FDA.reportPublic FDA data

Sunmark Nasal

Product NDC
49348-028
Requested package NDC
49348-028-27
11-digit product format
493480028
Labeler code
49348
Product ID
49348-028_9193775f-9fcd-4991-a383-1b393b4a0b09
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-06-27
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage49348-02849348-028-27DDiscontinued by firm2026-10-15

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
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-028-27Sunmark NasalOriginal1 in 1 CARTONSPRAY17
49348-028-27Sunmark NasalOriginal30 mL in 1 BOTTLE, SPRAYSPRAY307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-028-27ML - Milliliter49348-028a10c7bc4-73ea-40fb-a72a-4a38091ac8c612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MCKESSON]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-028SUNMARK NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [STRATEGIC SOURCING SERVICES LLC]7Legacy NDC, 2 package rows20241013_fb25811d-f18c-4817-8757-1ead53a0b7a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNfb25811d-f18c-4817-8757-1ead53a0b7a97
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDfb25811d-f18c-4817-8757-1ead53a0b7a97
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYfb25811d-f18c-4817-8757-1ead53a0b7a97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-028-27493480028271 BOTTLE, SPRAY in 1 CARTON (49348-028-27) > 30 mL in 1 BOTTLE, SPRAY2003-06-270000-00-00NoNoCurrent