ATOPALM Hemorrhoidal Ointment

Manufacturer: NeoPharm USA | NeoPharm Co., Ltd.
Effective date: 2012-07-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:32:36

Label at a glance#

ProductATOPALM Hemorrhoidal

Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

■ for temporary relief of 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

Do not use if foil seal under cap is broken or missing. ■ 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 externally to the affected area up to 4 times daily, especially at night, in the mo...

Storage and handling

store at 20° – 25°C (68° – 77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Petrolatum 71.9%

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant
Protectant
Vascocontrictor

Uses

INDICATIONS & USAGE SECTION

■ for temporary relief of 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 using if you have

OTC - ASK DOCTOR SECTION

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland

Ask a doctor of 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 the 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 immediately or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use if foil seal under cap is broken or missing.

■ 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 externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
■ for intrarectal use, remove cover from the applicator, attach applicator to tube, lubricate applicator well, then 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.

STORAGE AND HANDLING SECTION

store at 20° – 25°C (68° – 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

COD LIVER OIL, GLYCERIN, LANOLIN, BEES WAX, SQUALANE, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, STEARIC ACID, BUTYLATED HYDROXYTOLUENE, METHYLPARABEN, PARAFFIN, PROPYLPARABEN, PURIFIED WATER, SODIUM BENZOATE, THYMUS VULGARIS (THYME) FLOWER/LEAF OIL, TOCOPHERYL ACETATE.

Questions or information call toll free

OTC - QUESTIONS SECTION

1-855- ATOPALM

ATOPALM Hemorrhoidal Ointment 2oz (51141-0230-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package

Inner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1359113	ATOPALM Hemorrhoidal 14 % / 71.9 % / 0.25 % Rectal Ointment	PSN	2
1313818	mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	2
1359113	mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment [Atopalm Hemorrhoidal]	SBD	2
1313818	mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	2
1359113	Atopalm Hemorrhoidal (mineral oil 14 % / petrolatum 71.9 % / phenylephrine hydrochloride 0.25 % ) Rectal Ointment	SY	2
1313818	mineral oil 14 % / petrolatum 71.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51141-0230-2	2019-11-13	C162847	48780-1	97449f38-bc69-f6ea-e053-dbdaa90aa703	ATOPALM Hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51141-0230-2	ATOPALM Hemorrhoidal	1 in 1 CARTON	OINTMENT	1		2
51141-0230-2	ATOPALM Hemorrhoidal	56 g in 1 TUBE	OINTMENT	56		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51141-0230	ATOPALM HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [NEOPHARM USA]	2	Legacy NDC, 2 package rows	20120719_7983ad30-ee7f-49dc-8ffa-1457d21e590e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	2
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	2
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	2
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA	INACTIVE INGREDIENT	1211AIM8G7	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

ATOPALM Hemorrhoidal
MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
MINERAL OIL
PETROLATUM
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
COD LIVER OIL
GLYCERIN
LANOLIN
SQUALANE
CHOLESTEROL
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA
STEARIC ACID
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
PROPYLPARABEN
PARAFFIN
WATER
SODIUM BENZOATE
THYME OIL
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51141-0230	51141-0230-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
COD LIVER OIL	BBL281NWFG	IACT
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
SQUALANE	GW89575KF9	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA	1211AIM8G7	IACT
STEARIC ACID	4ELV7Z65AP	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PARAFFIN	I9O0E3H2ZE	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
THYME OIL	2UK410MY6B	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT

Source Document#

Source XML

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 6 · 353 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	CREAM, AUGMENTED / TOPICAL		120 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		7 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	52 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	LOTION / TOPICAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAMUSCULAR		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTABLE, LIPOSOMAL / INTRAVENOUS		437 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d3cf0652-d915-4d32-8f38-dc3df1283b2e			7983ad30-ee7f-49dc-8ffa-1457d21e590e	2012-07-18	Warnings	Exact identifier spl id: d3cf0652-d915-4d32-8f38-dc3df1283b2e spl set id: 7983ad30-ee7f-49dc-8ffa-1457d21e590e

Reported adverse events (FAERS/openFDA)#

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