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 129 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Cherry Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Companyde01225a-eabb-4972-bf3a-3e5a0e44abef2024-12-17WarningsExact identifier
application number: M012
Rite Aid Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRite Aid Corporation198a666a-3f34-4e4f-89e8-ec7f412f00af2024-12-17WarningsExact identifier
application number: M012
Equate Childrens VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc372e66a6-1f1f-4aa3-a2ed-d215fafee9b92024-12-17WarningsExact identifier
application number: M012
Caring Mill Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFSA Store Inc.caa83419-c332-4b92-b151-22da2fa852892024-12-17WarningsExact identifier
application number: M012
Always Save Chest Congestion Relief GUAFGUAIFENESINValu Merch9d81d88b-2db9-4891-942b-fecb1be961dd2024-12-17WarningsExact identifier
application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.24a75ffa-c2a7-71a9-e063-6394a90a0e252024-12-17WarningsExact identifier
application number: M012
Allergy 36ct, Caseys 4goodDIPHENHYDRAMINE HCL 25MGLil' Drug Store Products, Inc.04b78b23-424d-9762-e063-6394a90a52e32024-12-16WarningsExact identifier
application number: M012
Sinus Relief, Caseys 4goodACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATEDLil' Drug Store Products, Inc.033837c0-fa68-a38d-e063-6394a90a98322024-12-16WarningsExact identifier
application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.cfab9b80-0580-4482-b6e3-0aab875b57972024-12-16WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Lift by 7-ElevenDIPHENHYDRAMINE HCL 25MGLil' Drug Store products, Inc.04c9db9a-95ef-3a48-e063-6294a90a4e8e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Daytime Severe, 24/7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLETLil' Drug Store Products, Inc.05cc7185-d49d-82a3-e063-6294a90a568e2024-12-16WarningsExact identifier
application number: M012
Cold and Flu Nighttime Severe, 24-7 LifeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLLil' Drug Store products, Inc.05d0410f-164e-e7ee-e063-6394a90a2aaa2024-12-16WarningsExact identifier
application number: M012
tussin dm max daytime nighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESINCVS Pharmacy6feaf29e-de06-4c94-912c-a76ea2cbd8c12024-12-16WarningsExact identifier
application number: M012
Leader Childrens Multi Symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER169ff9cf-fcf5-46a6-b460-259421f2ec072024-12-16WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefDEXTROMETHORPHAN HBR, GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADER125eeb3d-0ee2-45bb-81c0-4ca6999798862024-12-16WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mg Liquid GelsDEXTROMETHORPHAN HBRRUGBY LABORATORIEScf3cc387-6642-43fd-999d-688fdaf65d4f2024-12-14WarningsExact identifier
application number: M012
Allergy Relief Dye-Free SoftgelDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACY, INC60b1bb79-3ed1-438b-a27f-f7fbc108d1142024-12-14WarningsExact identifier
application number: M012
Rycontuss Cherry FlavorCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOkendpharma, Inc.c91798fa-48ab-47a0-92da-4d44c2aafde02024-12-13WarningsExact identifier
application number: M012
Mentholatum Lavender Vaporizing RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company6f208c05-617d-492a-a016-e9d6be3c971f2024-12-13WarningsExact identifier
application number: M012
CVS Vapor SteamCAMPHOR (SYNTHETIC)CVS49da2c40-afc5-5770-e054-00144ff88e882024-12-13WarningsExact 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