Benzodent

Product NDC: 71687-1053
11-digit product format: 716871053
Labeler code: 71687
Product ID: 71687-1053_4fe8bad9-af0f-ad56-e063-6394a90a6e12
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Focus Consumer Healthcare, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-12-08
Substance: BENZOCAINE
Active strength: .2 g/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 · 21 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
2025-04-01 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	71687-1053-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71687-1053-2	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	71687-1053-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71687-1053-2	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	71687-1053-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71687-1053-2	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	71687-1053-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71687-1053-2	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	71687-1053-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71687-1053-2	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	71687-1053-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71687-1053-2	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	71687-1053-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71687-1053-2	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: Benzodent
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	.2 g/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
723562	Internal RxNorm lookup
1112942	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
5fdcb871-d387-6352-e053-2991aa0a09da	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71687-1053-1	2025-04-14	Benzodent
71687-1053-2	2025-04-14	Benzodent
71687-1053-1	2025-01-30	Benzodent
71687-1053-2	2025-01-30	Benzodent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71687-1053-1	Benzodent	7 g in 1 TUBE	CREAM	7	8
71687-1053-1	Benzodent	1 in 1 CARTON	CREAM	1	8
71687-1053-2	Benzodent	28 g in 1 TUBE	CREAM	28	8
71687-1053-2	Benzodent	1 in 1 CARTON	CREAM	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71687-1053	BENZODENT (BENZOCAINE) CREAM [FOCUS CONSUMER HEALTHCARE, LLC]	7	Current NDC, Legacy NDC, 4 package rows	20250416_5fdcb871-d387-6352-e053-2991aa0a09da.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 72 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Care Anti-Itch	HYDROCORTISONE	United Exchange Corp.	8e4d46d8-7084-0666-e053-2995a90ad520	2025-10-21	Warnings	Exact identifier application number: M017
Coralite Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	United Exchange Corp.	69aec845-3d4c-d226-e053-2991aa0afd12	2025-10-21	Warnings	Exact identifier application number: M017
WHITE FLOWER ANALGESIC BALM	CAMPHOR, MENTHOL AND METHYL SALICYLATE	HOE HIN PAK FAH YEOW MANUFACTORY LTD	f3e3b8b5-b12b-49ac-9318-b0c358b136e9	2025-10-21	Warnings	Exact identifier application number: M017
Mountain Ice Sports Recovery	MENTHOL	Mountainside Medical Equipment, Inc.	98638529-3c17-436e-901f-c8aea52bdab6	2025-10-20	Warnings	Exact identifier application number: M017
Lip Clear Lysine Plus	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	21a5b4fb-baed-4766-9820-5c6051c14720	2025-10-20	Warnings	Exact identifier application number: M017
Buzz Away Sting Soothe	MENTHOL	Quantum, Inc.	419e34ea-17b2-ec32-e063-6394a90a603d	2025-10-20	Warnings	Exact identifier application number: M017
Family Care Anti-Itch	HYDROCORTISONE	United Exchange Corp.	deb09e89-9794-89a7-e053-2a95a90abdf8	2025-10-20	Warnings	Exact identifier application number: M017
Numbing Cream	MENTHOL	FlexiGo Inc	41571c8f-332b-f423-e063-6394a90a8897	2025-10-20	Warnings	Exact identifier application number: M017
Soothing Nerve Therapy	MENTHOL	Wise Consumer Products	40829d6b-5005-7ec9-e063-6294a90a970e	2025-10-20	Warnings	Exact identifier application number: M017
Numbing Cream	MENTHOL	FlexiGo Inc	4146fd51-b18c-393d-e063-6294a90a4d9a	2025-10-20	Warnings	Exact identifier application number: M017
Lidocaine 4% Maximum OTC Strength	LIDOCAINE	Cardinal Health 107, LLC	975031df-d46d-4098-b1c0-1c0c92b41995	2025-10-20	Warnings	Exact identifier application number: M017
Cortizone 10 Intensive Healing	HYDROCORTISONE	Chattem, Inc.	bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c	2025-10-20	Warnings	Exact identifier application number: M017
Sting relief pad	BENZOCAINE, ALCOHOL	Guangdong Comfort Medical Products Co., Ltd.	6e905065-10a9-1ded-e053-2a91aa0a46a1	2025-10-19	Warnings	Exact identifier application number: M017
CVS Cold and Hot	MENTHOL	CVS Pharmacy	a44cec95-822a-40b6-e053-2995a90ae31c	2025-10-17	Warnings	Exact identifier application number: M017
Sombra Max	SOMBRA MAX	Sombra Cosmetics Inc.	41623a46-e6e7-907e-e063-6394a90afc4c	2025-10-17	Warnings	Exact identifier application number: M017
POMADA DRAGON PAIN RELIEVING	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	TELEVISA CONSUMER PRODUCTS USA	c283291d-feaa-4f89-8fde-9e3957ea8b9f	2025-10-17	Warnings	Exact identifier application number: M017
Ear Pain MD	LIDOCAINE HYDROCHLORIDE	Eosera Inc	78c4418f-7f0f-447f-a94f-d4c89a081af1	2025-10-17	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	414217c1-ff3a-b556-e063-6394a90aa5db	2025-10-16	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	41422d04-160b-51b2-e063-6294a90ab2b2	2025-10-16	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	41427275-4c35-bbdf-e063-6294a90a14cf	2025-10-16	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
723562	benzocaine 20 % Topical Cream	PSN	5fdcb871-d387-6352-e053-2991aa0a09da	8
1112942	Benzodent 20 % Topical Cream	PSN	5fdcb871-d387-6352-e053-2991aa0a09da	8
1112942	benzocaine 200 MG/ML Topical Cream [Benzodent]	SBD	5fdcb871-d387-6352-e053-2991aa0a09da	8
723562	benzocaine 200 MG/ML Topical Cream	SCD	5fdcb871-d387-6352-e053-2991aa0a09da	8
723562	benzocaine 20 % Topical Cream	SY	5fdcb871-d387-6352-e053-2991aa0a09da	8
1112942	Benzodent 20 % Oromucosal Topical Cream	SY	5fdcb871-d387-6352-e053-2991aa0a09da	8
1112942	Benzodent 200 MG/ML Topical Cream	SY	5fdcb871-d387-6352-e053-2991aa0a09da	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71687-1053-1	71687105301	1 TUBE in 1 CARTON (71687-1053-1) / 7 g in 1 TUBE	1 tube	2017-12-08	0000-00-00	No	No	Current
71687-1053-2	71687105302	1 TUBE in 1 CARTON (71687-1053-2) / 28 g in 1 TUBE	1 tube	2017-12-08	0000-00-00	No	No	Current