4x Medicated Toothache and Gum Cream

Product NDC: 0363-0607
11-digit product format: 003630607
Labeler code: 0363
Product ID: 0363-0607_43956f7c-4305-e136-e063-6394a90a61d0
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: CREAM
Route: ORAL
Labeler: Walgreens
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-02
Substance: BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength: 20; .13; .15; .26 g/100g; g/100g; g/100g; g/100g
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0363-0607		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0607	0363-0607-79	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-0607	0363-0607-19	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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: 4x Medicated Toothache and Gum Cream
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g
BENZALKONIUM CHLORIDE	.13 g/100g
ZINC CHLORIDE	.15 g/100g
MENTHOL, UNSPECIFIED FORM	.26 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
F5UM2KM3W7	Internal UNII lookup
86Q357L16B	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2370903	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
a71c2092-4ece-b82e-e053-2995a90ac933	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0607-19	4x Medicated Toothache and Gum Cream	1 in 1 CARTON	CREAM	1	10
0363-0607-19	4x Medicated Toothache and Gum Cream	14 g in 1 TUBE	CREAM	14	10
0363-0607-79	4x Medicated Toothache and Gum Cream	1 in 1 CARTON	CREAM	1	10
0363-0607-79	4x Medicated Toothache and Gum Cream	9.4 g in 1 TUBE	CREAM	9.4	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0607	4X MEDICATED TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [WALGREENS]	8	Current NDC, Legacy NDC, 4 package rows	20250123_a71c2092-4ece-b82e-e053-2995a90ac933.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 101 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebbc0f-9888-b812-e053-2a95a90a5d3d	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Arthritis Aches and Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec7255-bb36-41cd-e053-2a95a90aeac4	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Back and Neck Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec8fc9-c401-5f23-e053-2995a90acb1c	2025-01-28	Warnings	Exact identifier application number: M017
Muscle Therapy	METHYL SALICYLATE, CAMPHOR	Everlaan Organics Inc	0890a683-9a66-fdbd-e063-6294a90ae526	2025-01-27	Warnings	Exact identifier application number: M017
Joint Therapy	CAMPHOR	Everlaan Organics Inc	08904b77-d6db-8b82-e063-6394a90ace4f	2025-01-27	Warnings	Exact identifier application number: M017
Warrior Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	013f48b9-913f-b283-e063-6394a90abd73	2025-01-27	Warnings	Exact identifier application number: M017
DCH Cool and Heat	MENTHOL 16%	Derma Care Research Labs, LLC	ff323282-612c-eaf8-e053-6394a90ab779	2025-01-27	Warnings	Exact identifier application number: M017
Gerigentle	HYDROCORTISONE	GERI-GENTLE CORPORATION	0adfa2f0-9758-5c54-e063-6294a90a461f	2025-01-25	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative Inc.	42f1abeb-f6d7-01c3-e054-00144ff88e88	2025-01-23	Warnings	Exact identifier application number: M017
FORTHiQ Pain Relief Lidocaine Patch	PAIN RELIEF LIDOCAINE PATCH	Henan Enokon Medical Instrument Co., Ltd.	2c593420-5788-3422-e063-6394a90a1890	2025-01-22	Warnings	Exact identifier application number: M017
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1c3e5068-dd61-ebdb-e063-6294a90a97cc	2025-01-20	Warnings	Exact identifier application number: M017
PROHEAL BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	2025-01-19	Warnings	Exact identifier application number: M017
HERSTAT PLUS Cold Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e20ea714-663d-c4ac-e053-2a95a90a5ecc	2025-01-18	Warnings	Exact identifier application number: M017
Pain Relief Medicated	CAMPHOR MENTHOL METHYL SALICYTATE	RITE AID CORPORATION	60895211-69f3-478b-a33f-1c2071f62950	2025-01-16	Warnings	Exact identifier application number: M017
Elgin Pain Relief	MENTHOL	Eco-Logics, Inc.	70eda21e-e566-42f4-9a49-b0d3ad000652	2025-01-16	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone Topical	HYDROCORTISONE	WalMart	1f64555d-f77e-4a83-b222-fdb3ed7d8853	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone	HYDROCORTISONE	WalMart	f5c32b4a-1159-4b7a-b8ac-256d53020dc2	2025-01-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
86Q357L16B	ZINC CHLORIDE	7646-85-7	ZINC CHLORIDE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2370903	benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream	PSN	a71c2092-4ece-b82e-e053-2995a90ac933	10
2370903	benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral Cream	SCD	a71c2092-4ece-b82e-e053-2995a90ac933	10
2370903	benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream	SY	a71c2092-4ece-b82e-e053-2995a90ac933	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0607-19	00363060719	1 TUBE in 1 CARTON (0363-0607-19) / 14 g in 1 TUBE	1 tube	2024-02-16		No	No	Current
0363-0607-79	00363060779	1 TUBE in 1 CARTON (0363-0607-79) / 9.4 g in 1 TUBE	1 tube	2020-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820627 WLG 4x Med Cream (80-15601)	Walgreens \| Lornamead Products	2025-11-14	HUMAN OTC DRUG LABEL	10