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 65 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hempvana Cold As Ice Pain Relief	MENTHOL	Telebrands Corp	95e84bb9-ba2e-5009-e053-2995a90a4362	2025-11-12	Warnings	Exact identifier application number: M017
Lidozall	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	1eb2dfb2-3ad1-488b-aed9-17220e34a10c	2025-11-12	Warnings	Exact identifier application number: M017
Lidozall Plus	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ba3cbb15-f4ed-443e-af43-a758481acb0b	2025-11-12	Warnings	Exact identifier application number: M017
Knee Pain Relief Patch	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Shenzhen Finona Information Technology Co., Ltd	38755738-1a06-fdb4-e063-6294a90aa6eb	2025-11-12	Warnings	Exact identifier application number: M017
Recovery Numb	LIDOCAINE 4%	PURKLENZ FORMULATIONS INC.	e95e38e3-f743-4f5c-abdf-99ba6856e6f7	2025-11-12	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	434c13c2-52ee-000f-e063-6294a90af7e7	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	434d5f92-05c2-d884-e063-6394a90ad28c	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434df0be-49ff-aa56-e063-6394a90a3b5a	2025-11-11	Warnings	Exact identifier application number: M017
TopCare Pain Relief Maximum Strength	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES	b0ae3a7c-52d1-4923-bd50-6bb3749006c8	2025-11-11	Warnings	Exact identifier application number: M017
Comfortcaine	LIDOCAINE HCL	QS Key West Aloe, LLC	831b7c11-e437-4e74-808e-c9c1eb8b82f6	2025-11-11	Warnings	Exact identifier application number: M017
A and E Marathon Delay Serum	DELAY SERUM	Phe Inc	4355d1d8-44fe-aca1-e063-6294a90a85ff	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayStrawberry	ORAL NUMBING SPRAY STRAWBERRY	Phe Inc	4355dab1-a293-ded6-e063-6394a90af9b0	2025-11-11	Warnings	Exact identifier application number: M017
A and E Easy Anal Gel	ANAL NUMBING LUBRICANT	Phe Inc	4355e0f3-65ba-eca6-e063-6394a90ab43c	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayPeppermint	ORAL NUMBING SPRAY MINT	Phe Inc	4355e0d0-1222-d594-e063-6294a90abb29	2025-11-11	Warnings	Exact identifier application number: M017
DermaNumb Analgesic	LIDOCAINE HCL	A.T.S. Laboratories, LLC	0ea46890-45c3-4732-bc47-227f7c67daf1	2025-11-11	Warnings	Exact identifier application number: M017
Derma Numb Pain Relief	LIDOCAINE HCL	A.T.S. Laboratories, LLC	710991ae-8f82-4893-93a7-0ef3f815d132	2025-11-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Exact identifier application number: M017
Jelcaine Sterile	LIDOCAINE HCL JELLY USP, 2%	Brookfield Pharmaceuticals, LLC	1a39d1de-7aa2-3068-e063-6394a90aed85	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	c6e86a0f-6f9b-45b7-86ce-0bb1c198061a	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	97ae1993-7268-4b7f-92e2-6004337d5650	2025-11-10	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