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 57 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LenzaPro Flex	LIDOCAINE/MENTHOL	SOLA Pharmaceuticals	ba498f1d-460b-f4e6-e053-2995a90a5755	2025-12-08	Warnings	Exact identifier application number: M017
LidaFlex	LIDOCAINE	SOLA Pharmaceuticals	b9e49529-13b4-1b0b-e053-2995a90adc7a	2025-12-08	Warnings	Exact identifier application number: M017
Rugby Menthol Hot Cold Patch	MENTHOL	RUGBY LABORATORIES	c68d29c2-9b56-4994-e053-2a95a90ae60e	2025-12-08	Warnings	Exact identifier application number: M017
Neuracin Topical Gel	NEURACIN TOPICAL ANALGESIC GEL	SOLA Pharmaceuticals	c3166926-30c2-2128-e053-2a95a90a0bf2	2025-12-08	Warnings	Exact identifier application number: M017
Triceptin	LIDOCAINE / MENTHOL / METHYL SALICYLATE	SOLA Pharmaceuticals	ef1b98ab-d2db-038c-e053-2995a90a94b4	2025-12-08	Warnings	Exact identifier application number: M017
SynoFlex Patch	SYNOFLEX PATCH	Sola Pharmaceuticals	de2042c4-6c5e-7365-e053-2a95a90ada2a	2025-12-08	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	457c860b-091d-8350-e063-6294a90a2f98	2025-12-08	Warnings	Exact identifier application number: M017
AY BENDITO HEMP	MENTHOL, CAMPHOR	AY BENDITO INTERNATIONAL, INC	457c9bd6-2e72-03e5-e063-6394a90a558c	2025-12-08	Warnings	Exact identifier application number: M017
AY BENDITO HEMP ROLL-ON	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	3e552afc-9305-8825-e063-6294a90a1afe	2025-12-08	Warnings	Exact identifier application number: M017
AY BENDITO HEMP	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	457d89aa-4a84-94a6-e063-6294a90a20c0	2025-12-08	Warnings	Exact identifier application number: M017
Gold Bond Medicated Anti-Itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Gold Bond Co LLC	4a2bd277-47dd-4ae6-9b4b-e0ae9aad226b	2025-12-05	Warnings	Exact identifier application number: M017
Orajel for Cold Sores Double Medicated, Cream	BENZOCAINE AND WHITE PETROLATUM	Church & Dwight Co., Inc.	b8699a40-8464-ca02-e053-2995a90a4260	2025-12-05	Warnings	Exact identifier application number: M017
Thompson Hydrocortisone 1%	HYDROCORTISONE	Thompson	f8740314-7e1f-815e-e053-6294a90a6eae	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING UNSCENTED	LIDOCAINE HCL	Just Brands LLC	453f44e2-9e5b-8695-e063-6394a90a4389	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON COOLING	MENTHOL	Just Brands LLC	453fa1a7-368c-ae50-e063-6294a90a5507	2025-12-05	Warnings	Exact identifier application number: M017
JUST CBD ROLL-ON WARMING	CAMPHOR	Just Brands LLC	4540221f-cf9f-9b6a-e063-6294a90adec3	2025-12-05	Warnings	Exact identifier application number: M017
Gold Bond Extra Strength	MENTHOL	Gold Bond Co LLC	3e84375f-95d3-420c-b222-02a757412592	2025-12-04	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	b3ec09b9-7511-0895-e053-2a95a90a7840	2025-12-04	Warnings	Exact identifier application number: M017
Gold Bond Medicated Pain and Itch Relief	LIDOCAINE HYDROCHLORIDE	Gold Bond Co LLC	d240e9b8-3506-42ab-8a50-05e8d3fac4ff	2025-12-04	Warnings	Exact identifier application number: M017
BLT Skin Cream	BENZOCAINE, LIDOCAINE, TETRACAINE	M2B Pharma LLC	9dc5db9d-9e0a-cd28-e053-2995a90a6bf7	2025-12-04	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