FDA.reportPublic FDA data

Phenylephrine

Product NDC
21695-524
11-digit product format
216950524
Labeler code
21695
Product ID
21695-524_c40df8f6-8374-4f9b-bfce-94d582470d48
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-02-24
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-524-182019-09-24C16284748780-1934fe258-4cad-48b1-e053-8cdaa90a720aPhenylephrine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-524-18Phenylephrine18 in 1 BLISTER PACKTABLET181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-524-18EA - Each21695-5241cf623a5-8435-4a06-9f9c-934b8037719612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-524PHENYLEPHRINE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110223_c40df8f6-8374-4f9b-bfce-94d582470d48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNc40df8f6-8374-4f9b-bfce-94d582470d481
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDc40df8f6-8374-4f9b-bfce-94d582470d481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-524-182169505241818 in 1 BLISTER PACKHistorical