FDA.reportPublic FDA data

Ephrine Nose Drops

Product NDC
0363-2023
11-digit product format
003632023
Labeler code
0363
Product ID
0363-2023_090570c3-7d64-5533-e063-6294a90a3d0e
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
NASAL
Labeler
Walgreens
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-15
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
Ephrine Nose Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1234563

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
0363-2023-10Ephrine Nose Drops30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303
0363-2023-10Ephrine Nose Drops1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2023EPHRINE NOSE DROPS (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION/ DROPS [WALGREENS]3Current NDC, Legacy NDC, 2 package rows20231102_b620eb9f-2caf-0942-e053-2a95a90ae48e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234563phenylephrine HCl 1 % Nasal SolutionPSNb620eb9f-2caf-0942-e053-2a95a90ae48e3
1234563phenylephrine hydrochloride 10 MG/ML Nasal SolutionSCDb620eb9f-2caf-0942-e053-2a95a90ae48e3
1234563phenylephrine hydrochloride 1 % Nasal SolutionSYb620eb9f-2caf-0942-e053-2a95a90ae48e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-2023-10003632023101 BOTTLE, DROPPER in 1 CARTON (0363-2023-10) / 30 mL in 1 BOTTLE, DROPPER2021-07-150000-00-00NoNoCurrent