FDA.reportPublic FDA data

nasal decongestant

Product NDC
50090-5281
11-digit product format
500905281
Labeler code
50090
Product ID
50090-5281_1c42e0eb-ec2f-4b9e-a8d0-68cbf20b1000
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY
Route
NASAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-12
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/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

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-5281-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-5281-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-5281-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-5281-01332a3947898…d4bfe170f9cd…

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
nasal decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e81a937-59e5-4869-8ffb-c758fb37230dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5281-02024-07-23C16284748780-1f386c64a-1a3c-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Nasal Decongestant Drug Facts
50090-5281-02023-01-30C16284748780-1f386c64a-1a3c-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Nasal Decongestant Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5281-0nasal decongestant30 mL in 1 BOTTLE, SPRAYSPRAY304
50090-5281-0nasal decongestant1 in 1 CARTONSPRAY14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5281-0ML - Milliliter50090-52814d7a6f26-f196-46b6-af0b-b159d4e8ccf712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5281NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20240724_0e81a937-59e5-4869-8ffb-c758fb37230d.zip

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 1 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN0e81a937-59e5-4869-8ffb-c758fb37230d4
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD0e81a937-59e5-4869-8ffb-c758fb37230d4
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY0e81a937-59e5-4869-8ffb-c758fb37230d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5281-0500905281001 BOTTLE, SPRAY in 1 CARTON (50090-5281-0) / 30 mL in 1 BOTTLE, SPRAY2020-10-210000-00-00NoNoCurrent