Brace Relief

Product NDC: 60306-115
11-digit product format: 603060115
Labeler code: 60306
Product ID: 60306-115_c4d6e935-9aaa-430e-ae72-51d4c84fcbf4
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: ORAL
Labeler: InfaLab,Inc
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-03
Substance: BENZOCAINE
Active strength: 9 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	60306-115		I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	60306-115	60306-115-05	I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Brace Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	9 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1547591	Internal RxNorm lookup
1547593	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
d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60306-115-05	2022-04-11	C162847	48780-1	9855e2a2-3c21-60a7-e053-dbdaa90a05bd	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-05	2019-12-13	C162847	48780-1	9855e2a2-3c21-60a7-e053-dbdaa90a05bd	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-05	2019-11-27	C162847	48780-1	9855e2a2-3c21-60a7-e053-dbdaa90a05bd	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60306-115-05	Brace Relief	0.3 mL in 1 TUBE	GEL	0.3		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Clove Oil	INACTIVE INGREDIENT	578389D6D0	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Myrrh	INACTIVE INGREDIENT	JC71GJ1F3L	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Peppermint Oil	INACTIVE INGREDIENT	AV092KU4JH	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Phenol	INACTIVE INGREDIENT	339NCG44TV	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60306-115	BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]	11	Current NDC, Legacy NDC, 1 package rows	20241010_d7e57d67-4234-44a9-bbd3-72e99cd5bdb3.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balma Septic Antiseptic Hand Wash	BENZALKONIUM CHLORIDE	Rochester Midland Corporation	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528	2025-01-10	Warnings	Exact identifier application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380	CHLOROXYLENOL	ABC Compounding Co., Inc.	efa3938f-64de-77ba-e053-2a95a90ac840	2025-01-10	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	64aa660d-2d69-48e8-bd0d-4876815d89ff	2025-01-08	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Water-Jel Technologies	412928a1-3708-4fa8-99c5-aaa2b079cf6e	2025-01-06	Warnings	Exact identifier application number: M004
AVON HeXashield Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Tai Guk Pharm. Co., Ltd.	8e0cb861-d8aa-1f71-e053-2a95a90aaa88	2025-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA LLC	087694c2-4b1b-e293-e063-6294a90a961f	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	TRIFECTA PHARMACEUTICALS USA LLC	0c017b10-29b6-e30f-e063-6294a90a8a3c	2024-12-31	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	0bf08cf6-be3f-f9aa-e063-6294a90a4393	2024-12-31	Warnings	Exact identifier application number: M004
Single Antibiotic with Bacitracin	BACITRACIN ZINC	Randob Labs Ltd.	2a807f1b-986f-a9ea-e063-6394a90aed25	2024-12-30	Warnings	Exact identifier application number: M004
Tripleantibioticapainscaritch	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	935106c6-8a9e-07fa-e053-2a95a90a2484	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	00c52a31-9bfa-a8bf-e063-6294a90ac4d7	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE	Trifecta Pharmaceuticals Usa Llc	d04b397c-1608-4fd9-be28-ef7285d6a996	2024-12-20	Warnings	Exact identifier application number: M004
Tripleantibioticointmentandpainrelief	FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE	Trifecta Pharmaceutical USA LLC	91575333-5268-5d8f-e053-2a95a90a7a89	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Max Strength Antibiotic plus pain relief	PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Pharmacy Value Alliance LLC	9767821e-054b-3bd3-e053-2a95a90a4b0e	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab843664-a1e0-6716-e053-2995a90a2063	2024-12-20	Warnings	Exact identifier application number: M004
Premier Value Bacitracin Zinc	BACITRACIN ZINC	Pharmacy Value Alliance LLC	99d789be-aa85-0917-e053-2a95a90acd13	2024-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Premier Value Alliance LLC.	ab863d90-1a8f-3c1f-e053-2a95a90aa0a7	2024-12-20	Warnings	Exact identifier application number: M004
Family Wellness First Aid Antibiotic	FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE	Trifecta Pharmaceuticals USA, LLC	9157681a-3ed1-096e-e053-2a95a90a05e3	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Original	FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B	Trifecta Pharmaceuticals USA LLC.	915759af-0d4f-6a87-e053-2a95a90acbd6	2024-12-18	Warnings	Exact identifier application number: M004
Family Wellness Pain Scar Itch	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Trifecta Pharmaceutical USA LLC	9e507ec5-310d-3a21-e053-2a95a90a15a6	2024-12-18	Warnings	Exact identifier application number: M004

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
1547591	benzocaine 9 % Oral Gel	PSN	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547593	Brace Relief 9 % Oral Gel	PSN	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547593	benzocaine 0.09 MG/MG Oral Gel [Brace Relief]	SBD	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547591	benzocaine 0.09 MG/MG Oral Gel	SCD	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547591	benzocaine 9 % Oral Gel	SY	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547593	Brace Relief 0.09 MG/MG Oral Gel	SY	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12
1547593	Brace Relief 9 % Oral Gel	SY	d7e57d67-4234-44a9-bbd3-72e99cd5bdb3	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60306-115-05	60306011505	.3 mL in 1 TUBE (60306-115-05)	2005-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Brace Relief - InfaLab,Inc \| PhytogenX,Inc.	InfaLab,Inc \| PhytogenX,Inc.	2026-01-16	HUMAN OTC DRUG LABEL	12