FDA.reportPublic FDA data

Anefrin Nasal

Product NDC
0363-0304
11-digit product format
003630304
Labeler code
0363
Product ID
0363-0304_bde4117e-68de-486f-9be0-718942e03491
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-09-28
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
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
Anefrin Nasal
Brand name suffix
Original
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
85b442dc-1703-4fef-948a-fad7cbe9f224Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0304-10Anefrin NasalOriginal1 in 1 CARTONSPRAY18
0363-0304-10Anefrin NasalOriginal30 mL in 1 BOTTLE, SPRAYSPRAY308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0304-10ML - Milliliter0363-030429e566d2-842f-4835-b2e8-b0f8af18ac7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3
WATERINACTIVE INGREDIENT059QF0KO0RANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0304ANEFRIN NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]8Current NDC, Legacy NDC, 2 package rows20240912_85b442dc-1703-4fef-948a-fad7cbe9f224.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 91 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact identifier
application number: M012
VANACOF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGM Pharmaceuticals, INC2ed699f2-d004-4fa9-8042-6c85a9ff69b62025-11-03WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLVERITYRX, LLC42a05f69-0599-5571-e063-6394a90a37d32025-11-02WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEVERITYRX, LLC42a0e577-a1b6-2c16-e063-6294a90af8e32025-11-02WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpc296efd0-5030-4a26-a9b0-e66423d995dc2025-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu Max Maximum Strength SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates, LLCf7ebe482-cb22-4517-8463-3432cf60071d2025-10-31WarningsExact identifier
application number: M012
Nighttime Cold and Flu Max SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates, LLC787bff76-0ee2-4e7e-b908-876e4a3e3bfc2025-10-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLTrader Joe's Company647dadae-f37a-8399-e053-2991aa0aedb32025-10-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN85b442dc-1703-4fef-948a-fad7cbe9f2248
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD85b442dc-1703-4fef-948a-fad7cbe9f2248
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY85b442dc-1703-4fef-948a-fad7cbe9f2248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0304-10003630304101 BOTTLE, SPRAY in 1 CARTON (0363-0304-10) / 30 mL in 1 BOTTLE, SPRAY1995-09-280000-00-00NoNoCurrent