Galentic Triple Antibiotic Plus Pain Relief

Product NDC
50382-052
11-digit product format
503820052
Labeler code
50382
Product ID
50382-052_98b72992-858d-22f6-e053-2a95a90a950f
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-02-28
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; mg/g; [USP'U]/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50382-052-135038200521328 g in 1 TUBE (50382-052-13) 28 g2019-12-150000-00-00NoNoCurrent