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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
application number: M015
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsExact identifier
application number: M015
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
application number: M015
topcare hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLTopco Associates LLC81a3546b-5099-4b9a-b774-b3e79316b2672025-12-13WarningsExact identifier
application number: M015
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
application number: M015
LMX5LIDOCAINEFerndale Laboratories, Inc.34f8ed6b-4a52-4a99-9c1b-254196dc29b02025-12-10WarningsExact identifier
application number: M015
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
application number: M015
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
application number: M015
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
application number: M015
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
application number: M015
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015
Hazel Perineal Healing FoamWITCH HAZELJiangsu Senwo Medical Technology Co., Ltd.314b75cb-affe-a248-e063-6294a90a47b72025-11-07WarningsExact 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