FDA.reportPublic FDA data

Nostrilla

Product NDC
63736-730
11-digit product format
637360730
Labeler code
63736
Product ID
63736-730_5ab00067-efa6-fc48-e063-6294a90a6499
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Insight Pharmaceuticals LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-08
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 mg/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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63736-73063736-730-02DDiscontinued by firm2026-10-23

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
Nostrilla
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1001058Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86217847-8e2b-48cc-b289-4987fd3aa7c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63736-730-012020-04-10Nostrilla
63736-730-012020-04-10Nostrilla
63736-730-022020-04-10Nostrilla
63736-730-022020-04-10Nostrilla
63736-730-012020-01-31Nostrilla
63736-730-012020-01-31Nostrilla
63736-730-022020-01-31Nostrilla
63736-730-022020-01-31Nostrilla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-730-01Nostrilla1 in 1 CARTONSPRAY, METERED17
63736-730-01Nostrilla15 mL in 1 BOTTLE, SPRAYSPRAY, METERED157
63736-730-02Nostrilla22.5 mL in 1 BOTTLE, SPRAYSPRAY, METERED22.57
63736-730-02Nostrilla1 in 1 CARTONSPRAY, METERED17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
OxymetazolineACTIVE MOIETY8VLN5B44ZYNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
glycineINACTIVE INGREDIENTTE7660XO1CNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
sorbitolINACTIVE INGREDIENT506T60A25RNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2
waterINACTIVE INGREDIENT059QF0KO0RNOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-730NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 4 package rows20241113_86217847-8e2b-48cc-b289-4987fd3aa7c3.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 134 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Childrens Multi-symptom ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.177e3247-402d-98e4-e063-6294a90ae0682024-11-26WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu, CVPCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLETLil' Drug Store Products, Inc.e7a27773-69d6-9e07-e053-2a95a90af8ea2024-11-25WarningsExact identifier
application number: M012
DayTime Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.4361912e-4b56-4743-b11d-acfb94482a2e2024-11-25WarningsExact identifier
application number: M012
NightTime Sinus ReliefACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.413d82d3-a896-4f15-9fca-c1b7b9a1ee632024-11-25WarningsExact identifier
application number: M012
Night Cold Flu Cough and AllergyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.590f4f0d-c8b0-412d-be1e-3eb2ccb29ac02024-11-25WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.cbd3a905-1c41-4cb0-8df6-36784430d6272024-11-25WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7a28d0fe-0e0a-453a-b604-1cc784dd153c2024-11-25WarningsExact identifier
application number: M012
Cough and Cold plusACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdc483d88f-cb0a-4dd6-b3ae-559521782ba62024-11-25WarningsExact identifier
application number: M012
DayTime SinusACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.a0b01aef-4248-4d41-862c-0c8884dfca5e2024-11-25WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.3af20739-6794-42e0-b404-3f0401d10a6d2024-11-25WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.ffc7e1e2-b664-461b-963d-764bad2f983f2024-11-25WarningsExact identifier
application number: M012
NightTime SinusACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.0f3b1404-9252-470a-aa8c-b360c85731f32024-11-25WarningsExact identifier
application number: M012
Maximum Strength-Cough and Chest Congestion DMMAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.d1830989-fe82-4f08-8618-78979fcef5682024-11-25WarningsExact identifier
application number: M012
ASP Daytime PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b84f2392-0b24-4af0-80f7-c45454093f512024-11-25WarningsExact identifier
application number: M012
ASP Nighttime MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.d8756d1f-baf5-412d-a493-a1c051eae3022024-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC508a65ee-42fa-4c0b-b24d-9faac6b0eba72024-11-24WarningsExact identifier
application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu FormulaACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLCcb68eef0-b027-4bf1-b78f-f31844a8c06c2024-11-22WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.de2a64ce-c169-4162-b79e-d3809bea21472024-11-22WarningsExact identifier
application number: M012
12 Hour Nasal Decongestant Extra MoisturizingNASAL SPRAYWinCo Foods LLC13fbde45-958c-455f-b766-f6a34342ee952024-11-21WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a01abac3-c13e-40f2-ae98-34bd6c9b75042024-11-21WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001058Nostrilla 12 Hour 0.05 % Nasal SprayPSN86217847-8e2b-48cc-b289-4987fd3aa7c37
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN86217847-8e2b-48cc-b289-4987fd3aa7c37
1001058oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Nostrilla]SBD86217847-8e2b-48cc-b289-4987fd3aa7c37
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD86217847-8e2b-48cc-b289-4987fd3aa7c37
1001058Nostrilla 0.05 % Nasal SpraySY86217847-8e2b-48cc-b289-4987fd3aa7c37
1001058Nostrilla 0.5 MG/ML Nasal SpraySY86217847-8e2b-48cc-b289-4987fd3aa7c37
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY86217847-8e2b-48cc-b289-4987fd3aa7c37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63736-730-01637360730011 BOTTLE, SPRAY in 1 CARTON (63736-730-01) / 15 mL in 1 BOTTLE, SPRAY2009-06-080000-00-00NoNoCurrent
63736-730-02637360730021 BOTTLE, SPRAY in 1 CARTON (63736-730-02) > 22.5 mL in 1 BOTTLE, SPRAY2009-06-080000-00-00NoNoCurrent