FDA.reportPublic FDA data

Signature Care Nasal Decongestant

Product NDC
21130-801
11-digit product format
211300801
Labeler code
21130
Product ID
21130-801_5e43b82c-f0c4-4389-8f86-2d8c62da7231
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Safeway
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-09
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
Signature Care Nasal Decongestant
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
21130-801-10Signature Care Nasal Decongestant30 mL in 1 BOTTLE, PUMPSPRAY, METERED304
21130-801-10Signature Care Nasal Decongestant1 in 1 CARTONSPRAY, METERED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0RSIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-801SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL) SPRAY, METERED [SAFEWAY]4Current NDC, Legacy NDC, 2 package rows20240906_23f0a5b3-59ae-4eb3-9b7d-e6a492060337.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN23f0a5b3-59ae-4eb3-9b7d-e6a4920603374
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD23f0a5b3-59ae-4eb3-9b7d-e6a4920603374
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY23f0a5b3-59ae-4eb3-9b7d-e6a4920603374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-801-10211300801101 BOTTLE, PUMP in 1 CARTON (21130-801-10) / 30 mL in 1 BOTTLE, PUMP2015-07-090000-00-00NoNoCurrent