FDA.reportPublic FDA data

PREPARATION H

Manufacturer
Haleon US Holdings LLC | Pf Soins De Santé Sri
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:09:16

Label at a glance#

ProductPREPARATION H
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM
Label structure14 sections

Indications and uses

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

Dosage and administration

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 ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement intrarectal use: remove cover from ap...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

PURPOSES

OTC - PURPOSE SECTION

Protectant

Protectant

Vasoconstrictor

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external and/or intrarectal 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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 ointment.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • intrarectal use:
    • remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
    • thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

PRINCIPAL DISPLAY PANEL - 28 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.

PREPARATION H ®
HEMORRHOIDAL OINTMENT

Prevents Further
Irritation

  • Prompt, Soothing Relief from Painful
    Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort

NET WT 1 OZ (28 g)

Principal Display Panel - 28 g Tube Label
Principal Display Panel - 28 g Tube Label

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®
HEMORRHOIDAL OINTMENT

Prevents Further
Irritation

  • Prompt, Soothing Relief from
    Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort

NET WT 1 OZ (28 g)

Principal Display Panel - 28 g Tube Carton
Principal Display Panel - 28 g Tube Carton

PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
OINTMENT

Prevents Further
Irritation

  • Prompt, Soothing Relief
    from Painful Burning,
    Itching, & Discomfort
  • Shrinks Swollen
    Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal &
    External Discomfort

NET WT 1.0 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867
PRINCIPAL DISPLAY PANEL - 28 g Tube Label - PAA119867

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
OINTMENT

Prevents Further
Irritation

New Look,
SAME SIZE!

  • Prompt, Soothing Relief from Painful
    Burning, Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal & External Discomfort

1 TUBE | NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton - PAA119868

PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
OINTMENT

Prevents Further
Irritation

  • Prompt, Soothing Relief from
    Painful Burning, Itching,
    & Discomfort
  • Shrinks Swollen
    Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal &
    External Discomfort

NET WT 2.0 OZ (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Label
PRINCIPAL DISPLAY PANEL - 57 g Tube Label

PRINCIPAL DISPLAY PANEL - 57g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

HEMORRHOIDAL
OINTMENT

Prevents Further
Irritation

  • Prompt, Soothing Relief from Painful
    Burning, Itching, & Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal & External Discomfort

1 TUBE | NET WT 2 OZ (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN15
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD15
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2871-04PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-04PREPARATION H2 in 1 PACKAGEOINTMENT215
0573-2871-10PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-10PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-20PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-20PREPARATION H57 g in 1 TUBEOINTMENT5715
0573-2871-91PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-91PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-92PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-92PREPARATION H57 g in 1 TUBEOINTMENT5715
0573-2871-93PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-93PREPARATION H28 g in 1 TUBEOINTMENT2815
0573-2871-94PREPARATION H1 in 1 CARTONOINTMENT115
0573-2871-94PREPARATION H57 g in 1 TUBEOINTMENT5715

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2871PREPARATION H (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [HALEON US HOLDINGS LLC]15Current NDC, Legacy NDC, 14 package rows20240302_507c08ab-a98b-33fe-e2ac-eb9b9a810d5a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2871-04GM - Gram0573-28717acfbc40-0747-4dab-93d8-ecd0f52ca0de12024-04-05
0573-2871-10GM - Gram0573-2871f6e5423c-bb14-4f8f-8bbd-1f3679784cc812012-07-24
0573-2871-20GM - Gram0573-2871929f7ea8-767f-4993-9b71-6f6fac08bc0c12012-07-24
0573-2871-93GM - Gram0573-2871bd4ee4db-92a0-4d12-bef1-730e16c84a4f12019-10-07
0573-2871-94GM - Gram0573-28712274dfaf-26cd-4e54-b4eb-c088146d00bd12024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP7
PETROLATUMACTIVE INGREDIENT4T6H12BN9U7
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ7
MINERAL OILACTIVE MOIETYT5L8T28FGP7
PETROLATUMACTIVE MOIETY4T6H12BN9U7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV7
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM7
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U7
CORN OILINACTIVE INGREDIENT8470G57WFM7
GLYCERININACTIVE INGREDIENTPDC6A3C0OX7
LANOLININACTIVE INGREDIENT7EV65EAW6H7
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T7
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH7
THYMEINACTIVE INGREDIENTCW657OBU4N7
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P87
WATERINACTIVE INGREDIENT059QF0KO0R7
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F7

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28710573-2871-10, 0573-2871-20, 0573-2871-04, 0573-2871-91, 0573-2871-92, 0573-2871-93, 0573-2871-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CORN OIL8470G57WFMIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
METHYLPARABENA2I8C7HI9TIACT
PARAFFINI9O0E3H2ZEIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
THYMECW657OBU4NIACT
WHITE WAX7G1J5DA97FIACT
TOCOPHEROLR0ZB2556P8IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
MINERAL OILT5L8T28FGPACTIB
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 · 120 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
40 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FOINTMENT / TOPICAL2100 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
8 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
40 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route
40 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
8 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 HMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLHaleon US Holdings LLC507c08ab-a98b-33fe-e2ac-eb9b9a810d5a2024-02-29WarningsExact identifier
ndc (package): 0573-2871-94
ndc (package): 0573-2871-20
ndc (package): 0573-2871-92
ndc (package): 0573-2871-04
ndc (package): 0573-2871-93
ndc (package): 0573-2871-10
ndc (package): 0573-2871-91
ndc (product): 0573-2871
ndc11 (package): 00573287191
ndc11 (package): 00573287194
ndc11 (package): 00573287192
ndc11 (package): 00573287120
ndc11 (package): 00573287110
ndc11 (package): 00573287193
ndc11 (package): 00573287104
spl id: 128ba16d-dbb2-1073-e063-6394a90a8ba6
spl set id: 507c08ab-a98b-33fe-e2ac-eb9b9a810d5a

Reported adverse events (FAERS/openFDA)#

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