FDA.reportPublic FDA data

PREPARATION H MEDICATED WIPES

Product NDC
0573-0556
11-digit product format
005730556
Labeler code
0573
Product ID
0573-0556_4d3a65fc-cb79-5f92-e063-6294a90ad3c3
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
2004-02-02
Substance
WITCH HAZEL
Active strength
5 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-05560573-0556-07DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 MEDICATED WIPES
Listing expiration
2027-12-31

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
8d9961f0-1ecf-d7fb-b6b4-856d636d68e1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0556-07PREPARATION H MEDICATED WIPES1 in 1 PACKETCLOTH112
0573-0556-07PREPARATION H MEDICATED WIPES10 in 1 CARTONCLOTH1012
0573-0556-20PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH4812
0573-0556-95PREPARATION H MEDICATED WIPES60 in 1 POUCHCLOTH6012
0573-0556-95PREPARATION H MEDICATED WIPES3 in 1 CARTONCLOTH312
0573-0556-96PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH4812
0573-0556-96PREPARATION H MEDICATED WIPES2 in 1 CARTONCLOTH212
0573-0556-98PREPARATION H MEDICATED WIPES4 in 1 CARTONCLOTH412
0573-0556-98PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH4812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0556-07EA - Each0573-0556a9a1c89a-644a-4490-8181-6ca3df57990c12014-01-04
0573-0556-20EA - Each0573-055600ac4ec1-2de0-4d5e-97af-bfc98f76c7d212013-02-13
0573-0556-96EA - Each0573-0556bc6a9821-4256-435d-a893-cedf614c083b12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
witch hazelACTIVE INGREDIENT101I4J0U34PREPARATION H MEDICATED WIPES (WITCH HAZEL) CLOTH [WYETH CONSUMER HEALTHCARE]3
witch hazelACTIVE MOIETY101I4J0U34PREPARATION H MEDICATED WIPES (WITCH HAZEL) CLOTH [WYETH CONSUMER HEALTHCARE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0556PREPARATION H MEDICATED WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 9 package rows20240823_8d9961f0-1ecf-d7fb-b6b4-856d636d68e1.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 PadPSN8d9961f0-1ecf-d7fb-b6b4-856d636d68e112
844379witch hazel 500 MG/ML Medicated PadSCD8d9961f0-1ecf-d7fb-b6b4-856d636d68e112
844379witch hazel 50 % Medicated PadSY8d9961f0-1ecf-d7fb-b6b4-856d636d68e112
844379witch hazel 50 % Medicated WipesSY8d9961f0-1ecf-d7fb-b6b4-856d636d68e112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0556-070057305560710 PACKET in 1 CARTON (0573-0556-07) / 1 CLOTH in 1 PACKET10 packet2004-02-020000-00-00NoNoCurrent
0573-0556-200057305562048 CLOTH in 1 POUCH (0573-0556-20) 48 cloth2004-02-020000-00-00NoNoCurrent
0573-0556-95005730556953 POUCH in 1 CARTON (0573-0556-95) / 60 CLOTH in 1 POUCH3 pouch2020-01-01NoNoCurrent
0573-0556-96005730556962 POUCH in 1 CARTON (0573-0556-96) / 48 CLOTH in 1 POUCH2 pouch2004-02-020000-00-00NoNoCurrent
0573-0556-98005730556984 POUCH in 1 CARTON (0573-0556-98) / 48 CLOTH in 1 POUCH4 pouch2021-01-01NoNoCurrent