FDA.reportPublic FDA data

Phenylephrine HCl

Product NDC
50090-5606
11-digit product format
500905606
Labeler code
50090
Product ID
50090-5606_ff825a2d-2bc7-41b8-807f-484d8b84fa2b
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-09
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
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
Phenylephrine HCl
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1049182

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5606-02023-02-07C16284748780-1f386c64a-06f8-0266-e053-dadaa90a7c1aRugby 44-453
50090-5606-02023-01-30C16284748780-1f386c64a-06f8-0266-e053-dadaa90a7c1aRugby 44-453

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5606-0Phenylephrine HClMaximum Strength2 in 1 CARTONTABLET, FILM COATED25
50090-5606-0Phenylephrine HClMaximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5606-0EA - Each50090-5606ae7c7f79-d21a-4046-81f2-fc15905c2f8612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5606PHENYLEPHRINE HCL MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231210_fcb769d0-aa45-48eb-acd0-2247b392f9fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNfcb769d0-aa45-48eb-acd0-2247b392f9fe5
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDfcb769d0-aa45-48eb-acd0-2247b392f9fe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5606-0500905606002 BLISTER PACK in 1 CARTON (50090-5606-0) / 18 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-07-300000-00-00NoNoCurrent