FDA.reportPublic FDA data

Giltuss Severe Sinus

Product NDC
58552-142
11-digit product format
585520142
Labeler code
58552
Product ID
58552-142_40b8f0e4-90a0-f6b2-e063-6394a90a083b
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline HCl
Dosage form
SPRAY
Route
NASAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Giltuss Severe Sinus
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58552-142-152022-01-31C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-31C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-28C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray
58552-142-152022-01-28C16284748780-1d6a99b39-5e36-a426-e053-dadaa90af4c2Giltuss Severe Sinus Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-142-15Giltuss Severe Sinus1 in 1 CARTONSPRAY16
58552-142-15Giltuss Severe Sinus15 mL in 1 BOTTLE, SPRAYSPRAY156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-142-15ML - Milliliter58552-1423cbe8963-a575-45bf-98a0-e85fd6974b7012021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-142GILTUSS SEVERE SINUS (OXYMETAZOLINE HCL) SPRAY [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_ab7fae3b-1f7d-5d0f-e053-2a95a90a148e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNab7fae3b-1f7d-5d0f-e053-2a95a90a148e6
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDab7fae3b-1f7d-5d0f-e053-2a95a90a148e6
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYab7fae3b-1f7d-5d0f-e053-2a95a90a148e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58552-142-15585520142151 BOTTLE, SPRAY in 1 CARTON (58552-142-15) / 15 mL in 1 BOTTLE, SPRAY2020-07-280000-00-00NoNoCurrent