FDA.reportPublic FDA data

Exchange Select Nasal

Product NDC
55301-304
11-digit product format
553010304
Labeler code
55301
Product ID
55301-304_44466ff4-8d04-49c0-9fd1-6e63e9f8c8a7
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Army & Air Force Exchange Service
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-10-28
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
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
Exchange Select 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
aafa9163-f08e-48c9-9ca1-7b72f67d007dAvailable 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
55301-304-10Exchange Select Nasal1 in 1 CARTONSPRAY14
55301-304-10Exchange Select Nasal30 mL in 1 BOTTLESPRAY304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74EXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWEXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1
WATERINACTIVE INGREDIENT059QF0KO0REXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-304EXCHANGE SELECT NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]4Current NDC, Legacy NDC, 2 package rows20240913_aafa9163-f08e-48c9-9ca1-7b72f67d007d.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 136 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact identifier
application number: M012
Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATETopco Associates LLCa2929bcb-fa81-4f15-b087-a9996b5e7d1f2024-11-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNaafa9163-f08e-48c9-9ca1-7b72f67d007d4
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDaafa9163-f08e-48c9-9ca1-7b72f67d007d4
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYaafa9163-f08e-48c9-9ca1-7b72f67d007d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-304-10553010304101 BOTTLE in 1 CARTON (55301-304-10) / 30 mL in 1 BOTTLE1 bottle2011-10-280000-00-00NoNoCurrent