FDA.reportPublic FDA data

Sound Body Nasal

Product NDC
50594-017
Requested package NDC
50594-017-10
11-digit product format
505940017
Labeler code
50594
Product ID
50594-017_67814c0b-c95f-44b0-81c8-31215405f82b
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Big Lots Stores, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-05-03
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-01750594-017-10DDiscontinued by firm2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-017SOUND BODY NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BIG LOTS STORES, INC.]6Legacy NDC20241027_c7172a5a-fea4-47a3-b7d3-81479477195e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50594-017-10505940017101 BOTTLE, SPRAY in 1 CARTON (50594-017-10) > 30 mL in 1 BOTTLE, SPRAY2016-05-030000-00-00NoNoCurrent