FDA.reportPublic FDA data

Fonow

Product NDC
52454-001
Requested package NDC
52454-001-02
11-digit product format
524540001
Labeler code
52454
Product ID
52454-001_c0eef8fa-7a70-7653-e053-2a95a90a99a0
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin, Neomycin, Polymyxin B, Lidocaine HCL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zhejiang Fonow Medicine Co., Ltd.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE
Active strength
500 [iU]/g; mg/g; [iU]/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52454-00152454-001-02DDiscontinued by firm2026-10-15

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 packagepackage52454-00152454-001-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52454-00152454-001-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52454-001-012023-06-2974057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022023-06-2974057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-032023-06-2974057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012023-01-3074057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022023-01-3074057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-032023-01-3074057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012020-02-2874057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022020-02-2874057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012020-01-3174057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022020-01-3174057ff8-d4c9-4e7d-84f9-c34b2d793e5f

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52454-001FONOW (BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE HCL) OINTMENT [ZHEJIANG FONOW MEDICINE CO., LTD.]11Legacy NDC20250224_74057ff8-d4c9-4e7d-84f9-c34b2d793e5f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52454-001-02524540001021 TUBE in 1 BOX (52454-001-02) > 15 g in 1 TUBE1 tube2018-01-010000-00-00NoNoCurrent