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Cleocin T clindamycin phosphate 10 mg/mL Solution — NDC 0009-3116-01 (Billing 00009-3116-01)

by Pharmacia & Upjohn Company LLC · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Cleocin T clindamycin phosphate 10 mg/mL Solution from Pharmacia & Upjohn Company LLC, no longer marketed, no longer in the FDA NDC Directory. It is this product's only package size.

NDC 00009-3116-01
🏷️ FDA NDC (as labeled) 0009-3116-01 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2019. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0009-3116-01
Product NDC 0009-3116
11-digit billing NDC 00009311601
NCPDP billing unit ML — per mL (volume)
Application # NDA050537
SPL Set ID 4a3901a4-194f-4a15-9c85-3d0982afcf31
Physiologic effect Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2019)
Route TOPICAL
Dosage form SOLUTION
Substance CLINDAMYCIN PHOSPHATE

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

GCN Seq No 007727
GCN 31720
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 CLEOCIN T 1% SOLUTION
FDB brand name Cleocin T
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007727
  • GCN: 31720
  • HICL (First Databank): 004045
  • AHFS class code: 08:12.28.20
Why two NDCs? The FDA registers this code as 0009-3116-01 — 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 → 00009-3116-01. 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.

Clinical

Label name CLEOCIN T 1% SOLUTION Ingredient Clindamycin Phosphate
📗 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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
00009-3116-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 1980-06-20 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cleocin T 10 mg/mLthis 00009-3116-01 Pharmacia 1 bottle — — Discontinued —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPharmacia & Upjohn Company LLC
Application holderPFIZER INC
FDA applicationNDA050537 (NDA)
Labeler code00009
Product typeHuman Prescription Drug
Portfolio106 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

INDICATIONS AND USAGE CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).

⏱️ Dosage and Administration 108 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of, CLEOCIN T Topical Lotion, CLEOCIN T Topical Gel, CLEOCIN T Topical Solution, or use a CLEOCIN T Topical Solution pledget for the application of CLEOCIN T twice daily to affected area. More than one pledget may be used. Each pledget should be used only once and then be discarded.

CLEOCIN T Topical Solution is flammable. Avoid fire, flame, and smoking during and immediately following application. Lotion: Shake well immediately before using.

Pledget: Remove pledget from foil just before use. Do not use if the seal is broken. Discard after single use.

Keep all liquid dosage forms in containers tightly closed.

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

⚠️ Warnings ~1 min read ▾

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 systemic absorption 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 Clostridioides 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. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridioides difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.

Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

🤒 Adverse Reactions 189 words ▾

ADVERSE REACTIONS In 18 clinical studies of various formulations of CLEOCIN T using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Events Treatment Emergent Adverse Event Solution n=553(%) Gel n=148(%) Lotion n=160(%) # not recorded Burning 62 (11) 15 (10) 17 (11) Itching 36 ( 7) 15 (10) 17 (11) Burning/Itching 60 (11) # ( – ) # ( – ) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 ( 7) 22 (14) Oiliness/Oily Skin 8 ( 1) 26 (18) 12 of 126 subjects (10) Peeling 61 (11) # ( – ) 11 ( 7) Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

🔄 Drug Interactions 33 words ▾

Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

🤰 Pregnancy 59 words ▾

Pregnancy: Teratogenic Effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

🧒 Pediatric Use 17 words ▾

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

🧓 Geriatric Use 43 words ▾

Geriatric Use Clinical studies for CLEOCIN T did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 18 words ▾

OVERDOSAGE Topically applied CLEOCIN T can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).

🧬 Clinical Pharmacology 183 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B.

Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

🧬 Mechanism of Action 15 words ▾

Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown.

📦 How Supplied / Storage and Handling 123 words ▾

HOW SUPPLIED CLEOCIN T Topical Solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 30 mL applicator bottle—NDC 0009-3116-01 60 mL applicator bottle—NDC 0009-3116-02 Carton of 60 single-use pledget applicators—NDC 0009-3116-14 CLEOCIN T Topical Gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes: 60 gram tube—NDC 0009-3331-01 30 gram tube—NDC 0009-3331-02 CLEOCIN T Topical Lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle—NDC 0009-3329-01 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Protect from freezing. CLEOCIN T Topical Solution is flammable. Keep away from heat, sparks or open flames.

📦 Storage and Handling 30 words ▾

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. CLEOCIN T Topical Solution is flammable. Keep away from heat, sparks or open flames.

📋 Description 160 words ▾

DESCRIPTION CLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each CLEOCIN T Topical Solution pledget applicator contains approximately 1 mL of topical solution.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water. The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: 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). Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General CLEOCIN T Topical Solution contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

CLEOCIN T should be prescribed with caution in atopic individuals. Drug Interactions Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Pregnancy: Teratogenic Effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of CLEOCIN T. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.

Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition. Clinical Considerations If used during lactation and CLEOCIN T is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established. Geriatric Use Clinical studies for CLEOCIN T did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🍼 Nursing Mothers 135 words ▾

Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of CLEOCIN T. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant's gastrointestinal flora.

Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition. Clinical Considerations If used during lactation and CLEOCIN T is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

🧬 Pharmacokinetics 70 words ▾

Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label Pfizer NDC 0009-3116-01 Cleocin T ® clindamycin phosphate topical solution, USP 1%* Solution for topical use only 30 mL Rx only PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton Pfizer NDC 0009-3116-01 Cleocin T ® clindamycin phosphate topical solution, USP 1%* Solution for topical use only 30 mL Rx only PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - Pledget Packet Pfizer NDC 0009-3116-14 Cleocin T ® clindamycin phosphate topical solution, USP 1%* Pledget for topical use only 1 Pledget Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 MADE IN CHINA Rx only PRINCIPAL DISPLAY PANEL - Pledget Packet

PRINCIPAL DISPLAY PANEL - 60 Pledget Packet Carton NDC 0009-3116-14 Pfizer Cleocin T ® 1%* clindamycin phosphate topical solution, USP Pledget for topical use only 60 Pledgets Rx only PRINCIPAL DISPLAY PANEL - 60 Pledget Packet Carton

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label Pfizer NDC 0009-3329-01 Cleocin T ® clindamycin phosphate topical lotion 1%* For topical use only 60 mL Rx only PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton Pfizer NDC 0009-3329-01 Cleocin T ® clindamycin phosphate topical lotion 1%* For topical use only 60 mL Rx only PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 60 gram Tube Label NDC 0009-3331-01 60 gram Rx only Cleocin T ® clindamycin phosphate topical gel For topical use only 1%* Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. For external use only.

Avoid contact with eyes. See crimp of tube for Expiration Date and Lot Number. DOSAGE AND USE: See accompanying prescribing information. * Each gram contains clindamycin phosphate equivalent to 10 mg (1%) of clindamycin.

Also contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 PRINCIPAL DISPLAY PANEL - 60 gram Tube Label

PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton NDC 0009-3331-01 Pfizer Cleocin T ® 1%* clindamycin phosphate topical gel For topical use only 60 gram Rx only PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton

PRINCIPAL DISPLAY PANEL - 30 gram Tube Label NDC 0009-3331-02 30 gram Rx only Cleocin T ® clindamycin phosphate topical gel For topical use only 1%* Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from freezing. For external use only.

Avoid contact with eyes. See crimp of tube for Expiration Date and Lot Number. DOSAGE AND USE: See accompanying prescribing information. * Each gram contains clindamycin phosphate equivalent to 10 mg (1%) of clindamycin.

Also contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 PRINCIPAL DISPLAY PANEL - 30 gram Tube Label

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton NDC 0009-3331-02 Pfizer Cleocin T ® 1%* clindamycin phosphate topical gel For topical use only 30 gram Rx only PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

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 · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Cleocin T — 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 Cleocin T. 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
$7.2K
Claims incl. refills
49
Beneficiaries
20
Spend / beneficiary
$361.56
Spend / claim
$147.57
💵 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.

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 Cleocin T (this brand).

Top reported reactions

Rash277
Drug Hypersensitivity238
Diarrhoea222
Nausea219
Fatigue207
Pain175
Pruritus172

Age at onset

Neonate11
Infant5
Child14
Adolescent42
Adult355
Elderly132

Reporter sex

3,853 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,167
Life-threatening217
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 343 179
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 No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Pharmacia & Upjohn Company LLC 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.
← 00009-3073-22 · Pharmacia 00009-3169-06 · Pharmacia →
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.