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 33 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COOL RELIEF LEMON FROST ORAL ANESTHETIC MENTHOL Ricola Ag 908f5ce5-94a4-4c35-ae7a-b308ea37fa08 2024-12-05 Warnings Exact identifier application number: M022 ORGANIC PEPPERMINT HERB THROAT DROPS MENTHOL Ricola Ag a6657ecf-e74a-4912-a68c-73abc456f9e2 2024-12-05 Warnings Exact identifier application number: M022 NATURAL LEMON MINT HERB THROAT DROPS MENTHOL Ricola Ag 67373cf1-e8c3-4db2-98e1-c88d25a76209 2024-12-05 Warnings Exact identifier application number: M022 Natural Cherry Honey Herb Throat Drops MENTHOL Ricola Ag 586b2a46-2673-4f27-a62a-2d48a9b520ab 2024-12-05 Warnings Exact identifier application number: M022 BERRY MEDLEY THROAT DROPS MENTHOL Ricola Ag a2bdd035-4678-4cff-b24f-8e2f06acad96 2024-12-05 Warnings Exact identifier application number: M022 Orajel Toothache Rinse BENZYL ALCOHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 41709710-5392-3119-e054-00144ff88e88 2024-11-27 Warnings Exact identifier application number: M022 Orajel Antiseptic Alcohol-Free Mouth Sore Rinse HYDROGEN PEROXIDE, MENTHOL Church & Dwight Co., Inc. 99d47d6a-fa2e-d5ee-e053-2995a90aa11d 2024-11-27 Warnings Exact identifier application number: M022 Orajel 2x Gum Pain Alcohol-Free MENTHOL AND HYDROGEN PEROXIDE Church & Dwight Co., Inc. adf37010-922c-4441-93d6-1e1a95025e90 2024-11-27 Warnings Exact identifier application number: M022 Maximum Strength Cold Sore Treatment CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM Meijer Distribution Inc 9220772c-b3b7-4855-e053-2a95a90a94f6 2024-11-27 Warnings Exact identifier application number: M022 Peroxyl Mouth Sore Mild Mint HYDROGEN PEROXIDE Colgate Oral Pharmaceuticals Inc. b1e1b7c9-dea7-4d64-b6a8-5343f4176359 2024-11-25 Warnings Exact identifier application number: M022 NICE SORE THROAT Spearmint PHENOL Leosons Overseas Corp 5fc68f04-ec15-11c0-e053-2a91aa0a1952 2024-11-20 Warnings Exact identifier application number: M022 TANAC Oral Pain Reliever BENZOCAINE Leosons Overseas Corp 81cc61fa-31a7-2214-e053-2a91aa0ae46a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Honey Lemon PHENOL Leosons Overseas Corp 601aea98-e6ab-de6f-e053-2a91aa0a824a 2024-11-15 Warnings Exact identifier application number: M022 NICE SORE THROAT Cherry PHENOL Leosons Overseas Corp 5f21694c-d1c9-0e64-e053-2a91aa0a0ff0 2024-11-15 Warnings Exact identifier application number: M022 Sore Throat PHENOL Safeway, Inc. f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d 2024-11-14 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry PHENOL Best Choice (Valu Merchandisers Company) c0a47d59-3e15-453d-97a7-d626e8650862 2024-11-14 Warnings Exact identifier application number: M022 Listerine Gum Therapy Glacier Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Kenvue Brands LLC ed6889b6-58db-41cf-e053-2a95a90a7de2 2024-11-11 Warnings Exact identifier application number: M022 Listerine FreshBurst Antiseptic EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8 2024-11-11 Warnings Exact identifier application number: M022 Listerine Ultraclean Antiseptic Cool Mint EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC dd3729c2-fd05-4db0-a542-487bb0f9001f 2024-11-11 Warnings Exact identifier application number: M022 Listerine Cool Mint Antiseptic EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Kenvue Brands LLC 9e97e4f8-80c2-44e0-862c-0dfca392a436 2024-11-11 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