FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct60306-115IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage60306-11560306-115-05IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
BENZOCAINE9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1547591Internal RxNorm lookup
1547593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7e57d67-4234-44a9-bbd3-72e99cd5bdb3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60306-115-052022-04-11C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-052019-12-13C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3
60306-115-052019-11-27C16284748780-19855e2a2-3c21-60a7-e053-dbdaa90a05bdd7e57d67-4234-44a9-bbd3-72e99cd5bdb3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60306-115-05Brace Relief0.3 mL in 1 TUBEGEL0.312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
BenzocaineACTIVE MOIETYU3RSY48JW5BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Clove OilINACTIVE INGREDIENT578389D6D0BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MentholINACTIVE INGREDIENTL7T10EIP3ABRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
MyrrhINACTIVE INGREDIENTJC71GJ1F3LBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Peppermint OilINACTIVE INGREDIENTAV092KU4JHBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
PhenolINACTIVE INGREDIENT339NCG44TVBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHBRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60306-115BRACE RELIEF (BENZOCAINE) GEL [INFALAB,INC]11Current NDC, Legacy NDC, 1 package rows20241010_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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEFred's, Inc.41ee7a50-d36b-4214-b6f8-44f47ab44a842025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATELidl US, LLC98389314-c2cf-4510-ab3d-41c4c47200192025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN BPublix Super Markets Inc72bdb96c-af93-4a9b-93d9-81a94b6ff7562025-07-15WarningsExact identifier
application number: M004
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETopco Associates LLC55a8a52c-4d03-417d-9283-406f6879bcb52025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
application number: M004
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
application number: M004
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
application number: M004
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
application number: M004
Publix antibiotic plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEPublix Super Markets Incd0193bf1-a257-490e-a058-5e6a514981da2025-07-15WarningsExact identifier
application number: M004
Live Better Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEThe Great Atlantic & Pacific Tea Company7d3435ad-7d73-4db6-8019-3040b3dadfa92025-07-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWal-Mart Stores, Inc.f5199476-1ce2-4a82-9685-40d78b7a89352025-07-14WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC38414fff-8dad-44d0-9dfa-f89a63ef9b442025-07-14WarningsExact identifier
application number: M004
sunmark double antibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEStrategic Sourcing Services LLC2868de5c-4894-45ee-9647-9acd3bde7cfc2025-07-14WarningsExact identifier
application number: M004
Live Better Bacitracin ZincBACITRACIN ZINCThe Great Atlantic & Pacific Tea Company6915940c-2eae-445c-ba58-e39d221e9d3d2025-07-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSTRATEGIC SOURCING SERVICES LLC4594948d-1f25-4d3c-a615-9e6edda05a102025-07-11WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Bacitracin ZincBACITRACIN ZINCAmerisourceBergen3fb302b5-7273-412c-a2ba-b76183e3f1792025-07-11WarningsExact identifier
application number: M004
TopCare Bacitracin ZincBACITRACIN ZINCTopco Associates LLC5b59e26d-cc25-49a6-ac8b-f79398e18f2d2025-07-07WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1547591benzocaine 9 % Oral GelPSNd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 9 % Oral GelPSNd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593benzocaine 0.09 MG/MG Oral Gel [Brace Relief]SBDd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547591benzocaine 0.09 MG/MG Oral GelSCDd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547591benzocaine 9 % Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 0.09 MG/MG Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312
1547593Brace Relief 9 % Oral GelSYd7e57d67-4234-44a9-bbd3-72e99cd5bdb312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60306-115-0560306011505.3 mL in 1 TUBE (60306-115-05) 2005-01-030000-00-00NoNoCurrent