Home NDC 67510-1670-1 Triple Antibiotic Plus Pain Relief
Product NDC 67510-1670
Requested package NDC 67510-1670-1
11-digit product format 675101670
Labeler code 67510
Product ID 67510-1670_9ee421b7-bbd7-6d33-e053-2a95a90a2b47
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form OINTMENT
Route TOPICAL
Labeler Kareway Product, Inc.
Application part333B
Marketing category OTC MONOGRAPH FINAL
Marketing start 2017-07-26
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength 4 mg/g; mg/g; [iU]/g; [iU]/g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67510-1670 67510-1670-1 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-1670-1 67510167001 1 TUBE in 1 CARTON (67510-1670-1) > 28.3 g in 1 TUBE 1 tube 2017-07-26 0000-00-00 No No Current