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 74 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROINNATE Numbing Cream	MENTHOL	Guangzhou Haishi Biological Technology Co., Ltd.	40c63645-8ed3-82b3-e063-6294a90a5267	2025-10-13	Warnings	Exact identifier application number: M017
Cramergesic	MENTHOL, METHYL SALICYLATE	The Hygenic Company, LLC	d0ffde7a-6942-74fc-e053-2a95a90a484a	2025-10-13	Warnings	Exact identifier application number: M017
Tricylate	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Trifluent Pharma LLC	4869b63a-e01e-4a79-a493-7a1b4d3e914b	2025-10-13	Warnings	Exact identifier application number: M017
Doloflex Pain Relief	MENTHOL, METHYL SALICYLATE	United Health & Beauty Corp	32a830cc-04d3-102e-e063-6294a90a1cad	2025-10-12	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Gel-Patch	LIDOCAINE	Nanjing Anxing Medical Technology Co., Ltd.	40c9b132-57ce-865e-e063-6394a90a2080	2025-10-10	Warnings	Exact identifier application number: M017
Kinesys	ZINC OXIDE	Wilc Healthcare Inc	a32b44c3-eda0-48ea-95fc-250a2c2396ca	2025-10-10	Warnings	Exact identifier application number: M017
Te-Fu Recovery Massage	MENTHOL, METHYL SALICYLATE	Wasatch Product Development	7bc2989f-dfb6-e8af-e053-2991aa0a0bf2	2025-10-10	Warnings	Exact identifier application number: M017
Anti-itch	HYDROCORTISONE	Medline Industries, LP	b0947381-c0db-4253-ab40-3d45603ae65d	2025-10-09	Warnings	Exact identifier application number: M017
Kalaya Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e2452c4b-2548-497f-828b-5d960402522a	2025-10-08	Warnings	Exact identifier application number: M017
Kalaya Pain Relief 6X with Arnica	PAIN RELIEF CREAM	Avaria Health & Beauty Corp	60198d2e-4de3-3fa0-e053-2a91aa0afaf7	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	9b9b7cad-a5e2-4445-856b-4aa439d77a80	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	d5021e6d-f29f-446b-874c-bdcabd9cf4f6	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e0c9f22a-165a-4558-ba3c-8592f1bd0016	2025-10-08	Warnings	Exact identifier application number: M017
Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	2eccf23c-fae2-423c-9cae-549bc4194104	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA BACK AND NECK PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	48fd73e7-1443-4ac7-bf7c-d99bf2449f51	2025-10-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Patch	LIDOCAINE 4%	BluePoint Laboratories	3117273d-e006-2726-e063-6294a90a9c33	2025-10-08	Warnings	Exact identifier application number: M017
EQUATE PAIN RELIEVING PATCHES	LIDOCAINE 4%	WALMART, INC	01e1cc0e-e1c9-d274-e063-6294a90a409e	2025-10-08	Warnings	Exact identifier application number: M017
Equate Pain Relief Balm	MENTHOL 11%, CAMPHOR 11% OINTMENT	WALMART, INC	d8ddf835-f008-ce1f-e053-2a95a90aa9b3	2025-10-08	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Menthol Gel	MENTHOL 2%	Veridian Healthcare	9d2ccb02-746c-4cb9-905d-280987778f4d	2025-10-08	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	3a9019b1-8798-1ef9-e063-6394a90a09a4	2025-10-08	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