FDA.reportPublic FDA data

Clindagel

Product NDC
16781-462
11-digit product format
167810462
Labeler code
16781
Product ID
16781-462_cb49818a-19bc-4bcc-8696-a8b749fefbe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLINDAMYCIN
Dosage form
GEL
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA050782
Marketing category
NDA
Marketing start
2013-11-25
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindagel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui309332, 351330

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
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
16781-462-06Clindagel7.3 mL in 1 BOTTLEGEL7.39
16781-462-06Clindagel6 in 1 CARTONGEL69
16781-462-07Clindagel1 in 1 CARTONGEL19
16781-462-07Clindagel7.3 mL in 1 BOTTLEGEL7.39
16781-462-40Clindagel1 in 1 CARTONGEL19
16781-462-40Clindagel40 mL in 1 BOTTLEGEL409
16781-462-75Clindagel1 in 1 CARTONGEL19
16781-462-75Clindagel75 mL in 1 BOTTLEGEL759

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16781-462-75ML - Milliliter16781-4627f0d0ae0-873f-4a26-8a65-77a623eff8ad12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCCLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLINDAGEL (CLINDAMYCIN) GEL [ONSET DERMATOLOGICS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16781-462CLINDAGEL (CLINDAMYCIN) GEL [BAUSCH HEALTH US, LLC]8Current NDC, Legacy NDC, 8 package rows20241023_f7b4e985-719a-4547-b624-94612d520991.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351330Clindagel 1 % Once-Daily Topical GelPSNf7b4e985-719a-4547-b624-94612d5209919
309332clindamycin phosphate 1 % Once-Daily Topical GelPSNf7b4e985-719a-4547-b624-94612d5209919
351330Once-Daily clindamycin 0.01 MG/MG Topical Gel [Clindagel]SBDf7b4e985-719a-4547-b624-94612d5209919
309332Once-Daily clindamycin 0.01 MG/MG Topical GelSCDf7b4e985-719a-4547-b624-94612d5209919
351330Clindagel (as clindamycin phosphate) 1 % Topical GelSYf7b4e985-719a-4547-b624-94612d5209919
351330Clindagel 0.01 MG/MG Topical GelSYf7b4e985-719a-4547-b624-94612d5209919
351330Clindagel 1 % Once-Daily Topical GelSYf7b4e985-719a-4547-b624-94612d5209919
309332clindamycin (as clindamycin phosphate) 1 % Once-Daily Topical GelSYf7b4e985-719a-4547-b624-94612d5209919
309332clindamycin 1 % Once-Daily Topical GelSYf7b4e985-719a-4547-b624-94612d5209919
351330Once-Daily Clindagel 0.01 MG/MG Topical GelSYf7b4e985-719a-4547-b624-94612d5209919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16781-462-06167810462066 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLE6 bottle2015-07-010000-00-00YesNoCurrent
16781-462-07167810462071 in 1 CARTONHistorical
16781-462-40167810462401 in 1 CARTONHistorical
16781-462-75167810462751 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLE1 bottle2013-11-250000-00-00NoNoCurrent