FDA.reportPublic FDA data

nasal

Product NDC
0363-0717
11-digit product format
003630717
Labeler code
0363
Product ID
0363-0717_96a9715b-c44b-4eed-91ba-bf3c03a95ffb
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-31
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
1 g/100mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nasal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1087043Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8db7df1c-46b5-49bd-9002-50b12d58001aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0717-10nasal29.6 mL in 1 BOTTLE, SPRAYSPRAY29.63
0363-0717-10nasal1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0717NASAL (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [WALGREEN COMPANY]3Current NDC, Legacy NDC, 2 package rows20241010_8db7df1c-46b5-49bd-9002-50b12d58001a.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
1087043phenylephrine HCl 1 % Nasal SprayPSN8db7df1c-46b5-49bd-9002-50b12d58001a3
1087043phenylephrine hydrochloride 10 MG/ML Nasal SpraySCD8db7df1c-46b5-49bd-9002-50b12d58001a3
1087043phenylephrine hydrochloride 1 % Nasal SpraySY8db7df1c-46b5-49bd-9002-50b12d58001a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0717-10003630717101 BOTTLE, SPRAY in 1 CARTON (0363-0717-10) / 29.6 mL in 1 BOTTLE, SPRAY2022-01-310000-00-00NoNoCurrent