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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52083-714-01	2025-11-18	C162847	48780-1	2cef2736-9d02-d83d-e063-dadaa90ab31f	GUMSOL
52083-714-01	2025-01-30	C162847	48780-1	2cef2736-9d02-d83d-e063-dadaa90ab31f	GUMSOL

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52083-714-01	ML - Milliliter	52083-714	a3d40f00-3276-485a-b753-8b0f10a9ed8f	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 4 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GingiCaine Gel, Pina Colada	GINGICAINE GEL, PINA COLADA FLAVOR	Gingi-Pak a Division of the Belport	6284e1fe-be33-69bf-e053-2991aa0a90ab	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Chocolate Mint	GINGICAINE GEL, CHOCOLATE MINT FLAVOR	Gingi-Pak a Division of the Belport	6285c4f2-c139-49a9-e053-2991aa0a2b03	2026-06-29	Warnings	Exact identifier application number: M022
UltraCare Anesthetic Gel	BENZOCAINE	The Bellport Company, Inc. dba Gingi-Pak	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2026-06-26	Warnings	Exact identifier application number: M022
GingiCaine Gel	GINGICAINE GEL BANANA FLAVOR	Gingi-Pak a Division of the Belport	62857d06-a829-4efa-e053-2991aa0a6d15	2026-06-25	Warnings	Exact identifier application number: M022
GingiCaine Gel, Cotton Candy Flavor	GINGICAINE GEL, COTTON CANDY FLAVOR	Gingi-Pak a Division of the Belport	628515a5-175f-ac2c-e053-2991aa0a19ce	2026-06-25	Warnings	Exact identifier application number: M022
Perox-A-Mint Solution	HYDROGEN PEROXIDE	Sage Products, LLC	50823ff5-ad08-4449-bc4a-9a8ae25ec0d5	2026-06-24	Warnings	Exact identifier application number: M022
Antiseptic Oral Rinse	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	efff8bae-154d-46bc-8dd4-716800425663	2026-06-24		Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	8c6ac499-9bd2-4ea5-9f26-df7947bff4a6	2026-06-22	Warnings	Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	dcc37403-0192-4658-bb7a-059273ce0047	2026-06-22	Warnings	Exact identifier application number: M022
Toothache	POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE	Guchutang Biotechnology (Longyan) Co., Ltd	54ad2ceb-272f-e5ba-e063-6394a90aec5f	2026-06-20	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Delon Laboratories (1990) Ltd	d4aa09bf-8207-47dd-bc42-01e660da9438	2026-06-16	Warnings	Exact identifier application number: M022
TideFresh MOUTH SORE AND TOOTHACHE	BENZOCAINE 20% MOUTH SORE AND TOOTHACHE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	541e1814-c00e-efdf-e063-6394a90a41a1	2026-06-13	Warnings	Exact identifier application number: M022
Chloraseptic Sore Throat Max	PHENOL AND GLYCERIN	Prestige Brands Holdings, Inc.	882c940c-b3c3-4aa4-8d64-e4260f066ff4	2026-06-08	Warnings	Exact identifier application number: M022
Orazen	SODIUM MONOFLUOROPHOSPHATE	Orazen Inc	fa5b6bd8-443f-79e7-e053-6394a90a5513	2026-06-03	Warnings	Exact identifier application number: M022
Fishermans Friend Mixed Berry	MENTHOL	Lofthouse of Fleetwood	53391c4d-ee2d-ade3-e063-6394a90ac77d	2026-06-01	Warnings	Exact identifier application number: M022
Orajel Medicated for Toothache and Gum, Liquid	BENZOCAINE AND MENTHOL	Church & Dwight Co., Inc.	ac3d605d-241d-1a6f-e053-2a95a90ae391	2026-06-01	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	6140d487-d87c-4954-9247-83492bcc5738	2026-05-27	Warnings	Exact identifier application number: M022
Dolodent Maximum Strength	BENZOCAINE	Pharmadel LLC	351ecc2b-cc1a-2bbf-e063-6394a90a5c14	2026-05-26	Warnings	Exact identifier application number: M022
MOUTH ULCER	PANTHENOL	Guangzhou Shengli Shidai Cosmetics Co., Ltd.	5264f81c-bffe-4f6d-e063-6394a90ae3bf	2026-05-22	Warnings	Exact identifier application number: M022
Sensitivity Relief Fluoride Free	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	c23b2a83-ebc3-4bcf-a216-7693944dcfa0	2026-05-22	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
86Q357L16B	ZINC CHLORIDE	7646-85-7	ZINC CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485558	benzocaine 5 % / zinc chloride 0.1 % Mucosal Spray	PSN	3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf	3
485558	benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucosal Spray	SCD	3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf	3
485558	benzocaine 5 % / zinc chloride 0.1 % Mucosal Spray	SY	3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf	3

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