FDA.reportPublic FDA data

Benzoin

Product NDC
46414-8888
Requested package NDC
46414-8888-2
11-digit product format
464148888
Labeler code
46414
Product ID
46414-8888_a293bdae-e65f-4a0c-afe7-bfaf37b2cff8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoin
Dosage form
SWAB
Route
TOPICAL
Labeler
James Alexander Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1976-10-25
Marketing end
2025-02-28
Substance
BENZOIN, (+/-)-; ALOE; TOLU BALSAM; LIQUIDAMBAR STYRACIFLUA RESIN
Active strength
1 g/.6mL; g/.6mL; g/.6mL; g/.6mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage46414-888846414-8888-2DDiscontinued 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 · 6 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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AloeACTIVE INGREDIENTV5VD430YW9BENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
BenzoinACTIVE INGREDIENTL7J6A1NE81BENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
LIQUIDAMBAR STYRACIFLUA RESINACTIVE INGREDIENTP41GWD11CXBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
TOLU BALSAMACTIVE INGREDIENTTD2LE91MBEBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
ALOE VERA LEAFACTIVE MOIETYZY81Z83H0XBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
BALSAM PERUACTIVE MOIETY8P5F881OCYBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
BenzoinACTIVE MOIETYL7J6A1NE81BENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
LIQUIDAMBAR STYRACIFLUA RESINACTIVE MOIETYP41GWD11CXBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4
AlcoholINACTIVE INGREDIENT3K9958V90MBENZOIN SWAB [JAMES ALEXANDER CORPORATION]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46414-8888-24641488880260 mL in 1 BOX (46414-8888-2) 60 ml1976-10-252025-02-28NoNoCurrent