FDA.reportPublic FDA data

Insect Sting Relief

Product NDC
50814-040
Requested package NDC
50814-040-01
11-digit product format
508140040
Labeler code
50814
Product ID
50814-040_826d0136-d766-7a56-e053-2991aa0a4420
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE, ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
GFA Production (Xiamen) Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-11-11
Marketing end
0000-00-00
Substance
BENZOCAINE; ALCOHOL
Active strength
60 mg/mL; mg/mL
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 packagepackage50814-04050814-040-01DDiscontinued by firm2026-09-14

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 · 3 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 packagepackage50814-04050814-040-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50814-04050814-040-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50814-04050814-040-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-040INSECT STING RELIEF (BENZOCAINE, ALCOHOL) CLOTH [GFA PRODUCTION (XIAMEN) CO., LTD.]5Legacy NDC20250502_12fd8e64-6a11-4a66-be0b-232dfce33e03.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50814-040-0150814004001100 PACKAGE in 1 BOX (50814-040-01) > 1 PACKAGE in 1 PACKAGE > .15 mL in 1 PACKAGE100 package2018-11-110000-00-00NoNoCurrent