FDA.reportPublic FDA data

hemorrhoidal

Product NDC
56062-279
11-digit product format
560620279
Labeler code
56062
Product ID
56062-279_442b46e3-ab66-431a-83cc-dfecfd6d4077
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Publix Super Markets Inc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-08
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
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
56062-279-53hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY14
56062-279-53hemorrhoidal12 in 1 CARTONSUPPOSITORY124

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-279HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [PUBLIX SUPER MARKETS INC]4Current NDC, Legacy NDC, 2 package rows20241024_a241cb37-7007-4fd8-a12e-f3fc6d6f780e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNa241cb37-7007-4fd8-a12e-f3fc6d6f780e4
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDa241cb37-7007-4fd8-a12e-f3fc6d6f780e4
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYa241cb37-7007-4fd8-a12e-f3fc6d6f780e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-279-535606202795312 BLISTER PACK in 1 CARTON (56062-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2014-09-080000-00-00NoNoCurrent