Australian Gold

Product NDC
58443-0327
11-digit product format
584430327
Labeler code
58443
Product ID
58443-0327_a575bf5f-e3ce-1ff5-e053-2995a90a5cb3
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-11-16
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0327-42023-01-30C16284748780-1f386c649-e897-0266-e053-dadaa90a7c1aAustralian Gold Lidocaine ALOE GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0327-4Australian GoldAloe Gel with Lidocaine237 mL in 1 BOTTLEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0327AUSTRALIAN GOLD ALOE GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES, INC.]1Legacy NDC, 1 package rows20200513_a575bf5f-e3cd-1ff5-e053-2995a90a5cb3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0327-458443032704237 mL in 1 BOTTLE (58443-0327-4) 237 ml2015-11-160000-00-00NoNoCurrent