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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbsure LIDOCAINE	LIDOCAINE 4%	Hambli Limited	43a65a12-ef2a-4608-e063-6394a90a82ea	2026-01-31	Warnings	Exact identifier application number: M017
Collajoint Lidocaine Pain Relief Gel Patch	LIDOCAINE PAIN RELIEF GEL PATCH	Henan Enokon Medical Instrument Co., Ltd.	44e27e7f-992f-d194-e063-6294a90a94e4	2026-01-31	Warnings	Exact identifier application number: M017
CAPSAICIN HEAT Patch	CAPSAICIN HEAT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac2045-2c07-af9a-e063-6294a90a052a	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ac6a7b-25d3-6dc4-e063-6394a90a99b6	2026-01-31	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED Patch	COLD AND HOT MEDICATED PATCH	Henan Enokon Medical Instrument Co., Ltd.	49aca763-be2a-cf38-e063-6294a90a092e	2026-01-31	Warnings	Exact identifier application number: M017
PAIN RELIEF HOT Patch	PAIN RELIEF HOT PATCH	Henan Enokon Medical Instrument Co., Ltd.	49ad128a-0f4c-085a-e063-6294a90ac9bb	2026-01-31	Warnings	Exact identifier application number: M017
Walgreens Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walgreen Company	3557d2e9-714a-4066-aa73-ea9e3363e574	2026-01-30	Warnings	Exact identifier application number: M017
Alveora HEMORRHOID MASTER	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	4996f96a-898e-de01-e063-6394a90a3907	2026-01-30	Warnings	Exact identifier application number: M017
Sunburn Relief	LIDOCAINE HCL 0.5%	Rite Aid Corporation	b67af0c7-1ae8-4494-bb0e-d7f66ebca352	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS	CAPSAICIN	OL PHARMA TECH,LLC	48fdf9dc-05df-866d-e063-6294a90ae03a	2026-01-30	Warnings	Exact identifier application number: M017
ROCKTAPE GO Kinesiology Tape and Analgesic	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	b779c7d8-dbe6-472f-9282-6cced25cfd2e	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	de5f7add-1f2b-438a-ac17-753ebb53e697	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll-On	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	5a2d9c3a-67fc-4c1a-b1e8-62a93880397a	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Dr. Collado	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A	c0dad2db-7c96-49b8-a451-bf8cfa7f798b	2026-01-29	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Implus Footcare, LLC	3121c7f7-d7e5-4ca9-9057-03edf9c94c56	2026-01-29	Warnings	Exact identifier application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl Salicylate	MENTHOL, METHYL SALICYLATE	Laboratorios Dr. Collado, S.A.	87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d	2026-01-29	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone Cream Plus	HYDROCORTISONE	Rooftop Consumer Health, Inc.	fe334cae-e019-4397-8498-df3c923ae8b5	2026-01-29	Warnings	Exact identifier application number: M017
Red Oil Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL, PHENOL	The Red Oil Company Inc	1e36579a-72da-46ba-ac72-5960a11c0880	2026-01-29	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM, MENTHOL	NATURES FORMULAE HEALTH PRODUCTS LTD.	498a5e2a-4de0-561c-e063-6394a90ac05c	2026-01-29	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET POTENT PAIN RELIEF	45c76956-db3f-3e84-e063-6394a90adce1	2026-01-29	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