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

Additional Listing Data#

Finished product
Yes
Brand name base
Preparation H
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui844379, 1438497

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

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