Select Brand Burn Relief

Product NDC: 15127-002
11-digit product format: 151270002
Labeler code: 15127
Product ID: 15127-002_b3b33a6e-ec28-4c64-ac57-da170dec6eb3
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HCL
Dosage form: GEL
Route: TOPICAL
Labeler: Select Brand Distributors
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-11-19
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 1 g/100g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 product	product	15127-002		I	Inactivated by FDA		2026-08-11
excluded package	package	15127-002	15127-002-16	I	Inactivated by FDA		2026-08-11

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	15127-002-16	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	15127-002-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	15127-002-16	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	15127-002-16	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	15127-002-16	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	15127-002-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	15127-002-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	15127-002-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	15127-002-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	15127-002-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	15127-002-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	15127-002-16	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	15127-002-16	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	15127-002-16	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	15127-002-16	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	15127-002-16	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	15127-002-16	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	15127-002-16	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	15127-002-16	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	15127-002-16	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	15127-002-16	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	15127-002-16	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15127-002-16	2020-01-31	C162847	48780-1	9d75b9cf-e3c3-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15127-002-16	Select Brand Burn Relief	226 g in 1 BOTTLE, PLASTIC	GEL	226		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15127-002	SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]	1	Legacy NDC, 1 package rows	20121122_a74fd985-2b1d-4849-9a91-ee82f8dcab29.zip

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
1011849	lidocaine HCl 0.5 % Topical Gel	PSN	a74fd985-2b1d-4849-9a91-ee82f8dcab29	1
1011849	lidocaine hydrochloride 0.005 MG/MG Topical Gel	SCD	a74fd985-2b1d-4849-9a91-ee82f8dcab29	1
1011849	lidocaine hydrochloride 0.5 % Topical Gel	SY	a74fd985-2b1d-4849-9a91-ee82f8dcab29	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
15127-002-16	15127000216	226 g in 1 BOTTLE, PLASTIC	226 g	Historical