QUALITY CHOICE HEMORRHOIDAL

Manufacturer: CHAIN DRUG MARKETING ASSOCIATION INC
Effective date: 2012-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:31:10

Label at a glance#

ProductQUALITY CHOICE HEMORRHOIDAL

Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL

Label structure14 sections

Storage and handling

Other information Store at 20 o to 25 o C (68 o to 77 o F)

Contacts and useful links#

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Mineral oil 14% .................................................................Protectant

Petrolatum 71.9% .............................................................Protectant

Phenylephrine HCL 0.25% .................................................Vasoconstrictor

Shark liver oil 3.0% ...........................................................Protectant

OTC - PURPOSE SECTION

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

WARNINGS SECTION

Warnings

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not use more than the recommended daily dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

bleeding occurs
condition gets worse or does not get better within 7 days
introduction of the applicator into the rectum causes additional pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a physician 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.

INDICATIONS & USAGE SECTION

Directions

children under 12 years of age: ask a doctor
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
when first opening tube, remove foil seal
for intrarectal use: remove protective cover form applicator and attach to tube
lubricate applicator well, then gently insert applicator into the rectum
thoroughly clean applicator and replace protective cover after each use
apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
also apply ointment to external area

STORAGE AND HANDLING SECTION

Other information

Store at 20^o to 25^oC (68^o to 77^oF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzoic acid, BHA, BHT, methylparaben, paraffin, propylparaben, thyme oil, glyceryl stearate, glycerin, absorb refined lanoline, purified water

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

QC 95128

www.qualitychoice.com

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1544968	mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal Ointment	PSN	1
1544968	mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal Ointment	SCD	1
1544968	mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % / shark liver oil preparation 3 % Rectal Ointment	SY	1

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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
63868-951-57	2019-11-13	C162847	48780-1	97449f38-d526-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-951-57	QUALITY CHOICE HEMORRHOIDAL	1 in 1 CARTON	OINTMENT	1		1
63868-951-57	QUALITY CHOICE HEMORRHOIDAL	57 g in 1 TUBE	OINTMENT	57		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-951	QUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]	1	Legacy NDC, 2 package rows	20120315_8db1cff7-337f-4ed3-a4de-2d392eb908c6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
SHARK LIVER OIL	ACTIVE INGREDIENT	4B24275HEU	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
SHARK LIVER OIL	ACTIVE MOIETY	4B24275HEU	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

QUALITY CHOICE HEMORRHOIDAL
MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL
MINERAL OIL
PETROLATUM
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
SHARK LIVER OIL
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
THYME OIL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-951	63868-951-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
SHARK LIVER OIL	4B24275HEU	ACTIB
BENZOIC ACID	8SKN0B0MIM	IACT
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
THYME OIL	2UK410MY6B	IACT
WATER	059QF0KO0R	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 4 · 237 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CREAM / TOPICAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET, FILM COATED / ORAL	0.4 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SYRUP / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	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	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CAPSULE, LIQUID FILLED / ORAL		4 mg	Exact identifier — unii candidate 24 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
49aae62f-d4e8-4470-8600-da4df73aa5ac			8db1cff7-337f-4ed3-a4de-2d392eb908c6	2012-03-01	Warnings	Exact identifier spl id: 49aae62f-d4e8-4470-8600-da4df73aa5ac spl set id: 8db1cff7-337f-4ed3-a4de-2d392eb908c6

Reported adverse events (FAERS/openFDA)#

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