Antirobe Aquadrops

Manufacturer
Zoetis Inc.
Effective date
2023-03-31
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:42:00

Label at a glance#

ProductAntirobe Aquadrops
Active ingredientCLINDAMYCIN HYDROCHLORIDE
Label structure17 sections

Dosage and administration

Infected Wounds, Abscesses, and Dental Infections  Oral: 2.5-15.0 mg/lb body weight every 12 hours. Duration: Treatment with ANTIROBE products may be continued up to a maximum of 28 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three or four days if no response to therapy is seen. Dosage Schedule: Capsules ANTIROBE 25 mg, administer 1-6 capsules every 12 h...

Storage and handling

Store at controlled room temperature 20° to 25° C (68° to 77° F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Antirobe Aquadrops® brand of clindamycin hydrochloride oral solution

Caution

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

DESCRIPTION SECTION

ANTIROBE Capsules and ANTIROBE AQUADROPS Liquid contain clindamycin hydrochloride which is the hydrated salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced antibiotic produced by Streptomyces lincolnensis var. lincolnensis.

ANTIROBE Capsules (For Use in Dogs Only):

25 mg Capsule, each yellow and white capsule contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.

75 mg Capsule, each green capsule contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.

150 mg Capsule, each light blue and green capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

ANTIROBE AQUADROPS Liquid (For Use in Dogs and Cats) is a palatable formulation intended for oral administration. Each mL of ANTIROBE AQUADROPS Liquid contains clindamycin hydrochloride equivalent to 25 mg clindamycin; and ethyl alcohol, 7.4%.

ACTIONS

SPL UNCLASSIFIED SECTION

Site and Mode of Action

MECHANISM OF ACTION SECTION

  Clindamycin is an inhibitor of protein synthesis in the bacterial cell. The site of binding appears to be in the 5OS sub-unit of the ribosome. Binding occurs to the soluble RNA fraction of certain ribosomes, thereby inhibiting the binding of amino acids to those ribosomes. Clindamycin differs from cell wall inhibitors in that it causes irreversible modification of the protein-synthesizing subcellular elements at the ribosomal level.

MICROBIOLOGY

MICROBIOLOGY SECTION

 Clindamycin is a lincosaminide antimicrobial agent with activity against a wide variety of aerobic and anaerobic bacterial pathogens. Clindamycin is a bacteriostatic compound that inhibits bacterial protein synthesis by binding to the 5OS ribosomal sub-unit. The minimum inhibitory concentrations (MICs) of Gram-positive and obligate anaerobic pathogens isolated from dogs and cats in the United States are presented in Table 1 and Table 2. Bacteria were isolated in 1998-1999. All MICs were performed in accordance with the National Committee for Clinical Laboratory Standards (NCCLS).

Table 1. Clindamycin MIC Values (μg/mL) from Diagnostic Laboratory Survey Data Evaluating Canine Pathogens in the U.S. during 1998-99*
Organism Number of Isolates MIC50 MIC85 MIC90 Range
 Soft Tissue/Wound†      
   Staphylococcus aureus  17 0.5 0.5 ≥4.0 0.25-≥4.0
   Staphylococcus intermedius  28 0.25 0.5 ≥4.0 0.125-≥4.0
   Staphylococcus spp. 18 0.5 0.5 ≥4.0 0.25-≥4.0
   Beta-hemolytic streptococci 46 0.5 0.5 ≥4.0 0.25-≥4.0
   Streptococcus spp. 11 0.5 ≥4.0 ≥4.0 0.25-≥4.0
 Osteomyelitis/Bone‡      
   Staphylococcus aureus  20 0.5 0.5 0.5 0.5§
   Staphylococcus intermedius  15 0.5 ≥4.0 ≥4.0 0.25-≥4.0
   Staphylococcus spp. 18 0.5 ≥4.0 ≥4.0 0.25-≥4.0
   Beta-hemolytic streptococci 21 0.5 2.0 2.0 0.25-≥4.0
   Streptococcus spp. 21 ≥4.0 ≥4.0 ≥4.0 0.25-≥4.0
 Dermal/Skin      
   Staphylococcus aureus  25 0.5 ≥4.0 ≥4.0 0.25-≥4.0
   Staphylococcus intermedius  48 0.5 ≥4.0 ≥4.0 0.125-≥4.0
   Staphylococcus spp. 32 0.5 ≥4.0 ≥4.0 0.25-≥4.0
   Beta-hemolytic streptococci 17 0.5 0.5 0.5 0.25-0.5

* The correlation between the in vitro susceptibility data and clinical response has not been determined.

† Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass

‡ Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon

§ No range, all isolates yielded the same value

Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip

Table 2. Clindamycin MIC Values (μg/mL) from Diagnostic Laboratory Survey Data Evaluating Feline Pathogens from Wound and Abscess Samples in the U.S. during 1998*
Organism Number of Isolates MIC50 MIC90 Range
 Bacteroides/Prevotella 30 0.06 4.0 ≤0.015-4.0
 Fusobacterium spp. 17 0.25 0.25 ≤0.015-0.5
 Peptostreptococcus spp. 18 0.13 0.5 ≤0.015-8.0
 Porphyromonas spp. 13 0.06 0.25 ≤0.015-8.0

* The correlation between the in vitro susceptibility data and clinical response has not been determined.

PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Absorption

SPL UNCLASSIFIED SECTION

 Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastrointestinal tract.

Dog Serum Levels

SPL UNCLASSIFIED SECTION

 Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 2.5 mg/lb of clindamycin hydrochloride every 12 hours. This same study revealed that average peak serum concentrations of clindamycin occur 1 hour and 15 minutes after oral dosing. The elimination half-life for clindamycin in dog serum was approximately 5 hours. There was no bioactivity accumulation after a regimen of multiple oral doses in healthy dogs.

 Clindamycin Serum Concentrations 2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral Dose of Antirobe Capsules to Dogs
 Figure 1Figure 1

Cat Serum Levels

SPL UNCLASSIFIED SECTION

  Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 5 mg/lb of clindamycin hydrochloride liquid every 24 hours. The average peak serum concentration of clindamycin occurs approximately 1 hour after oral dosing. The elimination half-life of clindamycin in feline serum is approximately 7.5 hours. In healthy cats, minimal accumulation occurs after multiple oral doses of clindamycin hydrochloride, and steady-state should be achieved by the third dose.

 Clindamycin Serum Concentrations 5 mg/lb (11 mg/kg) After Single Oral Dose of Antirobe Aquadrops to Cats
 Figure 2Figure 2

METABOLISM AND EXCRETION

SPL UNCLASSIFIED SECTION

Extensive studies of the metabolism and excretion of clindamycin hydrochloride administered orally in animals and humans have shown that unchanged drug and bioactive and bioinactive metabolites are excreted in urine and feces. Almost all of the bioactivity detected in serum after ANTIROBE product administration is due to the parent molecule (clindamycin). Urine bioactivity, however, reflects a mixture of clindamycin and active metabolites, especially N-demethyl clindamycin and clindamycin sulfoxide.

ANIMAL SAFETY SUMMARY

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION

Rat and Dog Data

SPL UNCLASSIFIED SECTION

 One year oral toxicity studies in rats and dogs at doses of 30, 100 and 300 mg/kg/day (13.6, 45.5 and 136.4 mg/lb/day) have shown clindamycin hydrochloride capsules to be well tolerated. Differences did not occur in the parameters evaluated to assess toxicity when comparing groups of treated animals with contemporary controls. Rats administered clindamycin hydrochloride at 600 mg/kg/day (272.7 mg/lb/day) for six months tolerated the drug well; however, dogs orally dosed at 600 mg/kg/day (272.7 mg/lb/day) vomited, had anorexia, and subsequently lost weight. At necropsy these dogs had erosive gastritis and focal areas of necrosis of the mucosa of the gallbladder.

Safety in gestating bitches or breeding males has not been established.

Cat Data

SPL UNCLASSIFIED SECTION

 The recommended daily therapeutic dose range for clindamycin hydrochloride (ANTIROBE AQUADROPS oral solution) is 11 to 33 mg/kg/day (5 to 15 mg/lb/day) depending on the severity of the condition. Clindamycin hydrochloride (ANTIROBE AQUADROPS oral soluation) was tolerated with little evidence of toxicity in domestic shorthair cats when administered orally at 10× the minimum recommended therapeutic daily dose (11 mg/kg; 5 mg/lb) for 15 days, and at doses up to 5× the minimum recommended therapeutic dose for 42 days. Gastrointestinal tract upset (soft feces to diarrhea) occurred in control and treated cats with emesis occurring at doses 3× or greater than the minimum recommended therapeutic dose (11 mg/kg/day; 5 mg/lb/day). Lymphocytic inflammation of the gallbladder was noted in a greater number of treated cats at the 110 mg/kg/day (50 mg/lb/day) dose level than for control cats. No other effects were noted. Safety in gestating queens or breeding male cats has not been established.

INDICATIONS

INDICATIONS & USAGE SECTION

ANTIROBE (brand of clindamycin hydrochloride) Capsules (for use in dogs only) and AQUADROPS oral solution (for use in dogs and cats) are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.

Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp. Deep wounds and abscesses due to Clostridium perfringens and Bacteroides fragilis.

Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

ANTIROBE Capsules and ANTIROBE AQUADROPS oral solution are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Because of potential adverse gastrointestinal effects, do not administer to rabbits, hamsters, guinea pigs, horses, chinchillas or ruminating animals.

WARNINGS

WARNINGS SECTION

Keep out of reach of children. Not for human use.

PRECAUTIONS

PRECAUTIONS SECTION

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

The use of ANTIROBE occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of ANTIROBE should be avoided in those species sensitive to the gastrointestinal effects of clindamycin (see CONTRAINDICATIONS). Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.

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

Safety in gestating bitches and queens or breeding male dogs and cats has not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Side effects occasionally observed in either clinical trials or during clinical use were vomiting and diarrhea.

To report adverse reactions or a suspected adverse reaction call 1-888-963-8471.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dogs

SPL UNCLASSIFIED SECTION

Infected Wounds, Abscesses, and Dental Infections 

Oral: 2.5-15.0 mg/lb body weight every 12 hours.

Duration: Treatment with ANTIROBE products may be continued up to a maximum of 28 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three or four days if no response to therapy is seen.

Dosage Schedule:

Capsules

ANTIROBE 25 mg, administer 1-6 capsules every 12 hours for each 10 pounds of body weight.

ANTIROBE 75 mg, administer 1-6 capsules every 12 hours for each 30 pounds of body weight.

ANTIROBE 150 mg, administer 1-6 capsules every 12 hours for each 60 pounds of body weight.

Oral Solution

ANTIROBE AQUADROPS, administer 1-6 mL/10 lbs body weight every 12 hours.

Dogs

SPL UNCLASSIFIED SECTION

Osteomyelitis

Oral: 5.0-15.0 mg/lb body weight every 12 hours

Duration: Treatment with ANTIROBE is recommended for a minimum of 28 days. Treatment should not be continued for longer than 28 days if no response to therapy is seen.

Dosage Schedule:

Capsules

ANTIROBE 25 mg, administer 2-6 capsules every 12 hours for each 10 pounds of body weight.

ANTIROBE 75 mg, administer 2-6 capsules every 12 hours for each 30 pounds of body weight.

ANTIROBE 150 mg, administer 2-6 capsules every 12 hours for each 60 pounds of body weight.

Oral Solution

ANTIROBE AQUADROPS, administer 2-6 mL/ 10 lbs body weight every 12 hours.

Cats

SPL UNCLASSIFIED SECTION

Infected Wounds, Abscesses, and Dental Infections

5.0 - 15.0 mg/lb body weight once every 24 hours depending on the severity of the condition.

Duration: Treatment with ANTIROBE AQUADROPS oral solution may be continued up to a maximum of 14 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three to four days if no clinical response to therapy is seen.

Dosage Schedule:

ANTIROBE AQUADROPS, to provide 5.0 mg/lb, administer 1 mL/5 lbs body weight once every 24 hours; to provide 15.0 mg/lb, administer 3 mL/5 lbs body weight once every 24 hours.

HOW SUPPLIED

HOW SUPPLIED SECTION

ANTIROBE AQUADROPS oral solution is available as 20 mL filled in 30 mL bottles (25 mg/mL) supplied in packers containing 12 cartoned bottles with direction labels and calibrated dosing droppers.

Approved by FDA under NADA # 135-940

For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Zoetis Inc. at 1-888-963-8471. For additional information aboutadverse drug experience reporting for animaldrugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

Storage

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20° to 25° C (68° to 77° F).

SPL UNCLASSIFIED SECTION

ANTIROBE AQUADROPS
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

ANTIROBE Capsules
Manufactured for:
Zoetis Inc. by Patheon Inc.
Whitby, Canada

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Product of China

Revised: September 2022

40040699

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelCarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1371353ANTIROBE 25 MG/mL Oral SolutionPSN6
900424clindamycin HCl 25 MG/mL Oral SolutionPSN6
1371353clindamycin 25 MG/ML Oral Solution [ANTIROBE]SBD6
900424clindamycin 25 MG/ML Oral SolutionSCD6
1371353ANTIROBE (clindamycin 25 MG/mL (as clindamycin hydrochloride)) Oral SolutionSY6
1371353ANTIROBE 25 MG/mL Oral SolutionSY6
900424clindamycin (as clindamycin HCl) 25 MG/mL Oral SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
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d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
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028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
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8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54771-3179-1Antirobe Aquadrops1 in 1 CARTONLIQUID16
54771-3179-1Antirobe Aquadrops20 mL in 1 BOTTLELIQUID206
54771-3179-2Antirobe Aquadrops12 in 1 CASELIQUID126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54771-3179ANTIROBE AQUADROPS (CLINDAMYCIN HYDROCHLORIDE) LIQUID [ZOETIS INC.]63 package rows20230426_a2224602-6f04-4b83-968a-8c193230998f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
clindamycin hydrochlorideACTIVE INGREDIENTT20OQ1YN1W1
clindamycinACTIVE MOIETY3U02EL437C1
alcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54771-317954771-3179-1, 54771-3179-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLINDAMYCIN HYDROCHLORIDET20OQ1YN1WACTIM
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.fa084aad-07fa-44d2-8d01-d32f40acd2f32026-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.7f7fc73a-86e1-4d3e-8c83-1c74621e4af42026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEHAWAII REPACK, INC.c6703df0-b41d-439f-8e0d-d30b3039b3f82026-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacy1dd9e6b0-bcf4-5bf4-e063-6394a90a10c22026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsd53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef52026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.fadc321a-2291-4268-936f-0743fdddbe7f2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEMajor Pharmaceuticalsf9e6ed50-ad03-4a9e-8760-8733e04a058c2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.1dbd8448-c1e5-46df-8060-50ef823804452026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack47f76d99-2024-4531-a527-66c80deeeb372026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1f1b9230-b8ef-b0e4-e063-6394a90afc472026-06-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEUnit Dose Solutions, Inc.535e7e17-d020-4aa6-e063-6294a90ae1142026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDEGolden State Medical Supply, Inc.a69260bb-31b5-4f77-e053-2995a90a37e12026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepacke4d91d51-b92e-4d3e-8379-f9463f4505372026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEProficient Rx LPd1aa1e91-4ac8-40d1-9fc4-963e1c9c32782026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDECoupler LLC509a9bc3-0901-0874-e063-6294a90a88162026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLINDAMYCIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.