FDA.reportPublic FDA data

Mark 3

Product NDC
61509-104
Requested package NDC
61509-104-32
11-digit product format
615090104
Labeler code
61509
Product ID
61509-104_bd33dee8-f8c0-c670-e053-2995a90af3f8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL; ORAL
Labeler
Cargus International, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-03-03
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
6 g/32g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61509-10461509-104-32IInactivated by FDA2026-10-15

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
61509-104-322023-01-30C16284748780-19855e2a2-3fc0-60a7-e053-dbdaa90a05bdd65bc785-aafc-4f4c-860b-890fb59b552e
61509-104-322021-03-23C16284748780-19855e2a2-3fc0-60a7-e053-dbdaa90a05bdd65bc785-aafc-4f4c-860b-890fb59b552e
61509-104-322019-11-27C16284748780-19855e2a2-3fc0-60a7-e053-dbdaa90a05bdd65bc785-aafc-4f4c-860b-890fb59b552e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61509-104-32Mark 332 g in 1 BOTTLEGEL322

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EMARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61509-104MARK 3 (BENZOCAINE) GEL [CARGUS INTERNATIONAL, INC.]2Legacy NDC, 1 package rows20210324_d65bc785-aafc-4f4c-860b-890fb59b552e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNd65bc785-aafc-4f4c-860b-890fb59b552e2
238910benzocaine 0.2 MG/MG Oral GelSCDd65bc785-aafc-4f4c-860b-890fb59b552e2
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYd65bc785-aafc-4f4c-860b-890fb59b552e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61509-104-326150901043232 g in 1 BOTTLE (61509-104-32) 32 g2021-03-230000-00-00NoNoCurrent