FDA.reportPublic FDA data

Benzocaine

Product NDC
67777-246
11-digit product format
677770246
Labeler code
67777
Product ID
67777-246_47be2d03-5dbc-7930-e063-6294a90a4395
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SWAB
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-20
Substance
ISOPROPYL ALCOHOL; BENZOCAINE
Active strength
60; 6 mg/100mL; mg/100mL
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67777-246-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67777-246-01bd6a592717d7…303034d00443…

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
Benzocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL60 mg/100mL
BENZOCAINE6 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
895749Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6161e94c-7849-466e-8da3-a6f1b085bdf9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-246-01Benzocaine2 mL in 1 PACKETSWAB222
67777-246-02Benzocaine3000 in 1 CASESWAB300022
67777-246-03Benzocaine10 in 1 BOXSWAB1022
67777-246-03Benzocaine2 mL in 1 PACKETSWAB222
67777-246-04Benzocaine480 in 1 CASESWAB48022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-246-01EA - Each67777-246682bfd84-7c49-4087-980a-40d199ea791e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5BENZOCAINE SWAB [DYNAREX CORPORATION]13
BENZOCAINEACTIVE MOIETYU3RSY48JW5BENZOCAINE SWAB [DYNAREX CORPORATION]13
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BENZOCAINE SWAB [DYNAREX CORPORATION]13
WATERINACTIVE INGREDIENT059QF0KO0RBENZOCAINE SWAB [DYNAREX CORPORATION]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-246BENZOCAINE SWAB [DYNAREX CORPORATION]21Current NDC, Legacy NDC, 5 package rows20240125_6161e94c-7849-466e-8da3-a6f1b085bdf9.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 48 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
application number: M003
GuardelleBENZALKONIUM CHLORIDESocial Medical Supply LLC8793e3be-7409-4f71-9397-abbeacd27cf82025-12-22WarningsExact identifier
application number: M003
CareALL First Aid Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCLNew World Imports, Inc69eef888-0044-485c-96a1-247ed12048582025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
application number: M003
Hand Sanitizer Vanilla CremeALCOHOL SOLUTIONNoshinku4692e68c-2bc8-83f8-e063-6294a90a84e42025-12-22WarningsExact identifier
application number: M003
Alcohol sanitizer wipesALCOHOL/PURIFIED WATERSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.ab9634bd-4226-2f73-e053-2995a90a802f2025-12-19WarningsExact identifier
application number: M003
Sanitizing WipesBENZALKONIUM CHLORIDEWipes LLC9e9a76d9-23e0-4d3a-9903-8bf7aba54aa32025-12-19WarningsExact identifier
application number: M003
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.afeccd10-c7e5-6193-e053-2995a90a9a5a2025-12-18WarningsExact identifier
application number: M003
Hand SanitizerBENZALKONIUM CHLORIDEDGH Pharma, Inc.ae4311f8-fc40-38a7-e053-2a95a90ae8292025-12-18WarningsExact identifier
application number: M003
AlcoholALCOHOLDynarex Corporation88c5dcbe-185f-4966-b98b-25d50299e8df2025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfc8cb10c-4973-c0bd-e053-6394a90a6fdb2025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf27cbf-9535-1356-e053-6394a90a03622025-12-18WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINETwinMed LLCfcf30b3a-c25b-7aaf-e053-6394a90affda2025-12-18WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ab5e8-029a-fe9d-e063-6294a90ac14d2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462ad5ba-253f-2a30-e063-6294a90a261d2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462af072-6709-546f-e063-6294a90aacc82025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b1d38-c7fa-992f-e063-6294a90ab78f2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Black RaspberryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b2d3f-67b0-c393-e063-6294a90a208a2025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Clementine BurstETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b36d0-0a1f-bda8-e063-6294a90a57922025-12-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895749benzocaine 6 % / isopropyl alcohol 60 % Medicated PadPSN6161e94c-7849-466e-8da3-a6f1b085bdf922
895749benzocaine 60 MG/ML / isopropyl alcohol 0.6 ML/ML Medicated PadSCD6161e94c-7849-466e-8da3-a6f1b085bdf922
895749benzocaine 6 % / isopropyl alcohol 60 % Medicated PadSY6161e94c-7849-466e-8da3-a6f1b085bdf922
895749benzocaine 6 % / isopropyl alcohol 60 % Topical SwabSY6161e94c-7849-466e-8da3-a6f1b085bdf922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-246-01677770246012 mL in 1 PACKET (67777-246-01) 2 ml2011-07-200000-00-00NoNoCurrent
67777-246-02677770246023000 PACKET in 1 CASE (67777-246-02) / 2 mL in 1 PACKET (67777-246-01) 3000 packet2011-07-200000-00-00NoNoCurrent
67777-246-036777702460310 in 1 BOXHistorical
67777-246-0467777024604480 BOX in 1 CASE (67777-246-04) / 10 PACKET in 1 BOX (67777-246-03) / 2 mL in 1 PACKET480 box2011-07-20NoNoCurrent