FDA.reportPublic FDA data

HEMORRHOIDAL

Product NDC
54162-045
11-digit product format
541620045
Labeler code
54162
Product ID
54162-045_5a2ce02c-f1fe-47e5-97ab-1b9ecbe45151
Type
HUMAN OTC DRUG
Nonproprietary name
HEMORRHOIDAL
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Geritrex Corp.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-29
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; COCOA BUTTER
Active strength
0 g/100g; g/100g
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
54162-045-122020-01-31C16284748780-19d75b9d0-38e3-f424-e053-dadaa90a57ceHemorrhoidal Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-045-12HEMORRHOIDAL2 g in 1 BOX, UNIT-DOSESUPPOSITORY25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-045-12EA - Each54162-045647d2df6-0c28-489a-b750-fbdb7c465fe712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
COCOA BUTTERACTIVE MOIETY512OYT1CRRHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-045HEMORRHOIDAL SUPPOSITORY [GERITREX CORP.]5Legacy NDC, 1 package rows20141016_52e27a92-93e4-4941-b1b3-9de03b5a39c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN52e27a92-93e4-4941-b1b3-9de03b5a39c65
1114865cocoa butter 0.855 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD52e27a92-93e4-4941-b1b3-9de03b5a39c65
1114865cocoa butter 85.5 % / phenylephrine HCl 0.25 % Rectal SuppositorySY52e27a92-93e4-4941-b1b3-9de03b5a39c65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54162-045-12541620045122 g in 1 BOX, UNIT-DOSE2 gHistorical