Home NDC 52083-714-01 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 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 1.5 g/30mL ZINC CHLORIDE .03 g/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-714-01 Gumsol 30 mL in 1 BOTTLE SPRAY 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 ZINC CHLORIDE ACTIVE INGREDIENT 86Q357L16B GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 CETYLPYRIDINIUM CHLORIDE INACTIVE INGREDIENT D9OM4SK49P GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-714 GUMSOL (BENZOCAINE, ZINC CHLORIDE) SPRAY [KRAMER NOVIS] 2 Current NDC, Legacy NDC, 1 package rows 20181211_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 34 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orajel 2X Medicated Gel ORAL PAIN RELIEVER Church & Dwight Co., Inc. 262be295-4eaf-3136-e063-6294a90a7dcc 2024-11-05 Warnings Exact identifier application number: M022 BIOTENE Fresh Mint Original SODIUM FLUORIDE Haleon US Holdings LLC 1101c17f-c848-4cd5-a7cd-679b59dbe1bf 2024-11-05 Warnings Exact identifier application number: M022 biotene SODIUM MONOFLUOROPHOSPHATE Haleon US Holdings LLC a47a6502-efb2-4072-9562-cbe293531c2b 2024-11-04 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Cherry SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited a0e145c8-6b08-40be-ae4f-5678c4a78b1e 2024-10-30 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33b-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33a-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043a3cb4-f560-0ffd-e063-6394a90a2ff6 2024-10-29 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Mint SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited be57ca56-834f-4170-a407-f193484d8b0a 2024-10-29 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint SODIUM FLUORIDE Haleon US Holdings LLC 817c0dad-d109-428e-adb5-3354604acc94 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 1f3d68f6-afd6-42e7-b3e5-210228c8e7de 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals LLC 0dd15227-6603-42ac-9a5f-f2dc49e0382a 2024-10-28 Warnings, Adverse reactions Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 0605d5d6-82bd-415e-b5cb-e273f934a4a7 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC f70fa3fc-cd65-4a80-9efd-129e98fd3998 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Menthol PHENOL Chain Drug Consortium af661ef0-cdc3-4146-8ae5-59795aa49650 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry Flavor PHENOL Chain Drug Consortium a9cf9829-4b70-44fa-9719-240b65c06724 2024-10-28 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE PHARMACY VALUE ALLIANCE, LLC 85ae80c1-2bc2-4c90-9559-63510d03e739 2024-10-28 Warnings Exact identifier application number: M022 Chloraspetic MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. 2b1808b2-2574-4ab8-a762-5733251848ce 2024-10-25 Warnings Exact identifier application number: M022 Chloraseptic Warming Sore Throat PHENOL Prestige Brands Holdings, Inc. a197fab2-70ce-4a6c-9add-29d7368a75c5 2024-10-25 Warnings Exact identifier application number: M022 Gly-Oxide CARBAMIDE PEROXIDE Medtech Products Inc. 086a0b82-e947-41c9-89e7-ba06483960c9 2024-10-25 Warnings Exact identifier application number: M022 CHLORASEPTIC MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. d500f423-b9f2-4d98-8f2a-8bab7c05737c 2024-10-25 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52083-714-01 52083071401 30 mL in 1 BOTTLE (52083-714-01) 30 ml 2014-02-28 0000-00-00 No No Current