FDA.reportPublic FDA data

Exchange Select Hemorrhoidal

Product NDC
55301-279
11-digit product format
553010279
Labeler code
55301
Product ID
55301-279_18200503-51d0-4d4f-a6b5-821697142a64
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Army & Air Force Exchange Service
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-05
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211; 6.5 mg/1; 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
Exchange Select Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.5 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-279-62Exchange Select Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY13
55301-279-62Exchange Select Hemorrhoidal24 in 1 CARTONSUPPOSITORY243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-279EXCHANGE SELECT HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [ARMY & AIR FORCE EXCHANGE SERVICE]3Current NDC, Legacy NDC, 2 package rows20241025_8155ed74-9412-498f-998c-4a29c46e934f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN8155ed74-9412-498f-998c-4a29c46e934f3
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD8155ed74-9412-498f-998c-4a29c46e934f3
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY8155ed74-9412-498f-998c-4a29c46e934f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-279-625530102796224 BLISTER PACK in 1 CARTON (55301-279-62) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2016-05-050000-00-00NoNoCurrent