FDA.reportPublic FDA data

Preparation H

Product NDC
0573-2884
11-digit product format
005732884
Labeler code
0573
Product ID
0573-2884_155865d1-91f7-90d4-e063-6394a90a5945
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine hydrochloride, and witch hazel
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-01
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2884-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2884-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-2884-12bd6a592717d7…303034d00443…

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
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
844379Internal RxNorm lookup
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f370875-0225-47b7-b43f-8fa4600d2a0eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2884-122023-02-08C16284748780-1d6a99b39-6597-a426-e053-dadaa90af4c2Drug Facts
0573-2884-122022-01-28C16284748780-1d6a99b39-6597-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2884-12Preparation H1 in 1 CARTONKIT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
WITCH HAZELACTIVE INGREDIENT101I4J0U34PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
WITCH HAZELACTIVE MOIETY101I4J0U34PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
CAPRYL/CAPRAMIDOPROPYL BETAINEINACTIVE INGREDIENT231H3ZT9NEPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1
WATERINACTIVE INGREDIENT059QF0KO0RPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2884PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 1 package rows20240406_2f370875-0225-47b7-b43f-8fa4600d2a0e.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
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN2f370875-0225-47b7-b43f-8fa4600d2a0e7
844379witch hazel 50 % Medicated PadPSN2f370875-0225-47b7-b43f-8fa4600d2a0e7
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD2f370875-0225-47b7-b43f-8fa4600d2a0e7
844379witch hazel 500 MG/ML Medicated PadSCD2f370875-0225-47b7-b43f-8fa4600d2a0e7
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY2f370875-0225-47b7-b43f-8fa4600d2a0e7
844379witch hazel 50 % Medicated PadSY2f370875-0225-47b7-b43f-8fa4600d2a0e7
844379witch hazel 50 % Medicated WipesSY2f370875-0225-47b7-b43f-8fa4600d2a0e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2884-12005732884121 KIT in 1 CARTON (0573-2884-12) * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR1 kit2015-07-010000-00-00NoNoCurrent