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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d2ecb86-6bb1-2528-e063-6394a90a8d892025-08-25WarningsExact identifier
application number: M015
Cooling Perineal Pad LinersCOOLING PERINEALELEEO BRANDS LLC29a433bc-a833-ffc7-e063-6294a90a465a2025-08-25WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d3b771f-5e30-b23e-e063-6294a90a3fb22025-08-25WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
application number: M015
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
application number: M015
Lidocaine PatchLIDOCAINE 4%SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS0a31ba9a-8283-4bf8-b6c6-6e331465622f2025-08-20WarningsExact identifier
application number: M015
VBBV Anorectal(Hemorrhoidal) CreamsLIDOCAINEJiashen International Trading Co., Ltd.3cba84ea-5ee0-7ee3-e063-6294a90af11b2025-08-19WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
application number: M015
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
application number: M015
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
application number: M015
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
application number: M015
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
application number: M015
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
application number: M015
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
application number: M015
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
application number: M015
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
application number: M015
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact 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