4X Medicated Severe Toothache and Gum Cream

Product NDC: 11822-0614
11-digit product format: 118220614
Labeler code: 11822
Product ID: 11822-0614_437ff1ad-5461-e55c-e063-6394a90a258b
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: CREAM
Route: ORAL
Labeler: Rite Aid
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-06
Marketing end: 2027-01-01
Substance: BENZOCAINE; MENTHOL; ZINC CHLORIDE; BENZALKONIUM CHLORIDE
Active strength: 20; .26; .15; .13 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
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 · 2 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	11822-0614		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	11822-0614	11822-0614-9	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 Severe Toothache and Gum Cream

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g
MENTHOL	.26 g/100g
ZINC CHLORIDE	.15 g/100g
BENZALKONIUM CHLORIDE	.13 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
L7T10EIP3A	Internal UNII lookup
86Q357L16B	Internal UNII lookup
F5UM2KM3W7	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
996fdbeb-1fe3-77b6-e053-2995a90a25c7	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	Strength	SPL version
11822-0614-9	4X Medicated Severe Toothache and Gum Cream	1 in 1 CARTON	CREAM	1		14
11822-0614-9	4X Medicated Severe Toothache and Gum Cream	9.4 g in 1 TUBE	CREAM	9.4		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0614	4X MEDICATED SEVERE TOOTHACHE AND GUM CREAM (BENZOCAINE) CREAM [RITE AID]	12	Current NDC, Legacy NDC, 2 package rows	20250121_996fdbeb-1fe3-77b6-e053-2995a90a25c7.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 37 of 39 · 774 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE PRONAMEL Daily Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	edffce4d-108b-4ffd-9adf-e12cb42ffddd	2024-01-24	Warnings	Exact identifier application number: M022
Peppermint Twist	FLUORIDE	Caldwell Health LLC	4b28cdd1-0dba-42f5-a9e8-06d9e75b2396	2024-01-17	Warnings	Exact identifier application number: M022
The Natural Dentist Groovy Grape	FLUORIDE	Caldwell Consumer Health LLC	087abbed-1f58-4b45-a76b-a950fa81c18c	2024-01-16	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Pharma Nobis, LLC	e42fccc2-1b4f-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M022
Sunmark Benzoin Compound Tincture	BENZOIN RESIN	Strategic Sourcing Services LLC	0c96d810-83dc-47d3-9a75-63a79feaad0a	2023-12-19	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	b33b5896-673b-498c-8a58-76ece8552f7a	2023-12-15	Warnings	Exact identifier application number: M022
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier application number: M022
Moon Whitening Gel Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c556a29-a697-3a66-e063-6394a90abfee	2023-12-12	Warnings	Exact identifier application number: M022
Moon Charcoal Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c55f7b3-fea1-58f3-e063-6394a90a3bde	2023-12-12	Warnings	Exact identifier application number: M022
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	0070858b-e02e-431f-a7c2-313fef01791b	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	d1802f08-80cb-41dd-b34d-9c576b101ddb	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	80182c43-100f-4b15-a07e-819599ab9562	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c19e6426-8f1e-47b3-a3a6-551a5bec6cd9	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1f8431bb-f33c-4fd8-9472-9b59ffb5f18e	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1163d248-d648-443e-bed0-ccb7fd26ba63	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	88caabe2-a096-44d0-98d3-afad1935c012	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c1b02a2f-db1f-44f0-a74a-d02c085c5bd7	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	39081585-fe6a-4ba1-93f8-d92d26fe75bc	2023-12-07	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d7c69357-795c-03d8-e053-2a95a90a03a6	2023-12-06	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
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

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	996fdbeb-1fe3-77b6-e053-2995a90a25c7	14
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	996fdbeb-1fe3-77b6-e053-2995a90a25c7	14
2370903	benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Cream	SY	996fdbeb-1fe3-77b6-e053-2995a90a25c7	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0614-9	11822061409	1 TUBE in 1 CARTON (11822-0614-9) / 9.4 g in 1 TUBE	1 tube	2020-05-06	2027-01-01	No	No	Current