FDA.reportPublic FDA data

Gumsol

Product NDC
52083-714
11-digit product format
520830714
Labeler code
52083
Product ID
52083-714_df716e50-f0a6-4548-b354-29dd8c29924c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Zinc Chloride
Dosage form
SPRAY
Route
ORAL
Labeler
Kramer Novis
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-28
Substance
BENZOCAINE; ZINC CHLORIDE
Active strength
1.5; .03 g/30mL; g/30mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gumsol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE1.5 g/30mL
ZINC CHLORIDE.03 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, 86Q357L16B
Rxcui485558

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
52083-714-012025-11-18C16284748780-12cef2736-9d02-d83d-e063-dadaa90ab31fGUMSOL
52083-714-012025-01-30C16284748780-12cef2736-9d02-d83d-e063-dadaa90ab31fGUMSOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-714-01Gumsol30 mL in 1 BOTTLESPRAY303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-714-01ML - Milliliter52083-714a3d40f00-3276-485a-b753-8b0f10a9ed8f12014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-714GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS]2Current NDC, Legacy NDC, 1 package rows20181211_3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485558benzocaine 5 % / zinc chloride 0.1 % Mucosal SprayPSN3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf3
485558benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucosal SpraySCD3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf3
485558benzocaine 5 % / zinc chloride 0.1 % Mucosal SpraySY3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-714-015208307140130 mL in 1 BOTTLE (52083-714-01) 30 ml2014-02-280000-00-00NoNoCurrent