FDA.reportPublic FDA data

hemorrhoidal

Product NDC
59779-279
11-digit product format
597790279
Labeler code
59779
Product ID
59779-279_1bbf4492-a848-4bac-a1ea-f1ed628606e3
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
CVS Pharmacy
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-11
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
2027-12-31
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
2027-12-31

Active Ingredients#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-279-53hemorrhoidal12 in 1 CARTONSUPPOSITORY125
59779-279-53hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15
59779-279-62hemorrhoidal24 in 1 CARTONSUPPOSITORY245
59779-279-62hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-279-53EA - Each59779-27903425aba-38c2-4716-bd47-f44647468f7a12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
COCOA BUTTERACTIVE MOIETY512OYT1CRRHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-279HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [CVS PHARMACY]5Current NDC, Legacy NDC, 4 package rows20241102_e8a8431b-7851-4da0-a4fa-e242cf3daf2e.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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
application number: M015
Xesso Strawberry Rear Comfort Glide 4% LidocaineLIDOCAINEPremium Natural Cosmetics Incefba09fc-6dd7-0f73-e053-2995a90a628a2025-10-17WarningsExact identifier
application number: M015
medicated padsWITCH HAZELTARGET CORPORATIONacd0d99d-2a77-4227-bebb-c819f4a526662025-10-14WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b0e8d6-4686-960b-e063-6294a90a016e2025-10-09WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
application number: M015
EQUATE HEMORRHOID RELIEFLIDOCAIN 5%WALMART, INCd96e8152-e36e-22fc-e053-2995a90a8b2b2025-10-08WarningsExact identifier
application number: M015
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsExact identifier
application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)LIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.3ffc57c7-5bf4-cba8-e063-6394a90a322f2025-09-29WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation44bb5f25-1114-4bb1-8bcf-40402594abc42025-09-09WarningsExact identifier
application number: M015
Dr. Care Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e456af7-9726-d17e-e063-6394a90ab5602025-09-08WarningsExact identifier
application number: M015
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
application number: M015
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HCLUnifirst First Aid Corporationb3ebf104-cc51-0ef5-e053-2a95a90a25c92025-09-08WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsExact identifier
application number: M015
Pain ReliefANALGESIC MENTHOLUnifirst First Aid Corporation8162d22d-04c0-de07-e053-2991aa0a99752025-09-08WarningsExact identifier
application number: M015
Green Guard BurnLIDOCAINE HCLUnifirst First Aid Corporationb451e96f-fcba-6495-e053-2a95a90a2adf2025-09-08WarningsExact identifier
application number: M015
Lidochill(TM) GelLIDOCAINE HCL 4%, MENTHOL 1%PureTek Corporationd2a9aeb6-8a94-49e7-ab46-84403560b6c82025-09-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e1892de-378b-d2d0-e063-6294a90ad7db2025-09-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNe8a8431b-7851-4da0-a4fa-e242cf3daf2e5
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDe8a8431b-7851-4da0-a4fa-e242cf3daf2e5
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYe8a8431b-7851-4da0-a4fa-e242cf3daf2e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-279-535977902795312 BLISTER PACK in 1 CARTON (59779-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2014-09-110000-00-00NoNoCurrent
59779-279-625977902796224 BLISTER PACK in 1 CARTON (59779-279-62) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2014-09-110000-00-00NoNoCurrent