Nupercainal

Manufacturer: Dr. Reddy's Laboratories Inc.
Effective date: 2016-06-15
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:57:51

Label at a glance#

ProductNupercainal

Active ingredientDibucaine

Label structure10 sections

Dosage and administration

adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. gently dry by patting or blotting with toilet tissue or a soft cloth before applying. apply externally to the affected area up to 3 or 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 20-25°C (68-77°F)

Contacts and useful links#

PhoneLabel contact1-800-790-6417

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dibucaine 1%

Purpose

OTC - PURPOSE SECTION

Hemorrhoidal ointment

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use

OTC - DO NOT USE SECTION

in or near the eyes
in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

do not use more than directed unless directed by a doctor
do not put this product 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: if possible, clean the affected area with mild soap and warm water and rinse thoroughly. gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
apply externally to the affected area up to 3 or 4 times daily
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum

Questions?

OTC - QUESTIONS SECTION

call 1-800-790-6417

PRINCIPAL DISPLAY PANEL - 56.7g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LONGEST LASTING
INGREDIENT

UP TO 8 HOURS

NDC 55741-402-02

NUPERCAINAL^®
HEMORRHOIDAL OINTMENT
DIBUCAINE 1%

Fast Temporary Relief of Pain, Itching,
and Burning Due to Hemorrhoids.

NET WT 2 oz. (56.7g)

Principal Display Panel - 56.7g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238784	dibucaine 1 % Rectal Ointment	PSN	3
901429	NUPERCAINAL 1 % Rectal Ointment	PSN	3
901429	dibucaine 0.01 MG/MG Rectal Ointment [Nupercainal]	SBD	3
238784	dibucaine 0.01 MG/MG Rectal Ointment	SCD	3
238784	dibucaine 1 % Rectal Ointment	SY	3
901429	Nupercainal 0.01 MG/MG Rectal Ointment	SY	3
901429	Nupercainal 1 % Rectal Ointment	SY	3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55741-402-02	2020-09-27	C162847	48780-1	ab0e2407-2a01-f274-e053-dbdaa90a6471	Nupercainal ®
55741-402-02	2020-09-25	C162847	48780-1	ab0e2407-2a01-f274-e053-dbdaa90a6471	Nupercainal ®
55741-402-02	2020-07-22	C162847	48780-1	ab0e2407-2a01-f274-e053-dbdaa90a6471	Nupercainal ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55741-402-02	Nupercainal	56.7 g in 1 TUBE	OINTMENT	56.7		3
55741-402-02	Nupercainal	1 in 1 BOX	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55741-402	NUPERCAINAL (DIBUCAINE) OINTMENT [DR. REDDY'S LABORATORIES INC.]	3	Legacy NDC, 2 package rows	20181220_bcf33951-d3a4-46c5-b208-56adc0011047.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55741-402-02	GM - Gram	55741-402	e70f40a4-816f-4b84-98db-84a552627c01	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dibucaine	ACTIVE INGREDIENT	L6JW2TJG99	1
Dibucaine	ACTIVE MOIETY	L6JW2TJG99	1
acetone sodium bisulfite	INACTIVE INGREDIENT	47VY054OXY	1
lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
light mineral oil	INACTIVE INGREDIENT	N6K5787QVP	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Nupercainal
Dibucaine
acetone sodium bisulfite
lanolin
light mineral oil
water
petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55741-402	55741-402-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dibucaine	L6JW2TJG99	ACTIB
acetone sodium bisulfite	47VY054OXY	IACT
lanolin	7EV65EAW6H	IACT
light mineral oil	N6K5787QVP	IACT
water	059QF0KO0R	IACT
petrolatum	4T6H12BN9U	IACT

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 1 · 46 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	PASTILLE / ORAL	3.6 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	AEROSOL, FOAM / TOPICAL		240 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM, AUGMENTED / TOPICAL	25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	OINTMENT / TOPICAL		1335 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	OIL / AURICULAR (OTIC)		419 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	PASTE / DENTAL		687 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	SUPPOSITORY / VAGINAL	1464.9 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	CREAM / TOPICAL		456 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	EMULSION / TOPICAL		68100 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	SYSTEM / TRANSDERMAL		170 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	TABLET, FILM COATED / ORAL	2.49 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	FILM, EXTENDED RELEASE / TRANSDERMAL	162 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	TABLET, COATED / ORAL	4.8 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	TABLET / ORAL	7.5 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
light mineral oil	LIGHT MINERAL OIL	N6K5787QVP	OIL / TOPICAL		2509 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 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
c7a5c1fa-7822-8e8b-09e6-18156ad6c7bc			bcf33951-d3a4-46c5-b208-56adc0011047	2016-06-15	Warnings	Exact identifier spl id: c7a5c1fa-7822-8e8b-09e6-18156ad6c7bc spl set id: bcf33951-d3a4-46c5-b208-56adc0011047

Reported adverse events (FAERS/openFDA)#

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