FDA.reportPublic FDA data

Zilactin-B

Product NDC
50486-550
Requested package NDC
50486-550-32
11-digit product format
504860550
Labeler code
50486
Product ID
50486-550_d17abbc0-8870-6c82-e053-2995a90a5940
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine
Dosage form
GEL
Route
TOPICAL
Labeler
Blairex Laboratories, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-06-29
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
0 g/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 packagepackage50486-55050486-550-32DDiscontinued by firm2026-10-12

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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50486-550-32GM - Gram50486-550e1b1c4b0-fb05-4586-b87a-85c0e65659ec12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW5ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
benzocaineACTIVE MOIETYU3RSY48JW5ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
boric acidINACTIVE INGREDIENTR57ZHV85D4ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
hydroxypropyl cellulose (type M)INACTIVE INGREDIENTU3JF91U133ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
peppermint oilINACTIVE INGREDIENTAV092KU4JHZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
salicylic acidINACTIVE INGREDIENTO414PZ4LPZZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
tannic acidINACTIVE INGREDIENT28F9E0DJY6ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50486-550ZILACTIN-B (BENZOCAINE) GEL [BLAIREX LABORATORIES, INC.]6Legacy NDC20241115_34ce5d91-35ff-4f2c-9d6b-ac389895b6b2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50486-550-32504860550321 TUBE in 1 CARTON (50486-550-32) > 7 g in 1 TUBE1 tube2005-06-290000-00-00NoNoCurrent