FDA.reportPublic FDA data

PREPARATION H FOR WOMEN

Product NDC
0573-0559
11-digit product format
005730559
Labeler code
0573
Product ID
0573-0559_47e7adb3-c8ce-b0b9-e063-6394a90a7e0c
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
2014-04-01
Substance
WITCH HAZEL
Active strength
2 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-05590573-0559-10DDiscontinued by firm2026-10-15
excluded packagepackage0573-05590573-0559-41DDiscontinued by firm2026-10-15

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 · 2 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 packagepackage0573-05590573-0559-41DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0573-05590573-0559-10DDiscontinued 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 FOR WOMEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL2 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
1544863Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9099cf4-4e2e-4cf1-a52f-48f8e174cb15Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0559-10PREPARATION H FOR WOMEN10 in 1 CARTONCLOTH1010
0573-0559-10PREPARATION H FOR WOMEN1 in 1 PACKETCLOTH110
0573-0559-40PREPARATION H FOR WOMEN1 in 1 CARTONCLOTH110
0573-0559-40PREPARATION H FOR WOMEN48 in 1 POUCHCLOTH4810
0573-0559-41PREPARATION H FOR WOMEN48 in 1 POUCHCLOTH4810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0559-10EA - Each0573-0559274adda8-7654-49bf-8690-00a86b906eb212024-04-05
0573-0559-40EA - Each0573-0559daffe9e8-c448-47ae-bc58-b4f7192b194b12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WITCH HAZELACTIVE INGREDIENT101I4J0U34PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
WITCH HAZELACTIVE MOIETY101I4J0U34PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
CAPRYL/CAPRAMIDOPROPYL BETAINEINACTIVE INGREDIENT231H3ZT9NEPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2
WATERINACTIVE INGREDIENT059QF0KO0RPREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [PFIZER CONSUMER HEALTHCARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0559PREPARATION H FOR WOMEN (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 5 package rows20240302_a9099cf4-4e2e-4cf1-a52f-48f8e174cb15.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 3 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
Ma Ying Long Musk HemorrhoidsPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.af466f21-c4bc-3b89-e053-2995a90a49f22026-07-20WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc561c601f-c2cd-f09c-e063-6294a90adb452026-07-08WarningsExact identifier
application number: M015
Welmate Numbing ReliefLIDOCAINE 5%YYBA Corp562162c0-7a85-f83c-e063-6294a90a8fc52026-07-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
application number: M015
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
application number: M015
Dr.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
application number: M015
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5b7c4c-feac-4eeb-e063-6294a90a57482026-06-11WarningsExact identifier
application number: M015
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
application number: M015
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544863witch hazel 20 % Medicated PadPSNa9099cf4-4e2e-4cf1-a52f-48f8e174cb1510
1544863witch hazel 200 MG/ML Medicated PadSCDa9099cf4-4e2e-4cf1-a52f-48f8e174cb1510
1544863witch hazel 20 % Medicated PadSYa9099cf4-4e2e-4cf1-a52f-48f8e174cb1510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0559-100057305591010 PACKET in 1 CARTON (0573-0559-10) > 1 CLOTH in 1 PACKET10 packet2014-04-010000-00-00NoNoCurrent
0573-0559-40005730559401 POUCH in 1 CARTON (0573-0559-40) / 48 CLOTH in 1 POUCH1 pouch2014-04-010000-00-00NoNoCurrent
0573-0559-410057305594148 CLOTH in 1 POUCH (0573-0559-41) 48 cloth2014-04-010000-00-00NoNoCurrent