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 firm2026-10-16
excluded packagepackage0573-05590573-0559-41DDiscontinued by firm2026-10-16

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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact 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