FDA.reportPublic FDA data

Up and up nasal

Product NDC
11673-304
11-digit product format
116730304
Labeler code
11673
Product ID
11673-304_9211198c-c1b8-493d-b7ee-3a9073815388
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Target Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-08-12
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
2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct11673-304DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11673-30411673-304-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
Up and up nasal
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
0c246c11-eadd-4ac6-bd58-5fdb151e06d6Available 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
11673-304-10Up and up nasal1 in 1 CARTONSPRAY16
11673-304-10Up and up nasal30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-304-10ML - Milliliter11673-30430f015ce-ff3a-409b-8728-b8e1b235172612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7UP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74UP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4
WATERINACTIVE INGREDIENT059QF0KO0RUP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-304UP AND UP NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [TARGET CORPORATION]6Current NDC, Legacy NDC, 2 package rows20240912_0c246c11-eadd-4ac6-bd58-5fdb151e06d6.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 168 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen3dc293c9-736b-4bd8-b993-ff83b9909bcd2024-02-23WarningsExact identifier
application number: M012
Childrens Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health (Leader) 7000010cc7d67-30c4-4451-bf74-78abae3c8e252024-02-23WarningsExact identifier
application number: M012
Nasal Spray, 24-7 for LifeOXYMETAZOLINE HYDROCHLORIDE 0.05%Lil' Drug Store Products, Inc.11d27c75-fd95-f9da-e063-6394a90ac6b02024-02-20WarningsExact identifier
application number: M012
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
application number: M012
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
application number: M012
CVS Health COUGH SUPPRESSANT SOFTGELDEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy, Inc.f676dfeb-fba8-419d-8a47-c3880e4100cc2024-02-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLRejoice International Corp.104e1a38-3472-b9e2-e063-6294a90a38cf2024-02-01WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.104f5b07-eed2-566c-e063-6294a90a65052024-02-01WarningsExact identifier
application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCe5ef7b85-feee-44a7-bd0e-ed91352c74342024-01-31WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
application number: M012
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN0c246c11-eadd-4ac6-bd58-5fdb151e06d66
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD0c246c11-eadd-4ac6-bd58-5fdb151e06d66
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY0c246c11-eadd-4ac6-bd58-5fdb151e06d66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11673-304-10116730304101 BOTTLE, SPRAY in 1 CARTON (11673-304-10) / 30 mL in 1 BOTTLE, SPRAY2009-08-12NoNoCurrent