FDA.reportPublic FDA data

Walgreens Hemorrhoidal

Product NDC
0363-0476
11-digit product format
003630476
Labeler code
0363
Product ID
0363-0476_48644028-e157-a563-e063-6294a90aa33f
Type
HUMAN OTC DRUG
Nonproprietary name
Hemorrhoidal Rectal Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Walgreens
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-18
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211; 6.25 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Walgreens Hemorrhoidal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii512OYT1CRR, 04JA59TNSJ
Rxcui1438497

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
0363-0476-122024-02-06C16284748780-1d6a99b39-e7db-a426-e053-dadaa90af4c2WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-242024-02-06C16284748780-1d6a99b3a-00e6-a426-e053-dadaa90af4c2WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-122022-01-28C16284748780-1d6a99b39-e7db-a426-e053-dadaa90af4c2WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-242022-01-28C16284748780-1d6a99b3a-00e6-a426-e053-dadaa90af4c2WALGREENS HEMORRHOIDAL SUPPOSITORIES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0476-12Walgreens Hemorrhoidal2 in 1 CARTONSUPPOSITORY27
0363-0476-13Walgreens Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY67
0363-0476-24Walgreens Hemorrhoidal4 in 1 CARTONSUPPOSITORY47
0363-0476-25Walgreens Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0476WALGREENS HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20250112_2dd710ac-ab04-4a24-826f-b5a44d058168.zip
0363-0476WALGREENS HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [WALGREENS]5Current NDC, Legacy NDC, 2 package rows20250112_ca98dea5-767d-49a8-887b-d96cad487fc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN2dd710ac-ab04-4a24-826f-b5a44d0581687
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNca98dea5-767d-49a8-887b-d96cad487fc47
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD2dd710ac-ab04-4a24-826f-b5a44d0581687
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDca98dea5-767d-49a8-887b-d96cad487fc47
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY2dd710ac-ab04-4a24-826f-b5a44d0581687
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYca98dea5-767d-49a8-887b-d96cad487fc47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0476-12003630476122 BLISTER PACK in 1 CARTON (0363-0476-12) / 6 SUPPOSITORY in 1 BLISTER PACK (0363-0476-13) 2 blister pack2017-09-170000-00-00NoNoCurrent
0363-0476-13003630476136 in 1 BLISTER PACKHistorical
0363-0476-24003630476244 BLISTER PACK in 1 CARTON (0363-0476-24) / 6 SUPPOSITORY in 1 BLISTER PACK (0363-0476-25) 4 blister pack2020-04-240000-00-00NoNoCurrent
0363-0476-25003630476256 in 1 BLISTER PACKHistorical