Bacitraycin MAX Pain Relief

Product NDC
52412-725
Requested package NDC
52412-725-01
11-digit product format
524120725
Labeler code
52412
Product ID
52412-725_db747368-d45f-64e3-e053-2995a90a1fb8
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Pramoxine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Randob Labs Ltd.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-30
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; mg/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-725BACITRAYCIN MAX PAIN RELIEF (BACITRACIN ZINC PRAMOXINE HCL) OINTMENT [RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH]3Legacy NDC20250101_db747126-77d2-2e1d-e053-2a95a90a2d30.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-725-01524120725011 TUBE in 1 CARTON (52412-725-01) > 28 g in 1 TUBE1 tube2022-03-300000-00-00NoNoCurrent