FDA.reportPublic FDA data

Oxymetazoline Hydrochloride

Product NDC
51672-2030
11-digit product format
516722030
Labeler code
51672
Product ID
51672-2030_56bb5577-e3d4-ae0b-e063-6394a90ab52c
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-02-25
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
2027-12-31
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
Oxymetazoline Hydrochloride
Brand name suffix
12-Hour
Listing expiration
2027-12-31

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
34a79f8b-32b7-48db-a895-c942cc795292Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2030-3Oxymetazoline Hydrochloride12-Hour30 mL in 1 BOTTLE, SPRAYSPRAY303
51672-2030-3Oxymetazoline Hydrochloride12-Hour1 in 1 CARTONSPRAY13
51672-2030-5Oxymetazoline Hydrochloride12-Hour15 mL in 1 BOTTLE, SPRAYSPRAY153
51672-2030-5Oxymetazoline Hydrochloride12-Hour1 in 1 CARTONSPRAY13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2030-3ML - Milliliter51672-20306438d50f-2bf2-4061-a793-5d3f37fb4b6112012-07-24
51672-2030-5ML - Milliliter51672-203050c5526b-5725-4806-b309-7c4fdb3242e812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOL 1450INACTIVE INGREDIENTOJ4Z5Z32L4OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNOXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
WATERINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]2
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
polyethylene glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94EOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNOXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0ROXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2030OXYMETAZOLINE HYDROCHLORIDE 12-HOUR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20250316_34a79f8b-32b7-48db-a895-c942cc795292.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 141 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8b516736-86ac-47cb-a0ec-038d4c3a00202024-11-07WarningsExact identifier
application number: M012
Tylenol Cold plus Flu plus Cough NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe85e5eb9-3ecf-4784-999e-111e38e306f52024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCef8a846d-4b29-4fd8-a683-fada04d0a2b92024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD Plus FLUACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC9761c807-75a1-4498-a8c6-1f2b1c9ffde62024-11-07WarningsExact identifier
application number: M012
TYLENOL Cold Plus Mucus SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC24ac94e8-b223-424e-bcd2-9c027c8ff9ed2024-11-07WarningsExact identifier
application number: M012
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
application number: M012
Rompe Pecho Max Multi SymptomsACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESINEFFICIENT LABORATORIES INC938e4e47-d2d9-4b0d-bf88-e9f41b5019452024-11-07WarningsExact identifier
application number: M012
topcare sinus nasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCca1fefed-e9d7-430a-9da4-972b1a6fb7862024-11-07WarningsExact identifier
application number: M012
Leader Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderdd82a389-9ec5-4b3f-a9ea-1a56871ebd172024-11-07WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC1a8e2e03-e11b-4da1-945b-e2caadea72432024-11-07WarningsExact identifier
application number: M012
SUDOGEST NASAL DECONGESTANTPSEUDOEPHEDRINE HCLA-S Medication Solutions09feb5f0-c22d-4a1b-97a0-d5767e5f77302024-11-07WarningsExact identifier
application number: M012
up and up childrens allergy meltsDIPHENHYDRAMINE HCLTarget Corporationf98d1d54-8e11-4bb1-825a-ab5447d378472024-11-07WarningsExact identifier
application number: M012
good sense severe day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company44130a1b-63cc-42ac-9590-fdf21a12d1642024-11-07WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLCa5ff1134-8985-4585-8e61-a5fd5f60afeb2024-11-07WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC50528d29-ce8c-4efb-a86c-17246b017db02024-11-07WarningsExact identifier
application number: M012
cooling severe daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacyd4a21760-b2bd-4e26-bff0-6fc1b05d26b32024-11-07WarningsExact identifier
application number: M012
dg health day time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLC60870311-3234-44ba-95dd-09cf4ea3d5082024-11-07WarningsExact identifier
application number: M012
adult dm max cough and chest congestionDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution Inc3a6855c1-da6d-4fa9-81fe-d2e61355989f2024-11-06WarningsExact identifier
application number: M012
oxymetazoline hclOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutionse51dfb62-40d0-4bec-9574-90057cb35bcc2024-11-06WarningsExact identifier
application number: M012
Foster and Thrive Adult Tussin DM MAXDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Services LLC5f6e4d56-4a66-4dbd-97c8-550310dea3582024-11-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN34a79f8b-32b7-48db-a895-c942cc7952923
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD34a79f8b-32b7-48db-a895-c942cc7952923
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY34a79f8b-32b7-48db-a895-c942cc7952923
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNdd196e5a-a791-47ad-aab5-3f2e760f758a2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDdd196e5a-a791-47ad-aab5-3f2e760f758a2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYdd196e5a-a791-47ad-aab5-3f2e760f758a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-2030-3516722030031 BOTTLE, SPRAY in 1 CARTON (51672-2030-3) / 30 mL in 1 BOTTLE, SPRAY2006-02-250000-00-00NoNoCurrent
51672-2030-5516722030051 BOTTLE, SPRAY in 1 CARTON (51672-2030-5) / 15 mL in 1 BOTTLE, SPRAY2006-02-250000-00-00NoNoCurrent