Burn Jel

Product NDC: 59898-200
11-digit product format: 598980200
Labeler code: 59898
Product ID: 59898-200_2b0a5dfa-c7dd-d8e6-e063-6294a90ac37c
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: GEL
Route: TOPICAL
Labeler: Water-Jel Technologies
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-04-17
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 2 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

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-11	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-13	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-17	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-49	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-35	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59898-200-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-11	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-13	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-17	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-49	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-35	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59898-200-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-11	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-13	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-17	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-49	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-16	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-35	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59898-200-15	`bd6a592717d7…`	`303034d00443…`

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: Burn Jel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	2 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011852	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
ff621b46-2342-41db-994d-851a09796d08	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59898-200-11	2023-03-14	Burn Jel
59898-200-13	2023-03-14	Burn Jel
59898-200-15	2023-03-14	Burn Jel
59898-200-16	2023-03-14	Burn Jel
59898-200-17	2023-03-14	Burn Jel
59898-200-35	2023-03-14	Burn Jel
59898-200-49	2023-03-14	Burn Jel
59898-200-11	2022-01-28	Burn Jel
59898-200-13	2022-01-28	Burn Jel
59898-200-15	2022-01-28	Burn Jel
59898-200-16	2022-01-28	Burn Jel
59898-200-17	2022-01-28	Burn Jel
59898-200-35	2022-01-28	Burn Jel
59898-200-49	2022-01-28	Burn Jel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59898-200-10	Burn Jel	59 mL in 1 BOTTLE, PLASTIC	GEL	59	5
59898-200-11	Burn Jel	24 in 1 CARTON	GEL	24	5
59898-200-12	Burn Jel	118 mL in 1 BOTTLE, PLASTIC	GEL	118	5
59898-200-13	Burn Jel	24 in 1 CARTON	GEL	24	5
59898-200-15	Burn Jel	3.5 mL in 1 PACKET	GEL	3.5	5
59898-200-15	Burn Jel	25 in 1 BOX	GEL	25	5
59898-200-16	Burn Jel	6 in 1 BOX	GEL	6	5
59898-200-16	Burn Jel	3.5 mL in 1 PACKET	GEL	3.5	5
59898-200-17	Burn Jel	3.5 mL in 1 PACKET	GEL	3.5	5
59898-200-17	Burn Jel	1728 in 1 CARTON	GEL	1728	5
59898-200-35	Burn Jel	3.5 mL in 1 PACKET	GEL	3.5	5
59898-200-49	Burn Jel	10 in 1 KIT	GEL	10	5
59898-200-49	Burn Jel	3.5 mL in 1 PACKET	GEL	3.5	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
LIDOCAINE	ACTIVE MOIETY	98PI200987	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	7
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
LIDOCAINE	ACTIVE MOIETY	98PI200987	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	4
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BURN JEL (GEL FOR BURNS) GEL [WATER-JEL TECHNOLOGIES]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59898-200	IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	8	Current NDC, Legacy NDC	20171212_f291841e-ccbd-4f5a-b1de-4cf596a167e3.zip
59898-200	BURN JEL (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES]	5	Current NDC, Legacy NDC, 13 package rows	20250108_ff621b46-2342-41db-994d-851a09796d08.zip
59898-200	EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	5	Current NDC, Legacy NDC	20171208_7e21b96a-3d89-4d1c-9ec6-0611f6c9c625.zip
59898-200	FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	5	Current NDC, Legacy NDC	20171212_4c62196a-9f94-4823-b95f-447f012f10bf.zip
59898-200	EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]	3	Current NDC, Legacy NDC	20171212_0d2631c1-93fc-478c-afed-0f175a7e8555.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 68 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY	Topco Associates LLC	8026c7dd-eb7b-ebea-e053-2991aa0a1b0f	2025-11-06	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	Walgreen Company	6057b4ff-6adc-4688-893c-62d237d7d1ae	2025-11-06	Warnings	Exact identifier application number: M017
BANPINGHUA Glucosamine Chondroitin Patch	PEPPERMINT, CAMPHOR, BORNEOL	Henan Lijitang Medical Technology Co., Ltd.	42f8c2ae-50a2-2358-e063-6394a90a5979	2025-11-06	Warnings	Exact identifier application number: M017
PAINGEL	CAMPHOR, MENTHOL	NACOR BUSINESS GROUP LLC	42fa2397-b61a-3b16-e063-6294a90a5fed	2025-11-06	Warnings	Exact identifier application number: M017
PAINGEL UNGUENTO	CAMPHOR, MENTHOL	NACOR BUSINESS GROUP LLC	42fab525-b0a5-97fb-e063-6394a90aec6c	2025-11-06	Warnings	Exact identifier application number: M017
PAINGEL ROLL-ON	MENTHOL	NACOR BUSINESS GROUP LLC	42fb0bdf-8bbd-bbe3-e063-6294a90a656c	2025-11-06	Warnings	Exact identifier application number: M017
Coolexa	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rising Pharma Holdings, Inc.	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	2025-11-06	Warnings	Exact identifier application number: M017
ItchZap	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Rising Pharma Holdings, Inc.	245d0afb-19a8-4cfb-968b-d892b18d5f2c	2025-11-06	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	LIDOCAINE AND MENTHOL	Bullet point LLC	42c70681-494b-47c9-e063-6394a90a80be	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	ba6c7e97-d740-484b-8711-55fa7ab15784	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, Inc.	d7c5cb17-f7a2-7f57-e053-2995a90a40f7	2025-11-04	Warnings	Exact identifier application number: M017
Aulief Topical Pain Reliever	MENTHOL AND CAMOHOR	China-Gel, LLC	8647dcc3-1dbc-1093-e053-2991aa0a1ab9	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	254abae9-ef1b-5a90-e054-00144ff88e88	2025-11-04	Warnings	Exact identifier application number: M017
Pain Relief Gel-Tube	MENTHOL	Bullet point LLC	42c93789-9758-54b7-e063-6394a90ac398	2025-11-04	Warnings	Exact identifier application number: M017
Tattoo care	TATTOO CARE CREAM	Perfso (HK) Co., Limited	42d0f56f-9cb1-8e19-e063-6394a90aa3e0	2025-11-04	Warnings	Exact identifier application number: M017
CORE RELIEF	CAMPHOR, MENTHOL	Copper Joint, LLC	42d17270-f58d-9d69-e063-6294a90a4078	2025-11-04	Warnings	Exact identifier application number: M017
Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Marcella Health	d25f25ee-79f8-49e7-9715-0aae305b73e5	2025-11-03	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS NO TOUCH SPRAY	Premier Brands of America Inc.	36481d67-2346-470b-e063-6294a90aae99	2025-11-03	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE 5%	YYBA Corp	1319ee69-8b3f-5815-e063-6294a90a5ad5	2025-11-03	Warnings	Exact identifier application number: M017
Goodsense Extra Strength Cold and Hot Medicated	MENTHOL	Geiss, Destin and Dunn, Inc.	7585d111-775f-4fb6-a485-28cd99d88852	2025-10-31	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
1011852	lidocaine HCl 2 % Topical Gel	PSN	f291841e-ccbd-4f5a-b1de-4cf596a167e3	8
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	f291841e-ccbd-4f5a-b1de-4cf596a167e3	8
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	f291841e-ccbd-4f5a-b1de-4cf596a167e3	8
1011852	lidocaine HCl 2 % Topical Gel	PSN	4c62196a-9f94-4823-b95f-447f012f10bf	5
1011852	lidocaine HCl 2 % Topical Gel	PSN	7e21b96a-3d89-4d1c-9ec6-0611f6c9c625	5
1011852	lidocaine HCl 2 % Topical Gel	PSN	ff621b46-2342-41db-994d-851a09796d08	5
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	4c62196a-9f94-4823-b95f-447f012f10bf	5
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	7e21b96a-3d89-4d1c-9ec6-0611f6c9c625	5
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	ff621b46-2342-41db-994d-851a09796d08	5
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	4c62196a-9f94-4823-b95f-447f012f10bf	5
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	7e21b96a-3d89-4d1c-9ec6-0611f6c9c625	5
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	ff621b46-2342-41db-994d-851a09796d08	5
1011852	lidocaine HCl 2 % Topical Gel	PSN	0d2631c1-93fc-478c-afed-0f175a7e8555	3
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	0d2631c1-93fc-478c-afed-0f175a7e8555	3
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	0d2631c1-93fc-478c-afed-0f175a7e8555	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59898-200-10	59898020010	59 mL in 1 BOTTLE, PLASTIC	59 ml					Historical
59898-200-11	59898020011	24 BOTTLE, PLASTIC in 1 CARTON (59898-200-11) / 59 mL in 1 BOTTLE, PLASTIC (59898-200-10)		2010-04-17	0000-00-00	No	No	Current
59898-200-12	59898020012	118 mL in 1 BOTTLE, PLASTIC	118 ml					Historical
59898-200-13	59898020013	24 BOTTLE, PLASTIC in 1 CARTON (59898-200-13) / 118 mL in 1 BOTTLE, PLASTIC (59898-200-12)		2010-04-17	0000-00-00	No	No	Current
59898-200-15	59898020015	25 PACKET in 1 BOX (59898-200-15) / 3.5 mL in 1 PACKET	25 packet	2010-04-17	0000-00-00	No	No	Current
59898-200-16	59898020016	6 PACKET in 1 BOX (59898-200-16) / 3.5 mL in 1 PACKET	6 packet	2010-04-17	0000-00-00	No	No	Current
59898-200-17	59898020017	1728 PACKET in 1 CARTON (59898-200-17) / 3.5 mL in 1 PACKET	1728 packet	2010-04-17	0000-00-00	No	No	Current
59898-200-35	59898020035	3.5 mL in 1 PACKET (59898-200-35)	3.5 ml	2010-04-17	0000-00-00	No	No	Current
59898-200-49	59898020049	10 PACKET in 1 KIT (59898-200-49) / 3.5 mL in 1 PACKET	10 packet	2010-04-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Burn Jel	Water-Jel Technologies	2025-01-06	HUMAN OTC DRUG LABEL	5
0498-4331: First Aid Kit (EW, Burn Jel, PVP wipes, alcohol wipes- Z019811)	Honeywell Safety Products USA, INC	2024-01-22	HUMAN OTC DRUG LABEL	6
IWK-5	Water-Jel Technologies	2017-12-07	HUMAN OTC DRUG LABEL	8
FSK-5	Water-Jel Technologies	2017-12-07	HUMAN OTC DRUG LABEL	5
EBSS-5	Water-Jel Technologies	2017-12-07	HUMAN OTC DRUG LABEL	5
EBSL-5	Water-Jel Technologies	2017-12-07	HUMAN OTC DRUG LABEL	3