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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anefrin Nasal
Brand name suffix
Original
Listing expiration
2026-12-31

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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu plus Congestion NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALMART INC.1236b463-0073-44b5-a516-5b7c06a408872026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact 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