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		2026-10-20
excluded package	package	68229-201	68229-201-14	D	Discontinued by firm		2026-10-20

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 106 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	Warnings	Exact identifier application number: M017
OKeeffes Working Hands Pain Relief Skin Protectant	ALLANTOIN, LIDOCAINE HYDROCHLORIDE	The Gorilla Glue Company/O'Keeffe's Company	0685da25-c9fa-e1cd-e063-6394a90ae1b3	2025-01-01	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine Pain Relieving	LIDOCAINE HCL AND MENTHOL	Chattem, Inc.	75b28b06-77ea-4fea-b516-2e8a0dac7037	2025-01-01	Warnings	Exact identifier application number: M017
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Fragrance-Free	HYDROCORTISONE	Lovely Skin, Inc.	c12af4c6-2f05-46ec-b901-1a4fcd750180	2024-12-31	Warnings	Exact identifier application number: M017
Pain Relieving Cream Lidocaine	BENZYL ALCOHOL, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	039a2036-54b2-cf28-e063-6294a90a8ce6	2024-12-31	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief Walgreens	MENTHOL 10.5%	WALGREEN COMPANY	f1daa68d-1b12-c28a-e053-2995a90a0949	2024-12-31	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Advanced Rx of Tennessee, LLC	0b7736df-c7e0-7d00-e063-6294a90aa57e	2024-12-31	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Advanced Rx Pharmacy of Tennessee, LLC	f4bfc4a6-06ef-1f76-e053-2995a90a2b8f	2024-12-31	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Safeway	af2e2ef3-0f3f-4592-8081-b6553ade2f5a	2024-12-26	Warnings	Exact identifier application number: M017
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier application number: M017
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier application number: M017
BiteMD External Analgesic First Aid Antiseptic	BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL	United Industries Corporation	4c60db03-6d2b-4ae0-a200-718b3a50eb0f	2024-12-23	Warnings	Exact identifier application number: M017
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier application number: M017
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier application number: M017
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	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