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 67 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Overtime	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Physicians Science & Nature Inc.	25fec070-8587-42d1-ba6f-1a9c150acc98	2025-11-10	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Physicians Science & Nature Inc.	05742cd5-ece2-4007-bdf0-46b76d23df74	2025-11-10	Warnings	Exact identifier application number: M017
Anal Blu	DESENSITIZER	Novelties by Nasswalk, Inc.	03b9555b-c3ff-4baa-e063-6394a90afb2c	2025-11-10	Warnings	Exact identifier application number: M017
Stallion	DELAY CREME	Novelties by Nasswalk, Inc.	0261ec88-8fe4-d5f8-e063-6294a90ab3d4	2025-11-10	Warnings	Exact identifier application number: M017
ANAL-ESE	DESENSITIZER	Novelties by Nasswalk, Inc.	03b89eed-b433-a263-e063-6294a90a675b	2025-11-10	Warnings	Exact identifier application number: M017
Instant Erection	ULTIMATE ERECTION ENHANCER	Novelties by Nasswalk, Inc.	03a444f9-7052-0c38-e063-6294a90a4e56	2025-11-10	Warnings	Exact identifier application number: M017
STA-HARD	DESENSITIZING LUBRICANT	Novelties by Nasswalk, Inc.	02ef794b-8e70-5c26-e063-6294a90a28d1	2025-11-10	Warnings	Exact identifier application number: M017
ANAL-ESE	DESENSITIZER	Novelties by Nasswalk, Inc.	03a4a7ce-4cff-a608-e063-6294a90ad65d	2025-11-10	Warnings	Exact identifier application number: M017
FOOTSPA PEDI	ALCOHOL	CHEMCO CORPORATION	04de4392-74f6-7df8-e063-6294a90ae3b1	2025-11-08	Warnings	Exact identifier application number: M017
Johnson and Johnson All Purpose First Aid Kit	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	5cdb47c5-7951-4279-8a05-0a3199d3dd45	2025-11-06	Warnings	Exact identifier application number: M017
Johnson and Johnson First Aid Travel Ready 80 CT	ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f388f105-48ba-4616-e053-2a95a90a0049	2025-11-06	Warnings	Exact identifier application number: M017
Johnson and Johnson First Aid All Purpose 160 CT	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f3933330-2550-4a88-e053-2a95a90a3997	2025-11-06	Warnings	Exact identifier application number: M017
Foot and Leg Pain Relief	LIDOCAINE	Premier Brands of America Inc.	42f23e2f-11c6-da49-e063-6294a90ac720	2025-11-06	Warnings	Exact identifier application number: M017
HEALING TREE CALMING ANTI-ITCH	HYDROCORTISONE	Renu Laboratories, LLC	fc8bcde9-26e8-a35f-e053-6394a90a3300	2025-11-06	Warnings	Exact identifier application number: M017
Calamine Plus	CALAMINE PLUS PRAMOXINE HCL	Chain Drug Marketing Association Inc	1a3f8819-58cf-8923-e063-6394a90a37af	2025-11-06	Warnings	Exact identifier application number: M017
Extra Strength Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	Chain Drug Marketing Association Inc	1a2997bc-7741-e658-e063-6394a90af6fd	2025-11-06	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY	Topco Associates LLC	8026c7dd-eb7b-ebea-e053-2991aa0a1b0f	2025-11-06	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	Walgreen Company	6057b4ff-6adc-4688-893c-62d237d7d1ae	2025-11-06	Warnings	Exact identifier application number: M017
BANPINGHUA Glucosamine Chondroitin Patch	PEPPERMINT, CAMPHOR, BORNEOL	Henan Lijitang Medical Technology Co., Ltd.	42f8c2ae-50a2-2358-e063-6394a90a5979	2025-11-06	Warnings	Exact identifier application number: M017
PAINGEL	CAMPHOR, MENTHOL	NACOR BUSINESS GROUP LLC	42fa2397-b61a-3b16-e063-6294a90a5fed	2025-11-06	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