FDA.reportPublic FDA data

PREPARATION H

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 00:10:42

Label at a glance#

ProductPREPARATION H Maximum Strength
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure11 sections

Storage and handling

Other information store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes

Glycerin 14.4%

Protectant

Phenylephrine HCl 0.25%

Vasoconstrictor

Pramoxine HCl 1%

Local anesthetic

White petrolatum 15%

Protectant

INDICATIONS & USAGE SECTION

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS SECTION

Warnings

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
CREAM

Multi-Symptom
Pain Relief

WITH
ALOE

New Look,
SAME SIZE!

  • Soothing Pain Relief from Burning,
    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E
    and Aloe

1 TUBE | NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H®
HEMORRHOIDAL CREAM

Maximum Strength Pain Relief

Smooth Cream
Formula with Aloe

  1. Rapid, Soothing Pain Relief from Painful
    Burning, Itching and Discomfort
  2. Shrinks Swollen Hemorrhoidal Tissue
  3. Protects Irritated Tissue
  4. Relieves External Discomfort

NET WT. 1.8 OZ (51 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
CREAM

Multi-Symptom
Pain Relief

WITH
ALOE

  • Soothing Pain Relief from Burning,
    Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves External Discomfort
  • Proprietary Blend with Vitamin E
    and Aloe

1 TUBE | NET WT 1.8 OZ (51 g)

PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98
PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN18
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD18
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY18

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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 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 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
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX4
PETROLATUMACTIVE INGREDIENT4T6H12BN9U4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ4
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L54
GLYCERINACTIVE MOIETYPDC6A3C0OX4
PETROLATUMACTIVE MOIETY4T6H12BN9U4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV4
PRAMOXINEACTIVE MOIETY068X84E0564
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U4
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS3114
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
DEXPANTHENOLINACTIVE INGREDIENT1O6C93RI7Z4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
LAURETH-23INACTIVE INGREDIENTN72LMW566G4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP4
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V924
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y4
WATERINACTIVE INGREDIENT059QF0KO0R4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28680573-2868-10, 0573-2868-20, 0573-2868-93, 0573-2868-98

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXPANTHENOL1O6C93RI7ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAURETH-23N72LMW566GIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CREAM / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii+dosage form
20 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii+dosage form
20 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LAURETH-23LAURETH-23N72LMW566GCREAM / TOPICAL0.5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYL GALLATEPROPYL GALLATE8D4SNN7V92CREAM / TOPICALNAExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION / TOPICALNAExact identifier — unii+route
20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
20 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311LOTION / TOPICALNAExact identifier — unii+route
20 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYSTEM / TOPICAL1680 mgExact identifier — unii+route
20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
ndc (package): 0573-2868-93
ndc (package): 0573-2868-20
ndc (package): 0573-2868-98
ndc (package): 0573-2868-10
ndc (product): 0573-2868
ndc11 (package): 00573286820
ndc11 (package): 00573286898
ndc11 (package): 00573286893
ndc11 (package): 00573286810
spl id: 15581b30-e814-550a-e063-6394a90a3aae
spl set id: 7cc03d2e-e708-589a-d9bb-58ebbda989c0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.