Cleocin T - Pharmacia & Upjohn Company LLC

Manufacturer
Pharmacia & Upjohn Company LLC
Effective date
2025-11-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
30
Source
full-release
Hydrated at
2026-05-31 21:46:55

Label at a glance#

ProductCleocin T
Active ingredientCLINDAMYCIN PHOSPHATE
Label structure22 sections

Indications and uses

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

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 applicatio...

Label contents#

Full prescribing information#

      

SPL UNCLASSIFIED SECTION

For External Use

DESCRIPTION

DESCRIPTION SECTION

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:

Chemical Structure
Chemical Structure

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).

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

     

Mechanism of Action

MECHANISM OF ACTION SECTION

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

Pharmacokinetics

PHARMACOKINETICS SECTION

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

MICROBIOLOGY SECTION

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Antimicrobial Activity

SPL UNCLASSIFIED SECTION

Clindamycin is active in vitro against most isolates of Propionibacterium acnes; however, the clinical significance is unknown.

Resistance

SPL UNCLASSIFIED SECTION

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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).

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

     

General

GENERAL PRECAUTIONS SECTION

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

DRUG INTERACTIONS SECTION

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 SECTION

     

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

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

NURSING MOTHERS SECTION

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

SPL UNCLASSIFIED SECTION

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

PEDIATRIC USE SECTION

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

Geriatric Use

GERIATRIC USE SECTION

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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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* (10)

Peeling

61 (11)

# ( – )

11 ( 7)

* of 126 subjects

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.

OVERDOSAGE

OVERDOSAGE SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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.

      

SPL UNCLASSIFIED SECTION

Rx only

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Logo
Logo

LAB-0042-11.0
Revised 11/2025

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 30 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - Pledget Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - Pledget Packet

PRINCIPAL DISPLAY PANEL - 60 Pledget Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Pledget Packet Carton

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 60 gram Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label

PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 60 gram Tube Carton

PRINCIPAL DISPLAY PANEL - 30 gram Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
804975Cleocin T 1 % Topical SolutionPSN30
804978Cleocin T 1 % Twice-Daily Topical GelPSN30
804973Cleocin-T 1 % Topical LotionPSN30
197519clindamycin phosphate 1 % Topical LotionPSN30
309333clindamycin phosphate 1 % Topical SolutionPSN30
2676585clindamycin phosphate 1 % Twice-Daily Topical GelPSN30
804973clindamycin 10 MG/ML Topical Lotion [Cleocin-T]SBD30
804975clindamycin 10 MG/ML Topical Solution [Cleocin-T]SBD30
804978Twice-Daily clindamycin 0.01 MG/MG Topical Gel [Cleocin-T]SBD30
197519clindamycin 10 MG/ML Topical LotionSCD30
309333clindamycin 10 MG/ML Topical SolutionSCD30
2676585Twice-Daily clindamycin 0.01 MG/MG Topical GelSCD30
804975Cleocin T Pledget 1 % Topical SolutionSY30
804978Cleocin-T (as clindamycin phosphate) 1 % Topical GelSY30
804973Cleocin-T (as clindamycin phosphate) 1 % Topical LotionSY30
804975Cleocin-T (as clindamycin phosphate) 1 % Topical SolutionSY30
804978Cleocin-T 0.01 MG/MG Topical GelSY30
804973Cleocin-T 1 % Topical LotionSY30
804975Cleocin-T 1 % Topical SolutionSY30
804978Cleocin-T 1 % Twice-Daily Topical GelSY30
804973Cleocin-T 10 MG/ML Topical LotionSY30
804975Cleocin-T 10 MG/ML Topical SolutionSY30
197519clindamycin (as clindamycin phosphate) 1 % Topical LotionSY30
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSY30
2676585clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical GelSY30
197519clindamycin 1 % Topical LotionSY30
309333clindamycin 1 % Topical SolutionSY30
804978Twice-Daily Cleocin-T 0.01 MG/MG Topical GelSY30

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLINDAMYCIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20210811

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)00300093329010GTIN-14: 00300093329010
GTIN-12: 300093329010
UPC-A: 300093329010
EAN-13: 0300093329010
GTIN storage (14 digits): 00300093329010
cleocin-t-06.jpg
BarcodeDataBar Limited(01)00300093331020GTIN-14: 00300093331020
GTIN-12: 300093331020
UPC-A: 300093331020
EAN-13: 0300093331020
GTIN storage (14 digits): 00300093331020
cleocin-t-10.jpg
BarcodeEAN-130300093116016GTIN-13: 0300093116016
EAN-13: 0300093116016
GTIN-12: 300093116016
UPC-A: 300093116016
GTIN storage (14 digits): 00300093116016
cleocin-t-04.jpg
Data codeData MatrixPAA077378cleocin-t-11.jpg
Data codeData MatrixPAA097519cleocin-t-07.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-3116-01Cleocin T30 mL in 1 BOTTLESOLUTION3030
0009-3116-01Cleocin T1 in 1 CARTONSOLUTION130
0009-3116-02Cleocin T60 mL in 1 BOTTLESOLUTION6030
0009-3116-02Cleocin T1 in 1 CARTONSOLUTION130
0009-3116-14Cleocin T1 mL in 1 PACKETSOLUTION130
0009-3116-14Cleocin T60 in 1 CARTONSOLUTION6030
0009-3329-01Cleocin T60 mL in 1 BOTTLELOTION6030
0009-3329-01Cleocin T1 in 1 CARTONLOTION130
0009-3331-01Cleocin T1 in 1 CARTONGEL130
0009-3331-01Cleocin T60 g in 1 TUBEGEL6030
0009-3331-02Cleocin T30 g in 1 TUBEGEL3030
0009-3331-02Cleocin T1 in 1 CARTONGEL130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3116-01ML - Milliliter0009-31161eb9d45c-b035-4158-88b9-76f48fe60f7912012-07-24
0009-3116-02ML - Milliliter0009-311624f4dfd7-2c75-4f7f-b3eb-0239fd137bb612012-07-24
0009-3116-14EA - Each0009-3116a906d567-2f88-4453-bc5c-6ea023f86daf12012-07-24
0009-3329-01ML - Milliliter0009-3329060b71cd-b513-45e6-8c42-9b270af965c412012-07-24
0009-3331-01GM - Gram0009-3331e0145e85-dee3-40c9-a3a3-0b8b136a2a0612012-07-24
0009-3331-02GM - Gram0009-33319ba379a8-b7b0-4ccc-a138-2635a833b70512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I813
CLINDAMYCINACTIVE MOIETY3U02EL437C13
ALLANTOININACTIVE INGREDIENT344S277G0Z13
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK3113
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S13
GLYCERININACTIVE INGREDIENTPDC6A3C0OX13
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M41630213
ISOSTEARYL ALCOHOLINACTIVE INGREDIENTQ613OCQ44Y13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ13
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V313
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I13
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS9961813
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP13
WATERINACTIVE INGREDIENT059QF0KO0R13

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOSTEARYL ALCOHOLISOSTEARYL ALCOHOLQ613OCQ44YLOTION / TOPICAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOSTEARYL ALCOHOLISOSTEARYL ALCOHOLQ613OCQ44YLOTION / TOPICAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAUROYL SARCOSINATESODIUM LAUROYL SARCOSINATE632GS99618LOTION / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050537-001CLEOCIN TCLINDAMYCIN PHOSPHATEEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982
N050537-002CLEOCINCLINDAMYCIN PHOSPHATEEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SWAB / TOPICALRLD1994-02-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982c2088c7a36db…
2026-10-15 13:18:302026-09N050537-002CLEOCINEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SWAB / TOPICALRLD1994-02-22c2088c7a36db…
2026-09-14 22:38:342026-08N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N050537-002CLEOCINEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SWAB / TOPICALRLD1994-02-2284e616aacf4f…
2026-08-18 06:07:402026-07N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N050537-002CLEOCINEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SWAB / TOPICALRLD1994-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050537-001CLEOCIN TEQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / TOPICALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050537-001CLEOCIN TEQ 1% BASESOLUTION / TOPICALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050537-001CLEOCIN TEQ 1% BASESOLUTION / TOPICALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050537-001CLEOCIN TEQ 1% BASESOLUTION / TOPICALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050537-002CLEOCINEQ 1% BASESWAB / TOPICALRLD1994-02-224b0b4de00fa7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N050537-001AT174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050537-002AT174a2ff9319b5…
2021-03-12 10:30 UTC2021-03N050537-002AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050537-001AT18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050537-002AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050537-001AT1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050537-002AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050537-001AT13f01610625f2…
2019-12-14 00:12 UTC2019-12N050537-002AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N050537-001AT1b00525d2431f…
2019-09-15 20:21 UTC2019-09N050537-002AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050537-001AT1ea99ee380514…
2019-07-19 19:46 UTC2019-07N050537-002AT1ea99ee380514…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050600-001CLEOCIN TCLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050600-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31c2088c7a36db…
2026-09-14 22:38:342026-08N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3184e616aacf4f…
2026-08-18 06:07:402026-07N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-313f01610625f2…
2019-09-15 20:21 UTC2019-09N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050600-001CLEOCIN TEQ 1% BASELOTION / TOPICALABRLD, RS1989-05-313a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N050600-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N050600-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N050600-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050600-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050600-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050600-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050600-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050600-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050600-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050600-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050600-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050600-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050600-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050600-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050600-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050600-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050600-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050600-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050600-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050600-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050600-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050600-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050600-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050600-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050600-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050600-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050600-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050600-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050600-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050600-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050600-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050600-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050600-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050600-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050600-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050600-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050600-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050600-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050600-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050600-001AB13a93d1ddd44b…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050615-001CLEOCIN TCLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050615-001AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07c2088c7a36db…
2026-09-14 22:38:342026-08N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-0784e616aacf4f…
2026-08-18 06:07:402026-07N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-073f01610625f2…
2019-09-15 20:21 UTC2019-09N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALABRLD, RS1987-01-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050615-001CLEOCIN TEQ 1% BASEGEL / TOPICALAB1RLD, RS1987-01-073a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N050615-001AB11c2088c7a36db…
2026-09-14 22:38:342026-08N050615-001AB1184e616aacf4f…
2026-08-18 06:07:402026-07N050615-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050615-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050615-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050615-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050615-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050615-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050615-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050615-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050615-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050615-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050615-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050615-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050615-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050615-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050615-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050615-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050615-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050615-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050615-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050615-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050615-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050615-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050615-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050615-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050615-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050615-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050615-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050615-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050615-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050615-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050615-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050615-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050615-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050615-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050615-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05N050615-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01N050615-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050615-001AB113a93d1ddd44b…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cleocin TCLINDAMYCIN PHOSPHATEPharmacia & Upjohn Company LLC4a3901a4-194f-4a15-9c85-3d0982afcf312025-11-24Warnings, Adverse reactionsExact identifier
ndc (package): 0009-3329-01
ndc (package): 0009-3116-14
ndc (package): 0009-3331-01
ndc (package): 0009-3116-02
ndc (package): 0009-3331-02
ndc (package): 0009-3116-01
ndc (product): 0009-3331
ndc (product): 0009-3329
ndc (product): 0009-3116
ndc11 (package): 00009333101
ndc11 (package): 00009311602
ndc11 (package): 00009332901
ndc11 (package): 00009311601
ndc11 (package): 00009311614
ndc11 (package): 00009333102
spl id: 469e01f2-6431-4cee-8e1d-073fe187f87d
spl set id: 4a3901a4-194f-4a15-9c85-3d0982afcf31

Reported adverse events (FAERS/openFDA)#

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