FDA.reportPublic FDA data

SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol

Product NDC
50580-368
11-digit product format
505800368
Labeler code
50580
Product ID
50580-368_33fe2091-3984-713a-e063-6394a90ad28c
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
50 mg/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE50 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1001081Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33fe0e49-3de5-8afd-e063-6294a90a0ad5Available on FDA.report

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-368-01SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol1 in 1 CARTONSPRAY11
50580-368-01SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol30 mL in 1 BOTTLESPRAY301

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 143 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoloMax Cold CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBENARD INDUSTRIES INC520aee75-8b9a-4dcc-8970-75e122640e912024-10-31WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionsb6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe2024-10-31WarningsExact identifier
application number: M012
CareOne Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmerican Sales Company819d5c82-0240-4013-9904-c335bd65d03e2024-10-30WarningsExact identifier
application number: M012
Signature Care Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway9a0ad5d5-8fd9-468d-be2c-87c14d08b9342024-10-30WarningsExact identifier
application number: M012
Good Sense Severe NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL. Perrigo Companyf2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd22024-10-30WarningsExact identifier
application number: M012
dg health cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLDolgencorp, LLC81f3ac36-9bae-4f42-92a0-8a2e4bbd09842024-10-30WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation9a71e8eb-4195-4694-bf3e-44f691ff2cef2024-10-30WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLH E Bfe4a95d2-6fb3-43fe-baec-6f22d19653232024-10-30WarningsExact identifier
application number: M012
NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger Company2c9ef0d7-3d5b-494a-8f06-9dd42110d78a2024-10-30WarningsExact identifier
application number: M012
Severe NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacyd40d6fd1-3f84-40ae-ab7e-04569eb416172024-10-30WarningsExact identifier
application number: M012
equaline nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI4e0c6ad6-81ef-4b0e-b2eb-44256faf73582024-10-30WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fbe2c0-7749-4c8a-e063-6394a90a7c6e2024-10-30WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC130e68d1-9048-49c1-beee-490eecaed2d92024-10-30WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company02f3e739-3153-412f-b2cd-6f01dcd5875b2024-10-30WarningsExact identifier
application number: M012
HealthWise Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcare25a19d3e-37b3-50d5-e063-6394a90a97d12024-10-29WarningsExact identifier
application number: M012
Antigrip FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23a03-6110-f595-e063-6394a90a70fe2024-10-29WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC25a23e5e-302a-7b7f-e063-6294a90a04632024-10-29WarningsExact identifier
application number: M012
Antigrip Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLPharmadel LLC25a26adf-fd90-bf57-e063-6294a90a40732024-10-29WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Le82dac83-2910-44dc-e053-2995a90a38e12024-10-29WarningsExact identifier
application number: M012
TheraCare Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcared6e789c7-a55a-dc9a-e053-2a95a90a2bdb2024-10-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN33fe0e49-3de5-8afd-e063-6294a90a0ad51
1001081Sudafed OM 0.05 % Nasal SprayPSN33fe0e49-3de5-8afd-e063-6294a90a0ad51
1001081oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Sudafed OM]SBD33fe0e49-3de5-8afd-e063-6294a90a0ad51
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD33fe0e49-3de5-8afd-e063-6294a90a0ad51
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY33fe0e49-3de5-8afd-e063-6294a90a0ad51
1001081Sudafed OM 0.05 % Nasal SpraySY33fe0e49-3de5-8afd-e063-6294a90a0ad51
1001081Sudafed OM 0.5 MG/ML Nasal SpraySY33fe0e49-3de5-8afd-e063-6294a90a0ad51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-368-01505800368011 BOTTLE in 1 CARTON (50580-368-01) / 30 mL in 1 BOTTLE1 bottle2025-06-16NoNoCurrent