FDA.reportPublic FDA data

PREPARATION H

Product NDC
0573-2880
11-digit product format
005732880
Labeler code
0573
Product ID
0573-2880_12ad4740-7bea-f822-e063-6394a90a0e38
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-05
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211; 6.25 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, 512OYT1CRR
Rxcui1438497

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2880-312023-05-17C16284748780-1d6a99b39-b3f3-a426-e053-dadaa90af4c2Drug Facts
0573-2880-312022-01-28C16284748780-1d6a99b39-b3f3-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2880-31PREPARATION H48 in 1 CARTONSUPPOSITORY4818
0573-2880-31PREPARATION H1 in 1 BLISTER PACKSUPPOSITORY118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2880-31EA - Each0573-2880c7587702-585d-4f4a-b748-54226a6e71c812016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
COCOA BUTTERACTIVE MOIETY512OYT1CRRPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2880PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 2 package rows20240303_a23ded81-78ba-c199-a8f0-aaf360b216ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNa23ded81-78ba-c199-a8f0-aaf360b216ff18
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDa23ded81-78ba-c199-a8f0-aaf360b216ff18
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYa23ded81-78ba-c199-a8f0-aaf360b216ff18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2880-310057328803148 BLISTER PACK in 1 CARTON (0573-2880-31) > 1 SUPPOSITORY in 1 BLISTER PACK48 blister pack2004-01-050000-00-00NoNoCurrent