FDA.reportPublic FDA data

PREPARATION H

Product NDC
0573-2868
11-digit product format
005732868
Labeler code
0573
Product ID
0573-2868_15581b30-e814-550a-e063-6394a90a3aae
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, petrolatum, phenylephrine HCl, pramoxine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-07-01
Substance
GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN144 mg/g
PETROLATUM150 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 88AYB867L5
Rxcui1293649

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2868-10PREPARATION HMaximum Strength26 g in 1 TUBECREAM2618
0573-2868-10PREPARATION HMaximum Strength1 in 1 CARTONCREAM118
0573-2868-20PREPARATION HMaximum Strength51 g in 1 TUBECREAM5118
0573-2868-20PREPARATION HMaximum Strength1 in 1 CARTONCREAM118
0573-2868-93PREPARATION HMaximum Strength1 in 1 CARTONCREAM118
0573-2868-93PREPARATION HMaximum Strength26 g in 1 TUBECREAM2618
0573-2868-98PREPARATION HMaximum Strength51 g in 1 TUBECREAM5118
0573-2868-98PREPARATION HMaximum Strength1 in 1 CARTONCREAM118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2868-10GM - Gram0573-2868da836772-1329-4674-9ec4-685ac436e14712012-07-24
0573-2868-20GM - Gram0573-2868b81b8ea3-cdb5-40db-b273-b9c9826d0a3612012-07-24
0573-2868-93GM - Gram0573-28680f2bfcd6-afb4-48ed-b4ba-ad8e2c40dc5812021-12-08
0573-2868-98GM - Gram0573-28686844f3b1-87c3-488d-8a27-72f5e3e0eb2512024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
GLYCERINACTIVE MOIETYPDC6A3C0OXPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PETROLATUMACTIVE MOIETY4T6H12BN9UPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PRAMOXINEACTIVE MOIETY068X84E056PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
DEXPANTHENOLINACTIVE INGREDIENT1O6C93RI7ZPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
LAURETH-23INACTIVE INGREDIENTN72LMW566GPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
WATERINACTIVE INGREDIENT059QF0KO0RPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [PFIZER CONSUMER HEALTHCARE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2868PREPARATION H MAXIMUM STRENGTH (GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL) CREAM [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 8 package rows20240406_7cc03d2e-e708-589a-d9bb-58ebbda989c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN7cc03d2e-e708-589a-d9bb-58ebbda989c018
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD7cc03d2e-e708-589a-d9bb-58ebbda989c018
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY7cc03d2e-e708-589a-d9bb-58ebbda989c018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2868-10005732868101 TUBE in 1 CARTON (0573-2868-10) / 26 g in 1 TUBE1 tube2004-07-010000-00-00NoNoCurrent
0573-2868-20005732868201 TUBE in 1 CARTON (0573-2868-20) / 51 g in 1 TUBE1 tube2004-07-010000-00-00NoNoCurrent
0573-2868-93005732868931 TUBE in 1 CARTON (0573-2868-93) / 26 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent
0573-2868-98005732868981 TUBE in 1 CARTON (0573-2868-98) / 51 g in 1 TUBE1 tube2020-05-120000-00-00NoNoCurrent