Clindamycin Phosphate 10 mg/mL Lotion — NDC 51672-1400-4 (Billing 51672-1400-04)
This is a package of Clindamycin Phosphate 10 mg/mL Lotion from Sun Pharmaceutical Industries, Inc., marketed since Jun 2021 and currently FDA-listed; retail pharmacies pay about $0.2448 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 51672-1400-4 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 51672 labeler · 1400 product · 4 package
- Package marketed since
- Jun 28, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5167214004 5
- Medicaid fills, this package
- 82,256 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
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 011752
- GCN: 31770
- GPI-14 (Medi-Span): 90051010104105
- HICL (First Databank): 004045
- AHFS class code: 08:12.28.20
- RxCUI (RxNorm): 197519
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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?
Patient education
Supplement & herbal interactions
Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.245 | $14.69 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.4977 | $29.86 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.6184 | $37.10 / 60 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 51672-1400-04 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | 2021-06-28 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| clindamycin phosphate 10 mg/mL 00168-0203-60 | E. | 1 bottle | $0.245 | AB | Availability likely | — |
| Clindamycin Phosphate 10 ug/mL 16714-0246-01 | NORTHSTAR | 1 bottle | $0.245 | AB | Availability likely | — |
| Clindamycin Phosphate 10 ug/mL 21922-0036-01 | Encube | 1 bottle | $0.245 | AB | Availability likely | — |
| Clindamycin Phosphate 10 mg/mL 45802-0128-01 | Padagis | 60 ml | $0.245 | AB | Availability likely | — |
| Clindamycin Phosphate 10 mg/mLthis 51672-1400-04 | Sun | 1 bottle | $0.245 | AB | Availability likely | — |
| clindamycin phosphate 10 mg/mL 59762-3744-01 | Mylan | 1 bottle | $0.245 | AB | Availability likely | — |
| Cleocin T 10 mg/mL 00009-3329-01 | Pharmacia | 1 bottle | $0.465 | AB | FDA listed | +90% |
| Clindamycin Phosphate 10 mg/mL 68682-0462-75 | Oceanside | 1 bottle | $5.280 | AB2 | FDA listed | +2057% |
| Clindamycin Phosphate 10 mg/mL 63629-8632-01 | Bryant | 60 ml | — | AB | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 63629-9459-01 | Bryant | 60 ml | — | AB | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 71335-2953-01 | Bryant | 60 ml | — | AB | FDA listed | — |
| Clindamycin Phosphate 10 mg/mL 72162-1395-06 | Bryant | 60 ml | — | AB | FDA listed | — |
| clindamycin phosphate 10 mg/mL 72162-2147-06 | Bryant | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 51672
- Betamethasone dipropionate .5 mg/g Spray NDC 51672-1390-4
- OXCARBAZEPINE 60 mg/mL Suspension NDC 51672-1393-1
- Tretinoin .5 mg/g Cream NDC 51672-1394-0
- Tretinoin 1 mg/g Cream NDC 51672-1395-0
- Desoximetasone 2.5 mg/mL Spray NDC 51672-1396-3
- Clindamycin Phosphate 10 mg/g Gel NDC 51672-1399-2
- Calcipotriene and Betamethasone Dipropionate 50 ug/g; 50 mg/g Suspension NDC 51672-1402-4
- Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 50 mg/g Gel NDC 51672-1403-4
- Oxymetazoline Hydrochloride 10 mg/g Cream NDC 51672-1405-2
- Docosanol 100 mg/g Cream NDC 51672-1406-2
- Tretinoin .25 mg/g Cream NDC 51672-1407-0
- Ibuprofen 100 mg/5mL Suspension NDC 51672-1409-8
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin phosphate topical lotion is 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 ▾
DOSAGE AND ADMINISTRATION Apply a thin film of clindamycin phosphate topical lotion twice daily to affected area. Shake well immediately before using. Keep all liquid dosage forms in containers tightly closed.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin phosphate topical lotion is 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 ▾
WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis.
Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium 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 ▾
ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin phosphate 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 (%) Burning 62 (11) 15 (10) 17 (11) Itching 36 (7) 15 (10) 17 (11) Burning/Itching 60 (11) not recorded ( – ) ( – ) 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 ▾
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 ▾
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 ▾
Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies for clindamycin phosphate 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 ▾
OVERDOSAGE Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS ).
🧬 Clinical Pharmacology ▾
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 to 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 ▾
Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin Phosphate Topical Lotion, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size: 60 mL plastic squeeze bottle – NDC 51672-1400-4 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.
📋 Description ▾
DESCRIPTION Clindamycin Phosphate Topical Lotion, 1% contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. 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 lotion contains cetostearyl alcohol (2.5%), glycerin, glyceryl stearate SE (with potassium monostearate), isostearyl alcohol (2.5%), methylparaben (0.3%), purified water, sodium lauroyl sarcosinate and stearic acid.
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 ▾
PRECAUTIONS General Clindamycin phosphate topical lotion 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 clindamycin phosphate topical lotion. 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 clindamycin phosphate topical lotion 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 clindamycin phosphate 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 ▾
Nursing Mothers It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate topical lotion. 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 clindamycin phosphate topical lotion is applied to the chest, care should be taken to avoid accidental ingestion by the infant.
🧬 Pharmacokinetics ▾
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 to 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 ▾
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton 60 mL NDC 51672-1400-4 Clindamycin Phosphate Topical Lotion 1% FOR TOPICAL USE ONLY Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton