Benzaclin

Product NDC
0187-5190
11-digit product format
001875190
Labeler code
0187
Product ID
0187-5190_4d429947-c5e7-4bb1-8881-6fd591b637b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin phosphate and benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Bausch Health US LLC
Application
NDA050756
Marketing category
NDA
Marketing start
2000-12-21
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength
50 mg/g; mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5190-25GM - Gram0187-519052bbb906-f8a4-46aa-a09f-27db2945726e12013-07-02
0187-5190-35GM - Gram0187-5190c1af9007-bd34-47db-b427-b2e389488a4e12013-07-02
0187-5190-50GM - Gram0187-5190f0792373-610c-498e-8fe6-cc0d695c447912013-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5190BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [BAUSCH HEALTH US LLC]15Legacy NDC20230204_4c6b2aca-d940-42af-a068-418f015d277a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5190-25001875190251 JAR in 1 CARTON (0187-5190-25) > 25 g in 1 JAR1 jar2000-12-210000-00-00NoNoCurrent
0187-5190-35001875190351 BOTTLE, PUMP in 1 CARTON (0187-5190-35) > 35 g in 1 BOTTLE, PUMP2000-12-210000-00-00NoNoCurrent
0187-5190-50001875190501 BOTTLE, PUMP in 1 CARTON (0187-5190-50) > 50 g in 1 BOTTLE, PUMP2000-12-210000-00-00NoNoCurrent