FDA.reportPublic FDA data

Pranicura 5

Product NDC
71831-004
11-digit product format
718310004
Labeler code
71831
Product ID
71831-004_01fd300a-994a-4efa-9ec1-2ea6302bef7e
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN, KAOLIN, CALAMINE, MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Pranicura Products LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-18
Substance
GLYCERIN; KAOLIN; ZINC OXIDE; MENTHOL
Active strength
25; 12.5; 12.5; 1 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [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
Pranicura 5
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN25 g/100g
KAOLIN12.5 g/100g
ZINC OXIDE12.5 g/100g
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
24H4NWX5COInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af520a58-3f3c-4d28-a41f-3ed8f74da095Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71831-004-01Pranicura 560 g in 1 JARCREAM605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71831-004PRANICURA 5 (GLYCERIN, KAOLIN, CALAMINE, MENTHOL) CREAM [PRANICURA GROUP LLC]4Current NDC, Legacy NDC, 1 package rows20241202_af520a58-3f3c-4d28-a41f-3ed8f74da095.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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
application number: M015
equate hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLWal-Mart Stores Inc581dd76f-d052-4448-8139-9a2e31891b252024-10-17WarningsExact identifier
application number: M015
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
application number: M015
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
application number: M015
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
application number: M015
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
application number: M015
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
application number: M015
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
application number: M015
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
application number: M015
hemorrhoidal reliefCOCOA BUTTER, PHENYLEPHRINE HCLRite Aid Corporationddafbdca-32c2-49c1-83d3-35b4155958c92024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
application number: M015
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
application number: M015
Soothing Hemorrhoidal Wipes 50 Witch HazelWITCH HAZELThe Honey Pot Company LLC1ea202f5-e228-b3f2-e063-6294a90a16c12024-08-01WarningsExact identifier
application number: M015
Bunnies Bum Hemorrhoidal NumbingLIDOCAINEFloCal Distributors LLC1c809643-0cbe-568f-e063-6394a90a32102024-07-05WarningsExact identifier
application number: M015
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
application number: M015
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
application number: M015
PUREGEN LABS Maximum Strength LidocaineLIDOCAINEAdvanced Rx LLCf4f89582-49e6-424a-bea7-0694484a7c992024-04-11WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71831-004-017183100040160 g in 1 JAR (71831-004-01) 60 g2021-10-180000-00-00NoNoCurrent