FDA.reportPublic FDA data

Exchange Select Nasal

Product NDC
55301-388
11-digit product format
553010388
Labeler code
55301
Product ID
55301-388_5bb8b840-13ff-43ec-b303-86e0c2c8e7b3
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Army & Air Force Exchange Service
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-06
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
2026-12-31
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
2026-12-31

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
40d2090d-c332-4dcb-9f43-5ee467e7b3d1Available 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
55301-388-10Exchange Select Nasal1 in 1 CARTONSPRAY, METERED15
55301-388-10Exchange Select Nasal30 mL in 1 BOTTLE, SPRAYSPRAY, METERED305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74EXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWEXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2
WATERINACTIVE INGREDIENT059QF0KO0REXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY [ARMY & AIR FORCE EXCHANGE SERVICE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-388EXCHANGE SELECT NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [ARMY & AIR FORCE EXCHANGE SERVICE]5Current NDC, Legacy NDC, 2 package rows20240906_40d2090d-c332-4dcb-9f43-5ee467e7b3d1.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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dollar GeneralNASAL PHENYLEPHRINE HYDROCHLORIDEDOLGENCORP, INC. (DOLLAR GENERAL & REXALL)e8fd3f0e-a023-4423-8906-17ae02bc083b2026-09-03WarningsExact identifier
application number: M012
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
application number: M012
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
application number: M012
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
application number: M012
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
application number: M012
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
application number: M012
KROGER Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINKROGER COMPANY79d24014-1af7-4d62-bcb8-5bea76a7d6ee2026-09-02WarningsExact identifier
application number: M012
Kroger No DripALLERGY SINUSKROGER COMPANY4788bafb-8866-4a0a-b217-226513799c242026-09-02WarningsExact identifier
application number: M012
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
application number: M012
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
application number: M012
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
application number: M012
KROGER No Drip Nasal Mist Severe CongestionOXYMETAZOLINE HYDROCHLORIDEKROGER COMPANY7256e048-ad69-4322-844d-872f05e6fc8a2026-09-02WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar FreeDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.5c4c8115-cec9-4f2c-9ea9-328535e97b072026-09-01WarningsExact identifier
application number: M012
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEWALMART INC.5e6623c3-6210-4c50-94d6-5554f36876d12026-08-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN40d2090d-c332-4dcb-9f43-5ee467e7b3d15
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD40d2090d-c332-4dcb-9f43-5ee467e7b3d15
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY40d2090d-c332-4dcb-9f43-5ee467e7b3d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-388-10553010388101 BOTTLE, SPRAY in 1 CARTON (55301-388-10) / 30 mL in 1 BOTTLE, SPRAY2014-01-060000-00-00NoNoCurrent