3X Medicated Toothache and Gum Gel

Product NDC: 11822-0613
11-digit product format: 118220613
Labeler code: 11822
Product ID: 11822-0613_47b7b1c8-6965-dd9c-e063-6294a90a6417
Type: HUMAN OTC DRUG
Nonproprietary name: Benzocaine
Dosage form: GEL
Route: ORAL
Labeler: Rite Aid
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-06
Marketing end: 2027-11-01
Substance: BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength: 20; .26; .15 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 · 14 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
2025-04-01 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	11822-0613-9	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	11822-0613-9	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	11822-0613-9	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	11822-0613-9	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	11822-0613-9	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	11822-0613-9	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	11822-0613-9	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: 3X Medicated Toothache and Gum Gel

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	20 g/100g
MENTHOL	.26 g/100g
ZINC CHLORIDE	.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
L7T10EIP3A	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
2362013	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
996f7989-17ce-5b28-e053-2995a90af8b8	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-08-12	996f7989-17ce-5b28-e053-2995a90af8b8
2025-08-12	996f7989-17ce-5b28-e053-2995a90af8b8
2025-01-30	996f7989-17ce-5b28-e053-2995a90af8b8
2025-01-30	996f7989-17ce-5b28-e053-2995a90af8b8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-0613-9	3X Medicated Toothache and Gum Gel	1 in 1 CARTON	GEL	1		5
11822-0613-9	3X Medicated Toothache and Gum Gel	11.7 g in 1 TUBE	GEL	11.7		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0613	3X MEDICATED TOOTHACHE AND GUM GEL (BENZOCAINE) GEL [RITE AID]	3	Current NDC, Legacy NDC, 2 package rows	20230115_996f7989-17ce-5b28-e053-2995a90af8b8.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 66 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
QIAN LI ZHUI FENG PAIN RELIEVING	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	MADISON ONE ACME INC	03a4fb7c-2328-409d-99c8-cbcf2b4a451f	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATED	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	05c6b95a-aeb6-4234-97c7-8d77eccb38d8	2025-11-10	Warnings	Exact identifier application number: M017
HEI GUI PAIN RELIEVING	CAMPHOR AND METHYL SALICYLATE	MADISON ONE ACME INC	4140c404-edab-4923-941d-f74125e943a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	ddcc814e-fcc4-4232-9ab4-826b8aac35f0	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017

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
2362013	benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel	PSN	996f7989-17ce-5b28-e053-2995a90af8b8	5
2362013	benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel	SCD	996f7989-17ce-5b28-e053-2995a90af8b8	5
2362013	benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral Gel	SY	996f7989-17ce-5b28-e053-2995a90af8b8	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0613-9	11822061309	1 TUBE in 1 CARTON (11822-0613-9) / 11.7 g in 1 TUBE	1 tube	2020-05-06	2027-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
3X Medicated Toothache and Gum Gel - Rite Aid \| Lornamead Products	Rite Aid \| Lornamead Products	2026-01-06	HUMAN OTC DRUG LABEL	5