FDA.reportPublic FDA data

Gumsol

Product NDC
52083-713
Requested package NDC
52083-713-01
11-digit product format
520830713
Labeler code
52083
Product ID
52083-713_371d4ba3-420a-412c-ad8a-d88aa68c0d5b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Zinc Chloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kramer Novis
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-28
Marketing end
0000-00-00
Substance
BENZOCAINE; ZINC CHLORIDE
Active strength
2 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage52083-71352083-713-01IInactivated by FDA2026-10-12

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 · 15 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…

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-713-012023-01-30C16284748780-1f386c64a-3ec2-0266-e053-dadaa90a7c1aGUMSOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-713-01Gumsol30 mL in 1 BOTTLESOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-713-01ML - Milliliter52083-713f1176c0e-c5ff-4c4b-a337-ffc7dd17be6812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
ZINC CHLORIDEACTIVE INGREDIENT86Q357L16BGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
ZINC CATIONACTIVE MOIETY13S1S8SF37GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1
WATERINACTIVE INGREDIENT059QF0KO0RGUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-713GUMSOL (BENZOCAINE, ZINC CHLORIDE) SOLUTION [KRAMER NOVIS]2Legacy NDC, 1 package rows20181211_3ef75f3c-cc00-4b39-9249-161da76bb9a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485560benzocaine 5 % / zinc chloride 0.1 % Mucous Membrane Topical SolutionPSN3ef75f3c-cc00-4b39-9249-161da76bb9a72
485560benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucous Membrane Topical SolutionSCD3ef75f3c-cc00-4b39-9249-161da76bb9a72
485560benzocaine 5 % / zinc chloride 0.1 % Mucous Membrane Topical SolutionSY3ef75f3c-cc00-4b39-9249-161da76bb9a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-713-015208307130130 mL in 1 BOTTLE (52083-713-01) 30 ml2014-02-280000-00-00NoNoCurrent