FDA.reportPublic FDA data

oxymetazoline hcl

Product NDC
45802-410
11-digit product format
458020410
Labeler code
45802
Product ID
45802-410_999f909c-4119-4f4e-9093-6438801b878d
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-05
Marketing end
2027-02-28
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
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
oxymetazoline hcl

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
a1103cd8-344b-4a65-8a60-3c7be86d01a6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-410-59oxymetazoline hcl30 mL in 1 BOTTLE, SPRAYSPRAY307
45802-410-59oxymetazoline hcl1 in 1 CARTONSPRAY17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-410-59ML - Milliliter45802-41054e747ad-1a30-4db2-8182-ca670b35ec2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWOXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-410OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20240912_a1103cd8-344b-4a65-8a60-3c7be86d01a6.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 40 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leadere7ad8d2d-01fd-40d9-a972-b2ca14cc97fb2026-04-09WarningsExact identifier
application number: M012
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLL.N.K. International, Inc.e20b1093-d77f-4c39-b105-adaa1b82ea762026-04-09WarningsExact identifier
application number: M012
Alka Seltzer Cold Cold and Congestion Severe Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.4f0c1b8e-3fb1-ccf2-e063-6394a90acd152026-04-09WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATELidl US LLCb26ac105-f8e4-4ad0-8a26-9fdf30c017002026-04-09WarningsExact identifier
application number: M012
Wal Dryl Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEWalgreens09de28cd-fa60-4af7-b7cc-cf74c00a35312026-04-09WarningsExact identifier
application number: M012
Tussin DM Max NIGHTTIMEDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companyd10a413e-22a6-4799-8367-5777831756a92026-04-09WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader80d25e23-b108-4eb1-88c7-73fe9da8f9422026-04-09WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR AND GUAIFENESINL.N.K. International, Inc.2fea3533-8218-4875-affe-5b33a22c553a2026-04-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Plus Chest CongestionACETAMINOPHEN, GUAIFENESINKenvue Brands LLC4e60e1ad-4ad4-c329-e063-6294a90ab3182026-04-08WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC4592d547-556f-4eec-8faf-6ff9a92e46c82026-04-08WarningsExact identifier
application number: M012
Goodmeds Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.e24121d2-c9d2-4bbd-869e-eeed7e2bb8812026-04-08WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLStrategic Sourcing Services LLC8460d4f9-8d7b-4ae4-8047-c2010d9c80132026-04-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leaderd2dab450-cf82-4be2-a4e2-630295fb59ab2026-04-08WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens4657c02b-887b-4746-8a78-83a72465e07b2026-04-08WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
application number: M012
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.7959ea00-2a41-4c3c-8c58-85795ebd2afc2026-04-06WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNe51dfb62-40d0-4bec-9574-90057cb35bcc8
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDe51dfb62-40d0-4bec-9574-90057cb35bcc8
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYe51dfb62-40d0-4bec-9574-90057cb35bcc8
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa1103cd8-344b-4a65-8a60-3c7be86d01a67
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa1103cd8-344b-4a65-8a60-3c7be86d01a67
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa1103cd8-344b-4a65-8a60-3c7be86d01a67
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNfd058e2b-5445-e416-e053-6394a90a611b3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDfd058e2b-5445-e416-e053-6394a90a611b3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYfd058e2b-5445-e416-e053-6394a90a611b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-410-59458020410591 BOTTLE, SPRAY in 1 CARTON (45802-410-59) / 30 mL in 1 BOTTLE, SPRAY2005-12-052027-02-28NoNoCurrent