Quala Topical Anesthetic Gel

Product NDC: 43128-034
11-digit product format: 431280034
Labeler code: 43128
Product ID: 43128-034_4d3b1eba-bdaa-54fd-e063-6394a90a7807
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: DENTAL
Labeler: National Distribution & Contracting, Inc
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-01
Substance: BENZOCAINE
Active strength: 200 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43128-034-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43128-034-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43128-034-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43128-034-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43128-034-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43128-034-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43128-034-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43128-034-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43128-034-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Quala Topical Anesthetic Gel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	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
9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43128-034-30	2025-01-30	C162847	48780-1	2cef2736-8147-d83d-e063-dadaa90ab31f	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43128-034-30	Quala Topical Anesthetic Gel	30 g in 1 JAR	GEL	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43128-034	QUALA TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [NATIONAL DISTRIBUTION & CONTRACTING, INC]	2	Current NDC, Legacy NDC, 1 package rows	20220127_9f94b65d-47e3-9c6b-e053-2a95a90aa1f8.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 22 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	WinCo Foods, LLC	9417b340-942b-48bf-bbfd-4cd5154082b9	2025-02-12	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	b291811f-8fac-45e2-a9a2-b3ecc0813d0d	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	fea30599-5e3b-4163-9660-d41b3fcee143	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	3be68966-199c-481e-8b9e-e994c41fd96a	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	ccdee0cc-2bc9-4165-a411-02f4f900d86a	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	69c4dd1b-a0db-4495-bfc3-faffdfdf59bf	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	d5ef3e65-35e8-4323-9f33-3076b561e105	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	746df21c-e92e-4a71-b1c6-baf99785a43e	2025-01-29	Warnings	Exact identifier application number: M022
NRG Topical Anesthetic	BENZOCAINE	IQ Dental Supply, LLC	2345e614-c7b6-448c-8e07-31700bade91c	2025-01-29	Warnings	Exact identifier application number: M022
UltraCare Anesthetic Gel	BENZOCAINE	The Belport Company, Inc. DBA Gingi-Pak	142062ca-6f8f-78d2-e063-6294a90a19d8	2025-01-29	Warnings, Adverse reactions	Exact identifier application number: M022
CHLORASEPTIC MAX	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	edd12a2d-aa27-4f15-9ce6-862e4b6144c4	2025-01-23	Warnings	Exact identifier application number: M022
meijer Sensitive FRESH MINT	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	bea36d55-1a5d-40c0-b422-92fb36043ee6	2025-01-23	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	159d412c-6d1a-45d4-88c0-8c93960f946e	2025-01-21	Warnings	Exact identifier application number: M022
SEACALL Mouthwash	MOUTHWASH	Guangdong Quadrant Ecological Technology Co., Ltd.	2c1a7eed-6a7c-eeb2-e063-6394a90aafcc	2025-01-19	Warnings	Exact identifier application number: M022
BENZOCAINE Raspberry	BENZOCAINE	Darby Dental Supply, LLC	dd805400-26c5-4c18-ade2-821298233f9b	2025-01-17	Warnings	Exact identifier application number: M022
KAYLAAN	ZERO WASTE REFILL FOR TOOTHPASTE	Kaylaan LLC	c68fd8c7-7ec3-cc3f-e053-2995a90a4395	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	d22f7776-1b3c-4744-bcfe-8d9597218d73	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9c6a26e8-1253-49f7-9ce2-45c0d39f05c5	2025-01-16	Warnings	Exact identifier application number: M022
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	48178733-7433-41ec-b178-1314e0edab1a	2025-01-16	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	3
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	3
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43128-034-30	43128003430	30 g in 1 JAR (43128-034-30)	30 g	2019-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quala Topical Anesthetic Gel - National Distribution & Contracting, Inc	National Distribution & Contracting, Inc	2026-03-17	HUMAN OTC DRUG LABEL	3