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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S.T.37	HEXYLRESORCINOL	NUMARK BRANDS, INC	7d7acca2-aa8a-5272-e813-faab039cc798	2025-12-15	Warnings	Exact identifier application number: M022
Esunix Oral Bacteriostatic Gel	CETYLPYRIDINIUM CHLORIDE	Xiling (Zhenjiang) Medical Technology Co., Ltd.	3f4ee467-8142-8cb7-e063-6394a90aa7f7	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999851ac-925c-7d1f-e053-2a95a90a240b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For Toothache and Gum	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99a2b061-0875-59a4-e053-2995a90ab373	2025-12-12	Warnings	Exact identifier application number: M022
Orajel Antiseptic Rinse For All Mouth Sores	HYDROGEN PEROXIDE AND MENTHOL	Church & Dwight Co., Inc.	06188d36-0d60-6ae6-e054-00144ff8d46c	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 3X Medicated For All Mouth Sores	BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	99b589ac-9833-fb60-e053-2995a90a0935	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated For Toothache and Gum, Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999aa7b9-bf9e-9285-e053-2a95a90a345b	2025-12-12	Warnings	Exact identifier application number: M022
Orajel 4X Medicated PM For Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	999cff2b-c23e-5abe-e053-2a95a90a7569	2025-12-12	Warnings	Exact identifier application number: M022
Benzoin Compound Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	a893a232-2ea8-4e0d-8cbf-7f5040b3be2e	2025-12-11	Warnings	Exact identifier application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	456d45e8-bf6d-31c4-e063-6394a90a5c00	2025-12-10	Warnings	Exact identifier application number: M022
Oral pain relief	BENZOCAINE	ALAINA HEALTHCARE PRIVATE LIMITED	d98c1b2f-fe75-4d52-b082-1abb7628c59e	2025-12-09	Warnings	Exact identifier application number: M022
HEB Sensitive Extra Whitening Twin	SODIUM FLUORIDE	HEB	41d5ae3e-51c1-263b-e063-6394a90a3312	2025-12-08	Warnings	Exact identifier application number: M022
CankerMelts	BENZOCAINE	Quest Products, LLC	070dae82-14c2-66d2-e063-6394a90ab259	2025-12-04	Warnings	Exact identifier application number: M022
Sore Throat ReadyInCase	PHENOL	P & L Development, LLC	2fb3d17e-8ca3-4edb-8b82-4b484f42616e	2025-12-03	Warnings	Exact identifier application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	44f2b66a-26ae-1044-e063-6394a90a9ab6	2025-12-02	Warnings	Exact identifier application number: M022
Sensodyne Fresh Clean	STANNOUS FLUORIDE	Haleon US Holdings LLC	2d433ac1-3ddf-a2f4-e063-6394a90a91f8	2025-12-01	Warnings	Exact identifier application number: M022
Walgreens Saline	NASAL	WALGREEN COMPANY	147e45c8-1e71-4c06-89f1-42e9f9683366	2025-12-01	Warnings	Exact identifier application number: M022
EELHOE Probiotic Bright White Fresh	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	425cec0e-aa74-5341-e063-6294a90ac86b	2025-11-27	Warnings	Exact identifier application number: M022
EELHOE 5 Days Tooth Powder	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	42f98b14-d1d5-4af8-e063-6294a90a8f67	2025-11-27	Warnings	Exact identifier application number: M022
JAYSUING Colour Corrector	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	425d9c23-a692-3c62-e063-6294a90a9404	2025-11-27	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