FDA.reportPublic FDA data

PREPARATION H TOTABLES IRRITATION RELIEF WIPES

Product NDC
0573-0558
11-digit product format
005730558
Labeler code
0573
Product ID
0573-0558_2eaa318b-5437-514b-e063-6394a90af0ef
Type
HUMAN OTC DRUG
Nonproprietary name
witch hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-11-21
Substance
WITCH HAZEL
Active strength
5 g/1
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
PREPARATION H TOTABLES IRRITATION RELIEF WIPES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL5 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
844379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1953ec64-20ce-488b-8f14-44e15cc9e720Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0558-01PREPARATION H TOTABLES IRRITATION RELIEF WIPES1 in 1 PACKETCLOTH16
0573-0558-01PREPARATION H TOTABLES IRRITATION RELIEF WIPES50 in 1 CARTONCLOTH506
0573-0558-07PREPARATION H TOTABLES IRRITATION RELIEF WIPES1 in 1 PACKETCLOTH16
0573-0558-07PREPARATION H TOTABLES IRRITATION RELIEF WIPES10 in 1 CARTONCLOTH106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0558-07EA - Each0573-0558569d9476-0316-46f6-ac69-ebf30b0d392912014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WITCH HAZELACTIVE INGREDIENT101I4J0U34PREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
WITCH HAZELACTIVE MOIETY101I4J0U34PREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
CAPRYL/CAPRAMIDOPROPYL BETAINEINACTIVE INGREDIENT231H3ZT9NEPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1
WATERINACTIVE INGREDIENT059QF0KO0RPREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0558PREPARATION H TOTABLES IRRITATION RELIEF WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20250223_1953ec64-20ce-488b-8f14-44e15cc9e720.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 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
application number: M015
ProCure ClamaPlexZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335Twin Med LLC3d366857-5178-9032-e063-6294a90a40f32025-11-01WarningsExact identifier
application number: M015
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
application number: M015
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
application number: M015
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
application number: M015
WorkvieLIDOCAINE HCL, MENTHOLMarketites LLCaebaffb5-58dd-ebd5-e053-2a95a90a14ed2025-10-29WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMPublix Super Markets Inc354a640c-bc7e-45c8-9df0-8b5b01767f5c2025-10-29WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCVS Pharmacy845fc11b-707d-2027-e053-2991aa0a1c8a2025-10-24WarningsExact identifier
application number: M015
Calmol 4ZINC OXIDE AND COCOA BUTTERResical Inc.5516f800-d3fa-4b90-a3eb-c0bdf3183b9b2025-10-24WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmerisourcebergen Drug Corporation231a850a-bad6-9a30-e063-6394a90a0fdc2025-10-24WarningsExact identifier
application number: M015
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
application number: M015
AmericaineBENZOCAINEInsight Pharmaceuticals LLCd13c022f-2f91-40b4-bd66-0cfc0e147a5f2025-10-23WarningsExact identifier
application number: M015
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
application number: M015
Signature Care Medicated CoolingWITCH HAZELBetter Living Brands, LLCb35dc719-a5a2-4839-870d-25313d3f7c9b2025-10-22WarningsExact identifier
application number: M015
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
application number: M015
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
application number: M015
Xesso Rear Comfort GlideLIDOCAINEPREMIUM NATURAL COSMETICS INCe9eb262e-a1c1-7d5c-e053-2a95a90a7c9f2025-10-22WarningsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.41a6d309-2722-1738-e063-6294a90a8a702025-10-21WarningsExact identifier
application number: M015
DERMOSCRIBE ICHYBUMHYDROCORTISONE, CLIOQUINOL, ZINC OXIDEDERMOSCRIBE PTY LTD134a88a1-13e5-4da0-8270-c380b57aaeb72025-10-17WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSN1953ec64-20ce-488b-8f14-44e15cc9e7206
844379witch hazel 500 MG/ML Medicated PadSCD1953ec64-20ce-488b-8f14-44e15cc9e7206
844379witch hazel 50 % Medicated PadSY1953ec64-20ce-488b-8f14-44e15cc9e7206
844379witch hazel 50 % Medicated WipesSY1953ec64-20ce-488b-8f14-44e15cc9e7206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0558-010057305580150 PACKET in 1 CARTON (0573-0558-01) / 1 CLOTH in 1 PACKET50 packet2024-01-01NoNoCurrent
0573-0558-070057305580710 PACKET in 1 CARTON (0573-0558-07) / 1 CLOTH in 1 PACKET10 packet2010-11-210000-00-00NoNoCurrent