MEDI-FIRST

Product NDC: 71927-019
11-digit product format: 719270019
Labeler code: 71927
Product ID: 71927-019_5abd4200-f481-aca6-e063-6294a90ac4bc
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride, Lidocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Orazen Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-29
Substance: LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength: 5; 1.3 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 32 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
2025-08-27 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 product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71927-019-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71927-019-02	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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-019-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-019-02	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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-019-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-019-02	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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-019-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-019-02	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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-019-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-019-02	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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-019-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-019-03	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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-019-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-019-03	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 product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-019-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-019-03	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: MEDI-FIRST
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	5 mg/g
BENZALKONIUM CHLORIDE	1.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012100	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
f508434f-5948-7134-e053-2a95a90a03d7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
71927-019-02	2025-09-03	2cef2736-ac00-d83d-e063-dadaa90ab31f	71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-02	2025-09-03	2cef2736-ac00-d83d-e063-dadaa90ab31f	71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-03	2025-09-03	2cef2736-b243-d83d-e063-dadaa90ab31f	71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine
71927-019-03	2025-09-03	2cef2736-b243-d83d-e063-dadaa90ab31f	71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine
71927-019-02	2025-01-30	2cef2736-ac00-d83d-e063-dadaa90ab31f	71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-02	2025-01-30	2cef2736-ac00-d83d-e063-dadaa90ab31f	71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-03	2025-01-30	2cef2736-b243-d83d-e063-dadaa90ab31f	71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine
71927-019-03	2025-01-30	2cef2736-b243-d83d-e063-dadaa90ab31f	71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71927-019-01	MEDI-FIRST	0.9 g in 1 POUCH	CREAM	0.9	2
71927-019-01	MEDI-FIRST	0.9 g in 1 POUCH	CREAM	0.9	2
71927-019-02	MEDI-FIRST	25 in 1 BOX	CREAM	25	2
71927-019-03	MEDI-FIRST	25 in 1 BOX	CREAM	25	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71927-019	MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC]	1	Current NDC, 2 package rows	20230221_f522fb0b-3d86-b228-e053-2a95a90a55e9.zip
71927-019	MEDI-FIRST (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [ORAZEN INC]	1	Current NDC, 2 package rows	20230220_f508434f-5948-7134-e053-2a95a90a03d7.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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gaayou Numbing	DIBUCAINE HYDROCHLORIDE 0.5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4c290118-7880-2a98-e063-6294a90a4c03	2026-07-21	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving Cold Gel	CAMPHOR, MENTHOL	Active and Innovative	572792bb-2819-36c3-e063-6394a90aa504	2026-07-21	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a36edc5-5a89-afb5-e063-6294a90a02dd	2026-07-21	Warnings	Exact identifier application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	Jiangxi Yudexi Pharmaceutical Co., LTD	4a45c1cb-c5ab-d872-e063-6394a90aab5d	2026-07-21	Warnings	Exact identifier application number: M017
SERYNTH Muscle Comfort	ARNICA MONTANA HPUS 7% MUSCLE COMFORT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c10cd-f0c4-8731-e063-6394a90a10a5	2026-07-21	Warnings	Exact identifier application number: M017
DERMFREE MEDICATED LIP	CAMPHOR 2.0% MEDICATED LIP	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d62fb-8dfa-404a-e063-6294a90a385d	2026-07-21	Warnings	Exact identifier application number: M017
NATUHEAL RELIEF Cream FOR ECZEMA	HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	4c92fed1-a8b4-bda8-e063-6394a90a8a33	2026-07-20	Warnings	Exact identifier application number: M017
REDCOOL Arnica Bruise	ARNICA MONTANA HPUS 7% ARNICA BRUISE	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	49911392-e55e-1a6b-e063-6394a90a9af0	2026-07-20	Warnings	Exact identifier application number: M017
Vamy HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	499197aa-f872-3abf-e063-6294a90aeda2	2026-07-20	Warnings	Exact identifier application number: M017
Subleef NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a201a6b-adde-c0a8-e063-6394a90a8285	2026-07-20	Warnings	Exact identifier application number: M017
PUVIDA NUMBING	MENTHOL 5% (W/W) NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4de4e317-2f4f-e5d6-e063-6394a90a0611	2026-07-20	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	8b607c03-a98f-445a-a69e-7625a76ac44b	2026-07-20	Warnings	Exact identifier application number: M017
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M017
VBBV Numbing	LIDOCAINE	Jiashen International Trade Limited	5716c36b-6e97-c294-e063-6394a90aaf5c	2026-07-20	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	Premier Brands of America Inc.	560c29cc-2453-5d14-e063-6394a90a844f	2026-07-17	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	4981e9c3-2a19-aed8-e063-6294a90af216	2026-07-17	Warnings	Exact identifier application number: M017
endurance wipe	BENZOCAINE	Absorption Pharmaceuticals, LLC	303db1de-94fc-4543-e063-6294a90a01b9	2026-07-17	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare pain relieving gel Extra Strength	CAMPHOR, MENTHOL	Active and Innovative Inc.	56d30c33-ef5a-c63d-e063-6294a90acd29	2026-07-17	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Gel Alpine Fresh Scent	MENTHOL	Carlin Consumer Health LLC	56d3ca3d-21e1-a40a-e063-6294a90a9ff4	2026-07-17	Warnings	Exact identifier application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT Patch	MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b83ee8-8d86-9436-e063-6294a90a0c25	2026-07-16	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
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	f508434f-5948-7134-e053-2a95a90a03d7	2
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	f522fb0b-3d86-b228-e053-2a95a90a55e9	2
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	f508434f-5948-7134-e053-2a95a90a03d7	2
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	f522fb0b-3d86-b228-e053-2a95a90a55e9	2
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	f508434f-5948-7134-e053-2a95a90a03d7	2
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	f522fb0b-3d86-b228-e053-2a95a90a55e9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71927-019-01	71927001901	0.9 g in 1 POUCH	0.9 g				Historical
71927-019-02	71927001902	25 POUCH in 1 BOX (71927-019-02) / .9 g in 1 POUCH (71927-019-01)	25 pouch	2025-08-29	No	No	Current
71927-019-03	71927001903	25 POUCH in 1 BOX (71927-019-03) / .9 g in 1 POUCH (71927-019-01)	25 pouch	2025-09-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine	Orazen Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-09-05	HUMAN OTC DRUG LABEL	3
71729-019-01, 03 MEDI-FIRST PLUS Burn cream with Lidocaine	Orazen Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-09-05	HUMAN OTC DRUG LABEL	3