FDA.reportPublic FDA data

Gumsol

Product NDC
52083-714
Requested package NDC
52083-714-01
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

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 · 8 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Gumsol
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
86Q357L16BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bfAvailable on FDA.report

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

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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

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