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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	Warnings	Exact identifier application number: M017
PURE EASE Joint Muscle lnstant Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	42bf129c-5c84-4331-b6d0-78e3be71a985	2023-11-13	Warnings	Exact identifier application number: M017
PURE EASE Neur Cream Instant Deep Pain Relief	CAPSAICIN, MENTHOL	SERENU, INC.	e46a4636-6405-440a-a05a-862c354bab54	2023-11-13	Warnings	Exact identifier application number: M017
Cryomax Cooling	MENTHOL	LIFE WEAR TECHNOLOGIES	0a0ae5ba-9fac-45f6-e063-6294a90ad555	2023-11-13	Warnings	Exact identifier application number: M017
LBri Super Aloe Stop The Pain	METHYL SALICYLATE, MENTHOL, CAPSAICIN	L'Bris, Pure 'N Natural	8fb2010c-c34b-4552-858d-a0188ad313ad	2023-11-11	Warnings	Exact identifier application number: M017
TOTAL RELIEF	HYDROCORTISONE	DR. MARDER SKINCARE, LLC	2c05459c-5a2c-45ab-b534-87f966b41681	2023-11-11	Warnings	Exact identifier application number: M017
Human Science Muscle Pain Relief	METHYL SALICYLATE, MENTHOL	Human Science, LLC	4bccc017-264b-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma, LLC	55108ffd-d6a8-41de-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
Debbies Down and Dirty Deep Tissue Joint and Muscle	MENTHOL	DD&D Manufacturing Co., Ltd	531fe834-53e3-305f-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M017
TerraFreeze Pain Relief	MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE	Beyond Derma, LLC	81dc70b3-7e93-4f9a-ae3a-b50bbfd1a677	2023-11-11	Warnings	Exact identifier application number: M017
GOLD ICE Pain Relief	MENTHOL	Eden's Answers, Inc.	a1356c39-42b9-4bd8-a873-bcd40717058b	2023-11-11	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