ® (klin-da-sin) (clindamycin phosphate) (klin-da-MYE-sin fos-fate) Foam, 1% Important Information: Clindacin Foam is for use on the skin only. Do not use Clindacin Foam in your eyes, mouth or vagina. Step 1: Remove the clear cap from the Clindacin Foam can.

Step 2: Hold the can upright and firmly press the nozzle to dispense Clindacin Foam into the clear cap. Dispense enough Clindacin Foam to cover the entire affected area. If the can seems warm or the foam seems runny, run the can under cold water.

Step 3: Pick up small amounts of Clindacin Foam with your fingertips and gently rub the foam into the affected area until the foam disappears. Step 4: Wash your hands after applying Clindacin Foam. Throw away any of the unused medicine that you dispensed out of the can.

How should I store Clindacin Foam? Store Clindacin Foam at room temperature between 68°F to 77°F (20°C to 25°C). Keep Clindacin Foam away from heat.

Never throw the can into a fire, even if the can is empty. Do not store Clindacin Foam at temperatures above 120°F (49°C). Do not break through (puncture) the Clindacin Foam can.

Keep Clindacin Foam and all medicines out of the reach of children. The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for: MEDIMETRIKS PHARMACEUTICALS, INC. 383 Route 46 West • Fairfield, NJ 07004-2402 US • www.medimetriks.com Manufactured by Padagis, Yeruham, Israel Iss: 04/22 IP053 4T500 EK J1 Image Image Image Image Image

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL - 100 g Can Carton NDC 43538-179-10 Rx Only Clindacin ® (Clindamycin Phosphate) Foam, 1% MEDIMETRIKS PHARMACEUTICALS, INC. 100 g PRINCIPAL DISPLAY PANEL - 100 g Can Carton

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
73
Units reimbursed last 4 qtrs
7.3K
Gross reimbursed last 4 qtrs
$19.2K
Avg / prescription
$263.03
Avg / unit
$2.6303
Latest quarter Q1 2026
32Rx
Medicaid pays / g
$2.6303
gross reimbursed
vs
NADAC / g
$1.8305
acquisition cost
=
Spread
+$0.7998
+44% 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 ⓘ
100% FFS
Fee-for-service · 73 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 7,300 units · 37.3 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: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported 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: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 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
37.337.3
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 New York 37.3 /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.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Clindacin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clindacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$9.4K
Claims incl. refills
33
Beneficiaries
19
Spend / beneficiary
$496.17
Spend / claim
$285.67
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 43538-0176-45 · Medimetriks 43538-0530-10 · Medimetriks →
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.