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 firm2026-10-12

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 9 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS PHARMACY, INC.f4020c08-29f6-4609-834e-191ce68851302026-08-14WarningsExact identifier
application number: M012
CVS Severe Cough, Flu Plus Sore Throat HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY95203001-7ca6-4513-83a3-9ef17855bc0f2026-08-14WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY81d26e9c-b713-4fb3-b0a5-68526bad230e2026-08-14WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC212acd54-6ff0-446a-a3bb-3b40e12797112026-08-13WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreen Companye9d0b6f9-e9f3-431c-9f34-4d63108282a12026-08-13WarningsExact identifier
application number: M012
Best Health Caramel Apple Cough DropsMENTHOLBestco58eee9b4-d696-995f-e063-6294a90a5db02026-08-13WarningsExact identifier
application number: M012
Best Health Pumpkin Spice Cough DropsMENTHOLBestco58ef6619-9087-5f41-e063-6294a90a7da62026-08-13WarningsExact identifier
application number: M012
Best Health Bourbon Honey Cough DropsMENTHOLBestco58efdf29-83ea-03b9-e063-6294a90ad3062026-08-13WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLAmazon.com Services LLC9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e2026-08-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC1e3c81b0-05de-4c4a-8579-f301f14626b32026-08-13WarningsExact identifier
application number: M012
Tussin DM Daytime NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd59f6c64-8311-48ba-90d1-8000b04bfcda2026-08-13WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHTACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEKenvue Brands LLC1c5578e6-7e67-c467-e063-6294a90a6e0b2026-08-12WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLCf95220c5-e55c-4271-a267-d004ad2447bf2026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.569b8efa-8458-49f7-a665-6b7016a105052026-08-12WarningsExact identifier
application number: M012
CVS PHARMACY DYE FREE Childrens Allergy ChewsDIPHENHYDRAMINE HCLCVS PHARMACY, INC.e6671e8b-653a-4f4e-b6f3-e31fcd14fbd72026-08-12WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)af35c833-316a-4d21-bd3a-9b71558cadbf2026-08-12WarningsExact identifier
application number: M012
Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores Inccc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c2026-08-11WarningsExact identifier
application number: M012
Best Health Maple Spice Cough DropsMENTHOLBestco58cfdacb-c713-220f-e063-6394a90acbfc2026-08-11WarningsExact identifier
application number: M012
7 Select Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN7-ELEVENf9475972-0cbb-45c5-9e49-09569f1665a72026-08-11WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLL.N.K. International, Inc.6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e32026-08-10WarningsExact 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