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Clindamycin Phosphate 10 mg/g Aerosol, Foam — NDC 63629-8629-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindamycin Phosphate 10 mg/g Aerosol, Foam — NDC 63629-8629-1 (Billing 63629-8629-01)

by Bryant Ranch Prepack · 1 CAN in 1 CARTON / 100 g in 1 CAN

This is a package of Clindamycin Phosphate 10 mg/g Aerosol, Foam from Bryant Ranch Prepack, marketed since Mar 2010 and currently FDA-listed. It is this product's only package size.

NDC 63629-8629-01
🏷️ FDA NDC (as labeled) 63629-8629-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 63629-8629-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63629 labeler · 8629 product · 1 package
Package marketed since
Mar 31, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6362986291 7
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) 63629-8629-1
Product NDC 63629-8629
11-digit billing NDC 63629862901
NCPDP billing unit GM — per gram (weight)
RxCUI 477451
UNII EH6D7113I8
Application # ANDA090785
SPL Set ID e8086cf9-aa52-4aa5-815b-c76e8f145e0b
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 2010-03-31
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

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 CLINDAMYCIN PHOSPHATE 1% FOAM
FDB brand name Clindamycin Phosphate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058418
  • GCN: 23848
  • HICL (First Databank): 004045
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 477451
Why two NDCs? The FDA registers this code as 63629-8629-1 — a 5-4-1 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 package segment → 63629-8629-01. 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 CLINDAMYCIN PHOSPHATE 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 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 $3.28 $328.00 / 100 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 Marketing startMarketing endStatus
63629-8629-01 You're viewing this Main listing 1 CAN in 1 CARTON / 100 g in 1 CAN 2010-03-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindacin 10 mg/g 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 —
Clindamycin Phosphate 10 mg/g 51672-4194-03 Sun 1 can $2.210 AT Availability likely —
Clindamycin Phosphate 10 mg/g 68462-0605-27 GLENMARK 1 can $2.210 AT Availability likely —
Clindamycin Phosphate 10 mg/g 63629-8628-01 Bryant 1 can — AT FDA listed —
Clindamycin Phosphate 10 mg/gthis 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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

LabelerBryant Ranch Prepack
Application holderPADAGIS ISRAEL PHARMACEUTICALS LTD
FDA applicationANDA090785 (ANDA)
Labeler code63629
First marketedMar 2010
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 63629

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 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

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

⏱️ Dosage and Administration 133 words ▾

2 DOSAGE AND ADMINISTRATION Clindamycin Phosphate Foam, 1% is for topical use only, and not for oral, ophthalmic or intravaginal use. Apply Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1% once daily to affected areas. ( 2 ) Flammable; avoid fire, flame and/or smoking during and immediately following application. ( 2 )

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS White to off-white thermolabile foam. Each gram of Clindamycin Phosphate Foam, 1% contains, as dispensed, 12 mg (1.2%) of clindamycin phosphate, equivalent to 10 mg (1%) of clindamycin. Foam containing 1% clindamycin as clindamycin phosphate. ( 3 )

⛔ Contraindications 57 words ▾

4 CONTRAINDICATIONS Clindamycin Phosphate Foam, 1% is contraindicated in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis). Clindamycin Phosphate Foam, 1% 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. Clindamycin Phosphate Foam, 1% 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, Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1% with eyes, mouth, lips, other mucous membranes or areas of broken skin. If contact occurs, rinse thoroughly with water. Clindamycin Phosphate Foam, 1% 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 Perrigo at 1-866-634-9120 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, 1%. The incidence of adverse reactions occurring in > 1% of the subjects in clinical trials comparing clindamycin phosphate foam, 1% 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, 1% 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, 1%.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of clindamycin phosphate foam, 1%: 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 88 words ▾

7 DRUG INTERACTIONS

7.1Erythromycin Clindamycin Phosphate Foam, 1% 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, 1% should be used with caution in patients receiving such agents.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate foam, 1%. Clindamycin Phosphate Foam, 1% should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus. Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride.

These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from clindamycin phosphate foam, 1% based on a mg/m 2 comparison.

8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate Foam, 1%. 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.

If used during lactation and Clindamycin Phosphate Foam, 1% 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, 1% in children under the age of 12 have not been studied.

8.5Geriatric Use The clinical study with clindamycin phosphate foam, 1% did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

🤰 Pregnancy 130 words ▾

8.1Pregnancy Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate foam, 1%. Clindamycin Phosphate Foam, 1% should be used during pregnancy only if the potential benefit clearly outweighs the potential risk to the fetus. Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin phosphate, clindamycin hydrochloride and clindamycin palmitate hydrochloride.

These studies revealed no evidence of fetal harm. The highest dose used in the rat and mouse teratogenicity studies was equivalent to a clindamycin phosphate dose of 432 mg/kg. For a rat, this dose is 84 fold higher, and for a mouse 42 fold higher, than the anticipated human dose of clindamycin phosphate from clindamycin phosphate foam, 1% based on a mg/m 2 comparison.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use Safety and effectiveness of clindamycin phosphate foam, 1% in children under the age of 12 have not been studied.

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use The clinical study with clindamycin phosphate foam, 1% 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 in acne vulgaris is unknown. [ See Microbiology (12.4) ]

12.2Pharmacodynamics Pharmacodynamics of Clindamycin Phosphate Foam, 1% 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, 1% 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, 1% than for the clindamycin gel, 1%. Following multiple applications of clindamycin phosphate foam, 1%, 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, 1%.

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 17 words ▾

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

📦 How Supplied / Storage and Handling 94 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Clindamycin Phosphate Foam, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is white to off-white in color and thermolabile. It is available in the following sizes: 100 gram aerosol can - NDC 63629-8629-1

16.2Storage and Handling Store at 20-25°C (68-77°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 111 words ▾

11 DESCRIPTION Clindamycin Phosphate Foam, 1% 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: Clindamycin Phosphate Foam, 1% contains clindamycin (1%) as clindamycin phosphate, 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. Image 2

💬 Information for Patients 171 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 Clindamycin Phosphate Foam, 1%. Patients should use enough Clindamycin Phosphate Foam, 1% to cover the face and to apply once daily. Patients should dispense Clindamycin Phosphate Foam, 1% directly into the cap or onto a cool surface. Patients should wash their hands after applying Clindamycin Phosphate Foam, 1%.

17.2Skin Irritation Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1% experiences severe diarrhea or gastrointestinal discomfort, Clindamycin Phosphate Foam, 1% should be discontinued and a physician should be contacted. Made in Israel Manufactured by Perrigo Yeruham, Israel Distributed by Perrigo Allegan, MI 49010 www.perrigo.com Rev 08-19 4T500 RC J4 Pharmacist-Detach here and Give Instructions to Patient

🍼 Nursing Mothers 96 words ▾

8.3Nursing Mothers It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate Foam, 1%. 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.

If used during lactation and Clindamycin Phosphate Foam, 1% is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

🧬 Pharmacokinetics 109 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, 1% 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, 1% than for the clindamycin gel, 1%. Following multiple applications of clindamycin phosphate foam, 1%, less than 0.024% of the total dose was excreted unchanged in the urine over 12 hours on Day 5.

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics Pharmacodynamics of Clindamycin Phosphate Foam, 1% is unknown.

🔬 Clinical Studies 117 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, 1% 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, 1% N = 386 Vehicle Foam N = 127 Treatment response (ISGA) 31% 18%* Percent reduction in lesion counts Inflammatory Lesions 49% 35%* Noninflammatory Lesions 38% 27%* Total Lesions 43% 31%* *P<0.05

🧪 Nonclinical Toxicology 162 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenicity of a 1.2% clindamycin phosphate gel similar to Clindamycin Phosphate Foam, 1% was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Clindamycin Phosphate Foam, 1%, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.

A 1.2% clindamycin phosphate gel similar to Clindamycin Phosphate Foam, 1% caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion 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 159 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenicity of a 1.2% clindamycin phosphate gel similar to Clindamycin Phosphate Foam, 1% was evaluated by daily application to mice for two years. The daily doses used in this study were approximately 3 and 15 times higher than the human dose of clindamycin phosphate from 5 milliliters of Clindamycin Phosphate Foam, 1%, assuming complete absorption and based on a body surface area comparison. No significant increase in tumors was noted in the treated animals.

A 1.2% clindamycin phosphate gel similar to Clindamycin Phosphate Foam, 1% caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion 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 Clindamycin Phosphate Foam, 1% Important: For skin use only. Do not use Clindamycin Phosphate Foam, 1% in your eyes, mouth or vagina. Read the Patient Information that comes with Clindamycin Phosphate Foam, 1% before you start using it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. What is Clindamycin Phosphate Foam, 1%?

Clindamycin Phosphate Foam, 1% is a prescription medicine used on the skin (topical) to treat acne in people 12 years and older. It is not known if Clindamycin Phosphate Foam, 1% is safe and effective in children under 12 years of age. Who should not use Clindamycin Phosphate Foam, 1%?

Do not use Clindamycin Phosphate Foam, 1% 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 Clindamycin Phosphate Foam, 1%? Before you use Clindamycin Phosphate Foam, 1%, tell your doctor if you: have a history of eczema are planning to have surgery.

Clindamycin Phosphate Foam, 1% may affect how certain medicines work that may be given during surgery. have any other medical conditions are pregnant or planning to become pregnant. It is not known if Clindamycin Phosphate Foam, 1% may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Clindamycin Phosphate Foam, 1% passes through your breast milk.

You and your doctor should decide if you will use Clindamycin Phosphate Foam, 1% or breastfeed. If you use Clindamycin Phosphate Foam, 1% while breastfeeding and Clindamycin Phosphate Foam, 1% is applied on the chest, take care to avoid getting Clindamycin Phosphate Foam, 1% into your baby’s mouth. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

Clindamycin Phosphate Foam, 1% may affect the way other medicines work and other medicines may affect how Clindamycin Phosphate Foam, 1% works. Especially tell your doctor if you take 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 Clindamycin Phosphate Foam, 1%? Clindamycin Phosphate Foam, 1% is for use on the skin only.

Do not get Clindamycin Phosphate Foam, 1% in your eyes, mouth or vagina. Use Clindamycin Phosphate Foam, 1% exactly as your doctor tells you to use it. See the “Instructions for Applying Clindamycin Phosphate Foam, 1%” below.

Apply Clindamycin Phosphate Foam, 1% 1 time a day. Wash your skin with mild soap and water and dry before applying Clindamycin Phosphate Foam, 1%. Do not dispense Clindamycin Phosphate Foam, 1% directly onto your hands or face, because the foam will begin to melt on contact with warm skin.

Wash your hands after applying Clindamycin Phosphate Foam, 1%. Throw away any of the unused medicine that you dispensed out of the can. What should I avoid while using Clindamycin Phosphate Foam, 1%?

Clindamycin Phosphate Foam, 1% is flammable. Avoid fire, flames, or smoking during and right after you apply Clindamycin Phosphate Foam, 1% to your skin. Avoid getting Clindamycin Phosphate Foam, 1% in or near your eyes, mouth, lips, or broken skin.

If you get Clindamycin Phosphate Foam, 1% in your eyes, mouth, on lips or broken skin, rinse well with water. What are possible side effects with Clindamycin Phosphate Foam, 1%? Clindamycin Phosphate Foam, 1% can cause serious side effects including: Inflammation of the colon (colitis).

Clindamycin can cause severe colitis that may lead to death. Stop using Clindamycin Phosphate Foam, 1% and call your doctor right away if you have severe watery diarrhea, or bloody diarrhea. The most common side effects of Cl… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 6 words ▾

Clindamycin Phosphate 1% Foam, #100 Label

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clindamycin Phosphate — the program that covers self-administered drugs. 16 manufacturers.
⚠️ 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 Clindamycin Phosphate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.9M
Claims incl. refills
181.3K
Beneficiaries
134.5K
Spend / beneficiary
$51.31
Spend / claim
$38.08
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
← 63629-8628-01 · Bryant 63629-8630-01 · Bryant →
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.