Dibucaine

Product NDC: 57896-131
11-digit product format: 578960131
Labeler code: 57896
Product ID: 57896-131_29b472b9-6743-2403-e063-6294a90a22d0
Type: HUMAN OTC DRUG
Nonproprietary name: Dibucaine 1%
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Geri-Care Pharmaceuticals, Corp
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-22
Substance: DIBUCAINE
Active strength: 1 g/100g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dibucaine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIBUCAINE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6JW2TJG99	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238784	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
afe88610-5cac-960e-e053-2a95a90a7ba4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57896-131-01	Dibucaine	28 g in 1 TUBE	OINTMENT	28		4
57896-131-01	Dibucaine	1 in 1 BOX	OINTMENT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-131-01	GM - Gram	57896-131	4a04f944-b7c2-4d7f-89f2-4e034d961b08	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-131	DIBUCAINE (DIBUCAINE 1%) OINTMENT [GERI-CARE PHARMACEUTICALS, CORP]	4	Current NDC, Legacy NDC, 2 package rows	20241222_afe88610-5cac-960e-e053-2a95a90a7ba4.zip

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 20 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Preparation H Cooling Gel	PHENYLEPHRINE HCL, WITCH HAZEL	Haleon US Holdings LLC	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier application number: M015
Preparation H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL	Haleon US Holdings LLC	2f370875-0225-47b7-b43f-8fa4600d2a0e	2024-04-05	Warnings	Exact identifier application number: M015
PREPARATION H	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a23ded81-78ba-c199-a8f0-aaf360b216ff	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H MEDICATED WIPES	WITCH HAZEL	Haleon US Holdings LLC	3b1cfa8a-942f-471e-b7c0-744f83b687a0	2024-03-02	Warnings	Exact identifier application number: M015
PREPARATION H HYDROCORTISONE	HYDROCORTISONE	Haleon US Holdings LLC	b8d531eb-4012-0450-0e4b-70a808464041	2024-02-29	Warnings	Exact identifier application number: M015
PREPARATION H	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Haleon US Holdings LLC	507c08ab-a98b-33fe-e2ac-eb9b9a810d5a	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	27db1d58-4609-4a80-af2f-9e36f10482e1	2024-02-29	Warnings	Exact identifier application number: M015
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier application number: M015
Numquick Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	b66e7a91-9e35-64dd-e053-2a95a90a8b83	2024-02-28	Warnings	Exact identifier application number: M015
Medicated Wipes Hemorroidal Wipes With Witch Hazel	WITCH HAZEL	Wuhan Zonsen Medical Products Co., Ltd.	12441e46-5490-d45c-e063-6394a90a39e3	2024-02-26	Warnings	Exact identifier application number: M015
Lidocaine Hemorrhoid	LIDOCAINE HCL, PHENYLEPHRINE HCL, WITCH HAZEL	Walgreens Co	10a47899-f4a0-66e8-e063-6394a90a11dd	2024-02-05	Warnings	Exact identifier application number: M015
ER Hemorrhoid	PHENYLEPHRINE HCL	EVER READY FIRST AID	3cf29fc0-af4d-4610-a426-894601d5e078	2024-02-02	Warnings	Exact identifier application number: M015
RRHOID RAGE Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	a02a6398-0acd-4aa7-8320-ac586ff12eb3	2024-01-31	Warnings	Exact identifier application number: M015
No More Products	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc	102e7dbb-06dc-f4d1-e063-6394a90aa3eb	2024-01-26	Warnings	Exact identifier application number: M015
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Sarati International, Inc.	0fe10710-ac59-4fc5-e063-6294a90a48fc	2024-01-26	Warnings	Exact identifier application number: M015
Prosoria Anti-Itch Moisturizer	PRAMOXINE HYDROCHLORIDE	Nuvothera, Inc.	3c4b9515-f435-4227-a347-d6508778426d	2024-01-10	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Cardinal Health 110 dba LEADER	a5a261c2-1f36-c895-e053-2a95a90ab22b	2024-01-02	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Proficient Rx LP	105095e3-843e-4153-adc9-266dd14929a2	2024-01-01	Warnings	Exact identifier application number: M015
Family Wellness HEMORRHOID	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	FAMILY DOLLAR (Family Wellness)	16ceb129-5c0a-428a-a867-cfbbb08bb62a	2023-12-11	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6JW2TJG99	DIBUCAINE	85-79-0	DIBUCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238784	dibucaine 1 % Rectal Ointment	PSN	afe88610-5cac-960e-e053-2a95a90a7ba4	4
238784	dibucaine 0.01 MG/MG Rectal Ointment	SCD	afe88610-5cac-960e-e053-2a95a90a7ba4	4
238784	dibucaine 1 % Rectal Ointment	SY	afe88610-5cac-960e-e053-2a95a90a7ba4	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-131-01	57896013101	1 TUBE in 1 BOX (57896-131-01) / 28 g in 1 TUBE	1 tube	2020-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GERI-CARE Dibucaine Ointment 1%	Geri-Care Pharmaceuticals, Corp \| Trifecta Pharmaceuticals USA LLC.	2024-12-20	HUMAN OTC DRUG LABEL	4