FDA.reportPublic FDA data

CVS Health Triple Antibiotic with Pain Relief

Product NDC
69842-161
11-digit product format
698420161
Labeler code
69842
Product ID
69842-161_5cc951e4-45bd-4c40-9d78-95f8233e7002
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate and Pramoxine HCL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CVS Health
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-04-28
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; [USP'U]/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69842-161DDiscontinued by firm2026-10-05
excluded packagepackage69842-16169842-161-10DDiscontinued by firm2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct69842-161DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69842-16169842-161-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-161CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE AND PRAMOXINE HCL) OINTMENT [CVS HEALTH]3Legacy NDC20241113_4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-161-106984201611024 PACKET in 1 CARTON (69842-161-10) > .9 g in 1 PACKET24 packet2017-04-280000-00-00NoNoCurrent