FDA.reportPublic FDA data

nasal

Product NDC
37808-004
11-digit product format
378080004
Labeler code
37808
Product ID
37808-004_91fa3ae3-b502-4320-8167-68893aa41e6d
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-02
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
2027-12-31
Current FDA listing
Yes

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
nasal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c301993-642a-487c-96a2-ebc4ef90dc88Available on FDA.report

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
37808-004-10nasal1 in 1 CARTONSPRAY16
37808-004-10nasal30 mL in 1 BOTTLE, SPRAYSPRAY306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-004NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]6Current NDC, Legacy NDC, 2 package rows20241105_3c301993-642a-487c-96a2-ebc4ef90dc88.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 130 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Vapor SteamCAMPHOR (SYNTHETIC)CVS49da2c40-afc5-5770-e054-00144ff88e882024-12-13WarningsExact identifier
application number: M012
Kroger Daytime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Companye428dd83-c538-2a92-e053-2a95a90a0e162024-12-13WarningsExact identifier
application number: M012
Kroger Nighttime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
application number: M012
Foster and Thrive Childrens Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLC7eaba464-5cdb-4bd4-b272-38fa108658d52024-12-13WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe OriginalOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC1d089074-3969-ce6e-e063-6294a90aa70c2024-12-12WarningsExact identifier
application number: M012
RIGHT REMEDIES Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Incb4fc014c-7c5f-46a4-bf13-57103b6fa0182024-12-11WarningsExact identifier
application number: M012
Diphenhydramine Hydrochloride 25mgDIPHENHYDRAMINE HYDROCHLORIDE 25MGStrive Pharmaceuticals Incb440eb2e-4de9-2b65-e053-2995a90abda82024-12-11WarningsExact identifier
application number: M012
Meijer Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.6933ca9d-a32d-d856-e053-2a91aa0a408e2024-12-10WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEMeijer Distribution Inc.826b5c0d-7a75-bbf0-e053-2a91aa0aebd62024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.09141018-37ba-4c93-9051-1ed129c448c12024-12-10WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola USA Inc.6ac9d95b-f6b9-4515-b126-697f8f8396122024-12-10WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola USA Inc.989d1529-2875-47bf-81df-65494d62be7a2024-12-10WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.82813342-2be2-4731-ae90-dbd5eed667a92024-12-10WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.b640a5d2-a7fe-486d-a65f-e7c993f950d62024-12-10WarningsExact identifier
application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat DropsMENTHOLRicola USA Inc.c3f3c062-55e5-43c1-a016-ee47a7b388a52024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola USA Inc.ee4733b5-6e5a-438a-97da-110f3ef6c8092024-12-10WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola USA Inc.f62fcc38-2d43-40b3-841f-c8eea9ebd1e12024-12-10WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.8a6db093-7e52-443f-8dd6-94867606fef82024-12-10WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola USA Inc.5885343e-4a6e-44f7-87a4-d525991561972024-12-10WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola USA Inc.0baf383c-886d-47ca-8a6d-221298c794462024-12-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3c301993-642a-487c-96a2-ebc4ef90dc886
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3c301993-642a-487c-96a2-ebc4ef90dc886
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3c301993-642a-487c-96a2-ebc4ef90dc886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-004-10378080004101 BOTTLE, SPRAY in 1 CARTON (37808-004-10) / 30 mL in 1 BOTTLE, SPRAY2014-12-020000-00-00NoNoCurrent