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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Cooling GelPHENYLEPHRINE HCL, WITCH HAZELHaleon US Holdings LLCcebee3f7-8591-e4f7-e66a-e43b4ba3aaf42024-04-05WarningsExact identifier
application number: M015
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
application number: M015
Preparation HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZELHaleon US Holdings LLC2f370875-0225-47b7-b43f-8fa4600d2a0e2024-04-05WarningsExact identifier
application number: M015
PREPARATION HCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa23ded81-78ba-c199-a8f0-aaf360b216ff2024-03-02WarningsExact identifier
application number: M015
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
application number: M015
PREPARATION H HYDROCORTISONEHYDROCORTISONEHaleon US Holdings LLCb8d531eb-4012-0450-0e4b-70a8084640412024-02-29WarningsExact identifier
application number: M015
PREPARATION HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
application number: M015
Numquick AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.b66e7a91-9e35-64dd-e053-2a95a90a8b832024-02-28WarningsExact identifier
application number: M015
Medicated Wipes Hemorroidal Wipes With Witch HazelWITCH HAZELWuhan Zonsen Medical Products Co., Ltd.12441e46-5490-d45c-e063-6394a90a39e32024-02-26WarningsExact identifier
application number: M015
Lidocaine HemorrhoidLIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZELWalgreens Co10a47899-f4a0-66e8-e063-6394a90a11dd2024-02-05WarningsExact identifier
application number: M015
ER HemorrhoidPHENYLEPHRINE HCLEVER READY FIRST AID3cf29fc0-af4d-4610-a426-894601d5e0782024-02-02WarningsExact identifier
application number: M015
RRHOID RAGE HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLCa02a6398-0acd-4aa7-8320-ac586ff12eb32024-01-31WarningsExact identifier
application number: M015
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
application number: M015
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
application number: M015
Prosoria Anti-Itch MoisturizerPRAMOXINE HYDROCHLORIDENuvothera, Inc.3c4b9515-f435-4227-a347-d6508778426d2024-01-10WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCICardinal Health 110 dba LEADERa5a261c2-1f36-c895-e053-2a95a90ab22b2024-01-02WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLProficient Rx LP105095e3-843e-4153-adc9-266dd14929a22024-01-01WarningsExact identifier
application number: M015
Family Wellness HEMORRHOIDGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLFAMILY DOLLAR (Family Wellness)16ceb129-5c0a-428a-a867-cfbbb08bb62a2023-12-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal 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