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
Ingredient	Strength
GLYCERIN	25 g/100g
KAOLIN	12.5 g/100g
ZINC OXIDE	12.5 g/100g
MENTHOL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup
24H4NWX5CO	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
af520a58-3f3c-4d28-a41f-3ed8f74da095	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71831-004-01	Pranicura 5	60 g in 1 JAR	CREAM	60		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71831-004	PRANICURA 5 (GLYCERIN, KAOLIN, CALAMINE, MENTHOL) CREAM [PRANICURA GROUP LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241202_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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum	LIDOCAINE 5%	Telebrands Corp	2774ec41-7366-ac8c-e063-6394a90a1ee2	2024-11-20	Warnings	Exact identifier application number: M015
Walgreens Anorectal Lidocaine Cream	5% LIDOCAINE	Walgreens Company	3052fac7-fd68-43f4-9950-8c07288a6b6d	2024-11-20	Warnings	Exact identifier application number: M015
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Exact identifier application number: M015
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier application number: M015
Granulotion Medicated	MENTHOL, ZINC OXIDE	GL HEALTH, INC.	01701780-b160-415b-b34d-362237179475	2024-10-29	Warnings	Exact identifier application number: M015
rexall hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Dolgencorp Inc	0415c51b-5a12-49d4-8968-0131ddb85545	2024-10-23	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	8155ed74-9412-498f-998c-4a29c46e934f	2024-10-23	Warnings	Exact identifier application number: M015
Leader Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	c4814524-0f4c-4351-a431-5b4b6431fd28	2024-10-23	Warnings	Exact identifier application number: M015
basic care hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amazon.com Services LLC	617d9213-31f0-4c71-be0c-7961b96e5143	2024-10-23	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Safeway	e74b71a1-915d-4e5b-b548-d5cce7945dbd	2024-10-23	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	d29b7824-ff9e-4875-b3de-92721c8add0e	2024-10-23	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Publix Super Markets Inc	a241cb37-7007-4fd8-a12e-f3fc6d6f780e	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Kroger Company	d44ca22a-dc20-454d-99aa-403a8c7a3e00	2024-10-22	Warnings	Exact identifier application number: M015
rugby hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Rugby Laboratories	c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Meijer Distribution Inc	1431397e-3515-4794-a494-70667948e14c	2024-10-18	Warnings	Exact identifier application number: M015
signature care hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Safeway	afcf68cf-f187-44d3-ad91-b1e79b182bc6	2024-10-17	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	H E B	1435432d-5ff2-468b-808d-fb0c99a0717b	2024-10-17	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
24H4NWX5CO	KAOLIN	1332-58-7	KAOLIN
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71831-004-01	71831000401	60 g in 1 JAR (71831-004-01)	60 g	2021-10-18	0000-00-00	No	No	Current