Alocane Emergency Burn

Product NDC: 68229-201
11-digit product format: 682290201
Labeler code: 68229
Product ID: 68229-201_262e0e1d-21b6-be5e-e063-6394a90ab0aa
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: GEL
Route: TOPICAL
Labeler: Quest Products, LLC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-01
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 4 g/100mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68229-201	68229-201-12	D	Discontinued by firm		2026-10-12
excluded package	package	68229-201	68229-201-14	D	Discontinued by firm		2026-10-12

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 · 21 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	68229-201-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	68229-201-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	68229-201-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	68229-201-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	68229-201-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	68229-201-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	68229-201-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	68229-201-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	68229-201-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	68229-201-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	68229-201-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	68229-201-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	68229-201-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	68229-201-14	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	68229-201-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	68229-201-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	68229-201-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	68229-201-14	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	68229-201-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	68229-201-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	68229-201-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Alocane Emergency Burn
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010077	Internal RxNorm lookup
1875237	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
0c8e65a6-dff3-43b4-a3f1-95deb574ea89	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68229-201-01	Alocane Emergency Burn	110 mL in 1 TUBE	GEL	110	14
68229-201-02	Alocane Emergency Burn	1 in 1 CARTON	GEL	1	14
68229-201-03	Alocane Emergency Burn	110 mL in 1 BOTTLE, SPRAY	GEL	110	14
68229-201-04	Alocane Emergency Burn	3.4 mL in 1 PACKET	GEL	3.4	14
68229-201-05	Alocane Emergency Burn	24 in 1 CARTON	GEL	24	14
68229-201-06	Alocane Emergency Burn	3.4 mL in 1 PACKET	GEL	3.4	14
68229-201-07	Alocane Emergency Burn	45 in 1 CARTON	GEL	45	14
68229-201-08	Alocane Emergency Burn	103.507 mL in 1 BOTTLE, SPRAY	GEL	103.507	14
68229-201-09	Alocane Emergency Burn	118.294 mL in 1 TUBE	GEL	118.294	14
68229-201-10	Alocane Emergency Burn	1 in 1 CARTON	GEL	1	14
68229-201-11	Alocane Emergency Burn	133.081 mL in 1 BOTTLE, SPRAY	GEL	133.081	14
68229-201-12	Alocane Emergency Burn	1 in 1 KIT	GEL	1	14
68229-201-13	Alocane Emergency Burn	1 in 1 CARTON	GEL	1	14
68229-201-14	Alocane Emergency Burn	946 mL in 1 BOTTLE, PUMP	GEL	946	14
68229-201-15	Alocane Emergency Burn	800 mL in 1 BAG	GEL	800	14
68229-201-16	Alocane Emergency Burn	124 mL in 1 BOTTLE, SPRAY	GEL	124	14
68229-201-17	Alocane Emergency Burn	22 mL in 1 TUBE	GEL	22	14
68229-201-18	Alocane Emergency Burn	1 in 1 CARTON	GEL	1	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68229-201	ALOCANE EMERGENCY BURN (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.]	14	Current NDC, Legacy NDC, 18 package rows	20241107_0c8e65a6-dff3-43b4-a3f1-95deb574ea89.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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Overnight Roll-on	MENTHOL	Reckitt Benckiser LLC	f67d7b7a-8922-73f6-e053-2995a90a2e80	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Overnight Relief	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	07be6e88-1850-4d6a-946d-f03830b8c4a2	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Roll-On and Overnight Roll-On	MENTHOL	Reckitt Benckiser LLC	4d3dcb8f-2075-6bbc-e063-6394a90a4992	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	6bef9ccb-7a5a-4c67-b1bc-a92b167312da	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Roll-On	MENTHOL	Reckitt Benckiser LLC	ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Precision Relief Pen	MENTHOL	Reckitt Benckiser LLC	b4cc1db5-a33f-17bc-e053-2995a90ab7eb	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	db982baf-31ea-4f09-90e3-cd5facb5dfe5	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional Roll-On	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	f62f8ec3-593d-480a-85a0-01fcd7f1790c	2026-05-15	Warnings	Exact identifier application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON	MENTHOL	Reckitt Benckiser LLC	8af185ad-719e-4684-89c0-9c17c1277499	2026-05-15	Warnings	Exact identifier application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVING	MENTHOL	Reckitt Benckiser LLC	ef158f63-2d75-47a3-b94a-2d821d511863	2026-05-15	Warnings	Exact identifier application number: M017
KY Duration for Him	LIDOCAINE	Reckitt Benckiser LLC	83cc86bd-3303-4956-a198-fae85b6e34e1	2026-05-15	Warnings	Exact identifier application number: M017
4% LIDOCAINE PATCHES	4% LIDOCAINE	Shenzhen Huayuan Hengsheng Technology Co., Ltd.	4f53cfd3-a7c4-e308-e063-6294a90ad698	2026-05-14	Warnings	Exact identifier application number: M017
Cold and Heat Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Cardinal Health, 110 dba LEADER	77066d01-75b0-4a8d-88d3-c639626d3326	2026-05-14	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	LIDOCAINE	Trifecta Pharmaceuticals USA	51cb6797-55ec-7a7a-e063-6294a90a90ee	2026-05-14	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	MENTHOL	Trifecta Pharmaceuticals USA	51b403dc-fc9b-0cad-e063-6394a90af081	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	5edddb99-6596-4a3b-b361-1cc04d032c31	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	684faf63-5e44-4471-8384-e8fa7c0d842a	2026-05-13	Warnings	Exact identifier application number: M017
Biofreeze	MENTHOL	Reckitt Benckiser LLC	4c798b06-6ee5-41d1-8a14-f6889512ade3	2026-05-13	Warnings	Exact identifier application number: M017
BIOFREEZE	MENTHOL	Reckitt Benckiser LLC	83d5c2f2-2413-4d28-83b2-0808d0917b4d	2026-05-13	Warnings	Exact identifier application number: M017
Scalpicin Anti-Itch Maximum Strength	HYDROCORTISONE	Reckitt Benckiser LLC	7b1a29fa-b266-43e6-a87b-aa3c96ab4041	2026-05-13	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1875237	Alocane 4 % Topical Gel	PSN	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1010077	lidocaine HCl 4 % Topical Gel	PSN	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1875237	lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane]	SBD	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1010077	lidocaine hydrochloride 0.04 MG/MG Topical Gel	SCD	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1875237	Alocane 0.04 MG/MG Topical Gel	SY	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1875237	Alocane 4 % Topical Gel	SY	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14
1010077	lidocaine hydrochloride 4 % Topical Gel	SY	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68229-201-01	68229020101	110 mL in 1 TUBE	110 ml					Historical
68229-201-02	68229020102	1 TUBE in 1 CARTON (68229-201-02) / 110 mL in 1 TUBE (68229-201-01)	1 tube	2019-03-01	0000-00-00	No	No	Current
68229-201-03	68229020103	110 mL in 1 BOTTLE, SPRAY (68229-201-03)	110 ml	2020-03-01	0000-00-00	No	No	Current
68229-201-04	68229020104	3.4 mL in 1 PACKET	3.4 ml					Historical
68229-201-05	68229020105	24 PACKET in 1 CARTON (68229-201-05) / 3.4 mL in 1 PACKET (68229-201-04)	24 packet	2020-03-01	0000-00-00	No	No	Current
68229-201-06	68229020106	3.4 mL in 1 PACKET	3.4 ml					Historical
68229-201-07	68229020107	45 PACKET in 1 CARTON (68229-201-07) / 3.4 mL in 1 PACKET (68229-201-06)	45 packet	2020-03-01	0000-00-00	No	No	Current
68229-201-08	68229020108	103.507 mL in 1 BOTTLE, SPRAY (68229-201-08)	103.507 ml	2020-03-01	0000-00-00	No	No	Current
68229-201-09	68229020109	118.294 mL in 1 TUBE	118.294 ml					Historical
68229-201-10	68229020110	1 TUBE in 1 CARTON (68229-201-10) / 118.294 mL in 1 TUBE (68229-201-09)	1 tube	2019-03-01	0000-00-00	No	No	Current
68229-201-11	68229020111	133.081 mL in 1 BOTTLE, SPRAY (68229-201-11)	133.081 ml	2020-03-01	0000-00-00	No	No	Current
68229-201-12	68229020112	1 BAG in 1 KIT (68229-201-12) > 800 mL in 1 BAG (68229-201-15)	1 bag	2019-03-01	0000-00-00	No	No	Current
68229-201-13	68229020113	1 BAG in 1 CARTON (68229-201-13) / 800 mL in 1 BAG (68229-201-15)	1 bag	2019-03-01	0000-00-00	No	No	Current
68229-201-14	68229020114	946 mL in 1 BOTTLE, PUMP (68229-201-14)	946 ml	2019-03-01	0000-00-00	No	No	Current
68229-201-15	68229020115	800 mL in 1 BAG	800 ml					Historical
68229-201-16	68229020116	124 mL in 1 BOTTLE, SPRAY (68229-201-16)	124 ml	2022-11-11	0000-00-00	No	No	Current
68229-201-17	68229020117	22 mL in 1 TUBE	22 ml					Historical
68229-201-18	68229020118	1 TUBE in 1 CARTON (68229-201-18) / 22 mL in 1 TUBE (68229-201-17)	1 tube	2021-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alocane ® Emergency Burn Gel	Quest Products, LLC. \| Fill Tech USA	2024-11-05	HUMAN OTC DRUG LABEL	14