Benzocaine and Triclosan

Product NDC
56104-005
Requested package NDC
56104-005-03
11-digit product format
561040005
Labeler code
56104
Product ID
56104-005_6afc2947-ad77-4493-9876-5f5301f728b0
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
BENZOCAINE; TRICLOSAN
Active strength
17 g/85g; g/85g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage56104-00556104-005-03IInactivated by FDA2026-10-20

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 · 19 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56104-005-032021-07-23C16284748780-1c7ccaba7-279c-fd44-e053-dadaa90aa01bFirst Aid Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-005-03Benzocaine and Triclosan85 g in 1 CANISTERAEROSOL, SPRAY852

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-005BENZOCAINE AND TRICLOSAN (FIRST AID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]2Legacy NDC, 1 package rows20160106_be991a82-15fb-4d95-b61c-7ed45eda1b20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359261benzocaine 20 % / triclosan 0.13 % Topical SprayPSNbe991a82-15fb-4d95-b61c-7ed45eda1b202
359261benzocaine 200 MG/ML / triclosan 1.3 MG/ML Topical SpraySCDbe991a82-15fb-4d95-b61c-7ed45eda1b202
359261benzocaine 20 % / triclosan 0.13 % Topical SpraySYbe991a82-15fb-4d95-b61c-7ed45eda1b202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56104-005-035610400050385 g in 1 CANISTER (56104-005-03) 85 g2013-01-010000-00-00NoNoCurrent