FDA.reportPublic FDA data

Equaline Hemorrhoidal

Product NDC
41163-279
11-digit product format
411630279
Labeler code
41163
Product ID
41163-279_ed3a1d99-6362-48d7-a635-3230298111df
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-05
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
Equaline 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-279-53Equaline Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY16
41163-279-53Equaline Hemorrhoidal12 in 1 CARTONSUPPOSITORY126
41163-279-62Equaline Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY16
41163-279-62Equaline Hemorrhoidal24 in 1 CARTONSUPPOSITORY246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-279-53EA - Each41163-2797796da09-050c-4b1d-b845-a2022a782aef12016-10-06
41163-279-62EA - Each41163-2791b1a48b0-24b5-483c-9995-f25de07cae4312016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRREQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJEQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
COCOA BUTTERACTIVE MOIETY512OYT1CRREQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVEQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-279EQUALINE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [UNITED NATURAL FOODS, INC. DBA UNFI]6Current NDC, Legacy NDC, 4 package rows20241025_d29b7824-ff9e-4875-b3de-92721c8add0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNd29b7824-ff9e-4875-b3de-92721c8add0e6
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDd29b7824-ff9e-4875-b3de-92721c8add0e6
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYd29b7824-ff9e-4875-b3de-92721c8add0e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-279-534116302795312 BLISTER PACK in 1 CARTON (41163-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2014-09-050000-00-00NoNoCurrent
41163-279-624116302796224 BLISTER PACK in 1 CARTON (41163-279-62) > 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2014-09-050000-00-00NoNoCurrent