FDA.reportPublic FDA data

Walgreen

Product NDC
0363-7151
11-digit product format
003637151
Labeler code
0363
Product ID
0363-7151_446b5b49-9a02-8801-e063-6394a90a3a1a
Type
HUMAN OTC DRUG
Nonproprietary name
Nasal
Dosage form
SPRAY
Route
NASAL
Labeler
WALGREENS CO
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-29
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

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
Walgreen
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
d38f8406-d7b9-472c-a472-58968bbdb993Available 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
0363-7151-15Walgreen1 in 1 CARTONSPRAY17
0363-7151-15Walgreen15 mL in 1 BOTTLE, SPRAYSPRAY157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7151WALGREEN (NASAL) SPRAY [WALGREENS CO]6Current NDC, Legacy NDC, 2 package rows20241113_d38f8406-d7b9-472c-a472-58968bbdb993.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 110 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG HEALTH COLD FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Inc320e4f32-66aa-48be-9afd-fa2b2c217dc12025-07-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.f29da4ca-443d-7035-e053-2a95a90acab82025-07-14WarningsExact identifier
application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS PHARMACYcdc9af7c-3766-4573-9d95-bf217907b9322025-07-11WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILInternational Wholesale Inc398fee3d-7d93-9dbc-e063-6294a90abdcc2025-07-10WarningsExact identifier
application number: M012
HEADACHE RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINEKroger Companybbed29a1-3c52-3531-e053-2995a90a686c2025-07-10WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCb765c82e-5021-4772-8647-c5ebc596bc0a2025-07-10WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyc378acaf-389a-4afb-a4f0-e367a907a4682025-07-10WarningsExact identifier
application number: M012
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
application number: M012
ACTIDOGESIC DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEACTIPHARMA, LLCff8e2565-bce3-4c06-a416-6e8f369f057f2025-07-09WarningsExact identifier
application number: M012
ACTINELDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLCdb0cb6ae-0a4d-4232-805a-f3f3a058261f2025-07-08WarningsExact identifier
application number: M012
HALLS Extra StrongMENTHOLMondelez Global LLC396f93a9-8d2c-2f27-e063-6294a90ab3442025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCaea0335d-75e6-4a90-86a5-f197cf024a112025-07-08WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC0bb006f6-c360-4cd5-81e9-0776d99d79e82025-07-08WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.026e530f-e133-4f20-bac5-354fbb647c9e2025-07-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY, INCf59016f3-a8f8-4c95-9414-01440f0574d92025-07-08WarningsExact identifier
application number: M012
ACTINEL PEDIATRICDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLC6bb92d74-4893-40b8-af58-eb307155e8762025-07-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)776b7c67-56c7-420c-82b2-9a176d9983962025-07-08WarningsExact identifier
application number: M012
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC847014ab-86ae-40c5-8e7f-f1ddea14f1b32025-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGCabinet Health, Inc.26a51b0e-039c-663c-e063-6394a90ad3842025-07-07WarningsExact identifier
application number: M012
EZ Nite SleepDIPHENHYDRAMINE HCLSafeway, Inc.21a68c60-3005-43bb-8ec5-7982239c93f82025-07-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNd38f8406-d7b9-472c-a472-58968bbdb9937
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDd38f8406-d7b9-472c-a472-58968bbdb9937
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYd38f8406-d7b9-472c-a472-58968bbdb9937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-7151-15003637151151 BOTTLE, SPRAY in 1 CARTON (0363-7151-15) / 15 mL in 1 BOTTLE, SPRAY2020-01-290000-00-00NoNoCurrent