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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact 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