FDA.reportPublic FDA data

nasal

Product NDC
30142-388
11-digit product format
301420388
Labeler code
30142
Product ID
30142-388_aecf300e-da6a-4e04-b110-bd9acbbc3ded
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Kroger Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-11-20
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

Additional Listing Data#

Finished product
Yes
Brand name base
nasal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK89MJ0S5VY
Rxcui1000990

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
30142-388-10nasal30 mL in 1 BOTTLE, PUMPSPRAY, METERED307
30142-388-10nasal1 in 1 CARTONSPRAY, METERED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30142-388-10ML - Milliliter30142-388dcb6b40f-778e-49db-af8b-945ac222ad6012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HCL) SPRAY [KROGER COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-388NASAL (OXYMETAZOLINE HCL) SPRAY, METERED [KROGER COMPANY]7Current NDC, Legacy NDC, 2 package rows20240906_0a24d98a-5950-49de-8b77-ea880b08d2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN0a24d98a-5950-49de-8b77-ea880b08d2c57
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD0a24d98a-5950-49de-8b77-ea880b08d2c57
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY0a24d98a-5950-49de-8b77-ea880b08d2c57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30142-388-10301420388101 BOTTLE, PUMP in 1 CARTON (30142-388-10) / 30 mL in 1 BOTTLE, PUMP2002-11-200000-00-00NoNoCurrent