FDA.reportPublic FDA data

hemorrhoidal

Product NDC
30142-279
11-digit product format
301420279
Labeler code
30142
Product ID
30142-279_7b8961b4-15ce-4e07-9292-5c63c16ed7d8
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Kroger Company
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-23
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
512OYT1CRRInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d44ca22a-dc20-454d-99aa-403a8c7a3e00Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-279-62hemorrhoidal24 in 1 CARTONSUPPOSITORY245
30142-279-62hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-279HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20241024_d44ca22a-dc20-454d-99aa-403a8c7a3e00.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
Ma Ying Long Musk HemorrhoidsPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.af466f21-c4bc-3b89-e053-2995a90a49f22026-07-20WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
application number: M015
Welmate Numbing ReliefLIDOCAINE 5%YYBA Corp562162c0-7a85-f83c-e063-6294a90a8fc52026-07-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
application number: M015
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
application number: M015
Dr.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
application number: M015
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5b7c4c-feac-4eeb-e063-6294a90a57482026-06-11WarningsExact identifier
application number: M015
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
application number: M015
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNd44ca22a-dc20-454d-99aa-403a8c7a3e005
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDd44ca22a-dc20-454d-99aa-403a8c7a3e005
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYd44ca22a-dc20-454d-99aa-403a8c7a3e005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-279-623014202796224 BLISTER PACK in 1 CARTON (30142-279-62) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2014-08-230000-00-00NoNoCurrent