FDA.reportPublic FDA data

sunmark nasal

Product NDC
49348-130
Requested package NDC
49348-130-27
11-digit product format
493480130
Labeler code
49348
Product ID
49348-130_adb918ac-e3e2-4996-9d6c-c8563df7b05f
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY
Route
NASAL
Labeler
Strategic Sourcing Services LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-09-26
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 g/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 packagepackage49348-13049348-130-27DDiscontinued by firm2026-10-05

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-130-27ML - Milliliter49348-130b4648f48-f791-4e5e-9f50-cca2fb6d823012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0RSUNMARK NASAL (OXYMETAZOLINE HCL) SPRAY [MCKESSON]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49348-130-27493480130271 BOTTLE, SPRAY in 1 CARTON (49348-130-27) > 30 mL in 1 BOTTLE, SPRAY2014-09-260000-00-00NoNoCurrent