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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eagle Brand Muscle Rub	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	06cb845c-cc53-1f1d-e063-6394a90a8c01	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0ef7c3aa-94a3-9fe9-e063-6394a90ab13d	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	5071f145-49f7-0855-e063-6394a90a8f26	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Refresh	CAMPHOR, MENTHOL	PT. EAGLE INDO PHARMA	09260c31-56a3-07aa-e063-6394a90a95fd	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Muscle Rub	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	5072ad57-9fa7-ddba-e063-6394a90a319b	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	PT. EAGLE INDO PHARMA	09235f26-2262-6ca2-e063-6394a90ad8f1	2026-04-27	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0f333f93-bec6-72d5-e063-6394a90a4e3f	2026-04-27	Warnings	Exact identifier application number: M017
HIP PAIN RELIEF ROLL-ON	LIDOCAINE AND MENTHOL	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	502f1f9e-8552-ca7b-e063-6394a90a7c53	2026-04-24	Warnings	Exact identifier application number: M017
SOMBRA WARM THERAPY	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	de78dba9-53b3-4dbd-9dd2-6a692378da34	2026-04-24	Warnings	Exact identifier application number: M017
Rite Aid Itch Relief	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Rite Aid	e285df43-317c-d862-e053-2a95a90acdce	2026-04-23	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Unflavored	HYDROCORTISONE	Lovely Skin, Inc.	9ff8db07-ad6d-4865-a534-94bd8312957e	2026-04-23	Warnings	Exact identifier application number: M017
DCH Labs Cortisone	HYDROCORTISONE 1%	Derma Care Research Labs	5025f53a-02e0-0f6a-e063-6394a90adbbf	2026-04-23	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Preferred Pharmaceuticals Inc.	e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4	2026-04-22	Warnings	Exact identifier application number: M017
Dr. Carrasco Pain Relief	MENTHOL	Carrasco Enterprises, Inc.	befa8526-f468-428e-a829-422c2ea48612	2026-04-21	Warnings	Exact identifier application number: M017
HealthWise Feminine Anti-itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	4ff88b9e-5869-a1cb-e063-6294a90a87b7	2026-04-21	Warnings	Exact identifier application number: M017
SOMBRA COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	2026-04-21	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	c4c86a8f-1d57-49d2-a65f-acb0dccf2f87	2026-04-21	Warnings	Exact identifier application number: M017
KOXUO Arnica Bruise Cream	ARNICA BRUISE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5003bf83-fa01-b01a-e063-6294a90ad37f	2026-04-21	Warnings	Exact identifier application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% Lidocaine	KT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLON	Clarion Brands LLC	4f82993c-ebc4-5787-e063-6294a90a12d6	2026-04-20	Warnings	Exact identifier application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% Menthol	KT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOL	Clarion Brands LLC	4fe64056-f3c6-bc76-e063-6294a90a7e62	2026-04-20	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