Benzocaine

Product NDC: 71888-101
11-digit product format: 718880101
Labeler code: 71888
Product ID: 71888-101_47fac2e8-50dd-cddf-e063-6394a90a9176
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: TOPICAL
Labeler: Bellus Medical, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-06-01
Substance: BENZOCAINE
Active strength: 200 mg/mL
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	71888-101-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	71888-101-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	71888-101-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	71888-101-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71888-101-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71888-101-02	`9bebd1f3094a…`	`5416666fcb17…`

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: Benzocaine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/mL

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
452688	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
60cafbaf-8ec6-46a5-e053-2a91aa0af11f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-10-27	20% Benzocaine Gel
2023-10-27	20% Benzocaine Gel
2020-01-31	20% Benzocaine Gel
2020-01-31	20% Benzocaine Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71888-101-01	Benzocaine	4 mL in 1 PACKET	GEL	4		4
71888-101-02	Benzocaine	12 in 1 BOX	GEL	12		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71888-101	BENZOCAINE GEL [BELLUS MEDICAL, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241120_60cafbaf-8ec6-46a5-e053-2a91aa0af11f.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 79 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF PATCHES	LIDOCAINE	Amerisource Bergen	614f1e56-891f-4620-be10-0c075a1dbc3f	2025-09-11	Warnings	Exact identifier application number: M017
Industrial Itch and Pain Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	R & R Lotion, Inc	236415fc-f923-4a82-b54a-ecaf666dd2e0	2025-09-11	Warnings	Exact identifier application number: M017
Eco Lips Menthol Medicated Lip Balm	MENTHOL	Eco Lips, Inc.	fc4c25d6-6109-dfd8-e053-6394a90a4e91	2025-09-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Encube Ethicals, Inc.	d6f5c0df-6262-4704-bb24-430f66bb2ca8	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Lidocaine Pain Relief Cream	LIDOCAINE CREAM 4%	Kingsway Pharmaceuticals dba NFI, LLC	592811f2-e21c-6a58-e053-2991aa0a69a9	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	282ed5ef-8c2a-4092-9d99-1a7eee7a39e3	2025-09-09	Warnings	Exact identifier application number: M017
LubeLife Climax Control Delay	BENZOCAINE	CC Wellness LLC	e1a98e6d-0c24-75b8-e053-2a95a90ad136	2025-09-09	Warnings	Exact identifier application number: M017
Blue-Emu Maximum Pain Relief	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	c863351a-951b-4f7c-a9c0-4289d702054a	2025-09-09	Warnings	Exact identifier application number: M017
Tiger Balm Neck and Shoulder Rub	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	02a65b25-78b2-4e29-9484-40e2228fb384	2025-09-09	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	e90df2e5-2ef4-47dd-bd74-be9cea6d9d85	2025-09-08	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Unifirst First Aid Corporation	69d6645e-db3c-4dc0-a9a5-e2bc963e2f28	2025-09-08	Warnings	Exact identifier application number: M017
SupreH Arnica Bruise Cream	SUPREH ARNICA REMEDY PLUS BRUISE CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3e41fc0e-54c3-2622-e063-6294a90a13c9	2025-09-07	Warnings	Exact identifier application number: M017
Menthol	MENTHOL	FlexiGo Inc	3607c326-6db0-a2cd-e063-6394a90a9eb6	2025-09-06	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL Cream	PAIN RELIEF CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e08cc87-2385-0838-e063-6394a90abf9b	2025-09-05	Warnings	Exact identifier application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL Cream	CLINICAL CRYOTHERAPY MENTHOL CREAM	Shenzhen Sam Technology Co., Ltd.	3e090b98-1db7-4174-e063-6394a90aa539	2025-09-05	Warnings	Exact identifier application number: M017
ALCEMISTE	LIDOCAINE HCL	Price Team Ventures, LLC	4383faaa-49cf-47b7-83a6-c2a94b6ff9b5	2025-09-05	Warnings	Exact identifier application number: M017
Lansinoh Pain Relieving	LIDOCAINE HCL	Lansinoh Laboratories Inc	b7cf1fdb-946d-a4e8-e053-2995a90a26a8	2025-09-05	Warnings	Exact identifier application number: M017
Sumifun PLANTAR RELIEF ROLL -ON	4% LIDOCAINE, 1% MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	3c9ee60b-548a-979f-e063-6394a90a70b0	2025-09-03	Warnings	Exact identifier application number: M017
Meijer Capsaicin Heat Patch	CAPSAICIN	Meijer Distribution	3c465557-0a4f-fb72-e063-6294a90a1ef2	2025-09-02	Warnings	Exact identifier application number: M017
Cold Therapy	MENTHOL	AHC Ventures Corp DBA Cryoderm	dd95c682-8ddf-43e7-a277-2fca6ec744cc	2025-09-02	Warnings	Exact identifier application number: M017

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
452688	benzocaine 20 % Topical Gel	PSN	60cafbaf-8ec6-46a5-e053-2a91aa0af11f	4
452688	benzocaine 0.2 MG/MG Topical Gel	SCD	60cafbaf-8ec6-46a5-e053-2a91aa0af11f	4
452688	benzocaine 20 % Topical Gel	SY	60cafbaf-8ec6-46a5-e053-2a91aa0af11f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71888-101-01	71888010101	4 mL in 1 PACKET	4 ml				Historical
71888-101-02	71888010102	12 PACKET in 1 BOX (71888-101-02) / 4 mL in 1 PACKET (71888-101-01)	12 packet	2017-06-01	No	No	Current