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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Meijer, Inc.	c9c17224-9304-403a-b6a1-9c8bd94e3d94	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M022
AQUAFRESH CAVITY PROTECTION	SODIUM FLUORIDE	Haleon US Holdings LLC	5484999c-8e6f-430d-99a5-6893a2489467	2026-02-16	Warnings	Exact identifier application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTION	SODIUM FLUORIDE	Haleon US Holdings LLC	aaff19d9-4ba5-462a-893b-7220feb25d6c	2026-02-16	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Walgreen Co.	55807b18-42ed-45a7-845e-fcf7f5d70d04	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: m022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Walgreen Co.	33223589-4ff4-4e4e-96da-6fa2e4d0f187	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M022
PERIOSCIENCES SENSITIVE AO Pro	POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE	PERIOSCIENCES LLC	acca8964-b575-468c-8b40-514dfbf50778	2026-02-09	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	Retail Business Services, LLC	d46546d0-c6df-431a-8ab0-bc5013c084d7	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	e19228e9-6f87-456e-a222-f979a234d589	2026-02-06	Warnings	Exact identifier application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	49d28991-b68f-ba16-e063-6394a90a0b13	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Strawberry Lemonade	PECTIN	Primrose Candy Co.	49e2b303-1018-cd13-e063-6394a90ae300	2026-02-02	Warnings	Exact identifier application number: M022
Sootheez Berry Lemonade	PECTIN	Primrose Candy Co.	49cee56f-c45f-6c79-e063-6294a90a5f8f	2026-02-01	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	Rite Aid Corporation	294418aa-640d-42be-ad07-de31da7a7ccc	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain Reliever	MEDICATED TOOTH AND GUM PAIN RELIEVER	Kungpo Health Care & Herbal Center Inc	aa61ce6f-8336-4071-93b8-549fd22d1ae0	2026-01-22	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	866067b9-3dce-492d-ae99-1b807ecd56ff	2026-01-22	Warnings	Exact identifier application number: M022
Family Wellness Pain Relief	BENZOCAINE 20%	FAMILY DOLLAR (Family Wellness)	92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea	2026-01-21	Warnings	Exact identifier application number: M022
Crest Pro-Health All Day Clean Breath	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	48eaca4c-19c2-2dd2-e063-6394a90a3e08	2026-01-21	Warnings	Exact identifier application number: M022
Betadine Gargle	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	5f0a3377-1398-2603-c632-f0d214bb88ec	2026-01-21	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Universal Distribution Center LLC	e276ba37-46fb-4ed9-9ee1-c08a2a89704a	2026-01-20	Warnings	Exact identifier application number: M022
Equate Orasol	20% BENZOCAINE	WAL-MART STORES INC.	08404780-8252-4484-b1c3-8970803f74f8	2026-01-19	Warnings	Exact identifier application number: M022
Equate Healthy Mouth	CPC 0.05% ANTIPLAQUE/ANTI-GINGIVITIS	Walmart, Inc.	1cc1f6fd-67d4-b314-e063-6294a90ab995	2026-01-19	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