Home NDC 52083-714 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 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-714-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-714-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-714-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-714-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-714-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-714-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-714-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-714-01 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 2026-12-31 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 20 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Mouth Sore Relief BENZOCAINE Walgreens 253d7ea2-e48e-c7d7-e063-6394a90ae001 2025-08-12 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE Gel SODIUM FLUORIDE Yangzhou Hongshengding Chemical Co.,Ltd. 897b0102-1c96-4699-908e-a7b7e26cd29f 2025-08-08 Warnings Exact identifier application number: M022 Meijer Enamel Guard POTASSIUM NITRATE, SODIUM FLUORIDE Meijer Distribution Inc 82bc95be-0a07-3f00-e053-2a91aa0a7438 2025-08-08 Warnings Exact identifier application number: M022 Topco Associates LLC Maximum Strength FLUORIDE Topco Associates LLC ac398ff0-0010-4e13-8b89-dc986fd7f974 2025-08-08 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE PLUS SOOTHING ALOE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 4ae4e88a-aaa5-4195-bedc-622fd5cd9394 2025-07-30 Warnings Exact identifier application number: M022 Aseptil Rojo PHENOL Menper Distributors, Inc. 62c96dc1-4698-43c1-8e6d-f4062dc5eea2 2025-07-22 Warnings Exact identifier application number: M022 Anestenka BENZOCAINE Menper Distributors, Inc 00a3f1bc-ddfe-47c6-8221-f48f91513503 2025-07-22 Warnings Exact identifier application number: M022 Cureforte Breath Reset MOUTH SPRAY STEEL CITY HEALTH PRIVATE LIMITED 38ddf1a7-29ab-cb8d-e063-6294a90ad34c 2025-07-21 Warnings Exact identifier application number: M022 SprinJene Natural Sensitivity and Gum POTASSIUM NITRATE Health and Natural Beauty USA Corp 3cb23e36-0e8c-4172-b4ae-859b58a2739f 2025-07-07 Warnings Exact identifier application number: M022 Normal Salt SODIUM CHLORIDE Twin Med LLC dc82ff0f-8600-373a-e053-2995a90a7505 2025-07-03 Warnings Exact identifier application number: M022 Sensodyne Pronamel Kids Berry Twist SODIUM FLUORIDE Haleon US Holdings LLC 69c07c36-b5e0-420b-ab29-7d1091386322 2025-07-03 Warnings Exact identifier application number: M022 DenTek Instant Pain Relief Maximum Strength BENZOCAINE DenTek Oral Care, Inc. ae92b76e-815a-4b4c-8128-bd045098caa5 2025-06-30 Warnings Exact identifier application number: M022 Sensodyne Clinical White Stain Protector POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC 99037e59-53d6-492c-8fce-67641fc8efdd 2025-06-25 Warnings Exact identifier application number: M022 Iolite-S BENZOCAINE Dharma Research, Inc. b3b68914-2adc-4f07-9521-0b18756be522 2025-06-14 Warnings Exact identifier application number: M022 Red Cross Toothache EUGENOL The Mentholatum Company 3537e599-65d9-48d6-8a46-d42312f71e84 2025-06-11 Warnings Exact identifier application number: M022 QUALITY CHOICE Sore Throat PHENOL CHAIN DRUG MARKETING ASSOCIATION c95ee086-f384-475d-ad0c-75518cb9d2fe 2025-06-10 Warnings Exact identifier application number: M022 Onral Oral Pain Reliever Mouthwash BENZOCAINE Syka Pharma Inc. 5dd8d933-6f32-4eaf-8eca-9365d7de55a2 2025-06-03 Warnings Exact identifier application number: M022 Orajel Rescue Relief Pen ORAL PAIN RELIEVER Church & Dwight Co., Inc. 2d68eec5-ae8a-9cdf-e063-6294a90a9799 2025-06-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 9e1f7462-a052-4db4-bc59-cce437b695d0 2025-05-20 Warnings Exact identifier application number: M022 Saline 1.5 FL OZ SALINE ALAINA HEALTHCARE PRIVATE LIMITED f1bdbb25-6943-4828-9ae0-7d9783c18b5f 2025-05-19 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