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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOGUARD	LIDOCAINE 4%	ViolaCare, Inc.	d8b021b6-cf71-4f7e-9d27-92d0982bd34f	2026-03-25	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	4dda6ac4-d849-69a6-e063-6394a90a3c54	2026-03-25	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a33f9a9-1fdc-7cdf-e063-6294a90adca1	2026-03-25	Warnings	Exact identifier application number: M017
EjaGuard	LIDOCAINE	MOLANSPACE INC	475f64ef-d636-7e87-e063-6294a90ae32f	2026-03-25	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4e53d29c-ed3c-f481-e063-6294a90a3181	2026-03-25	Warnings	Exact identifier application number: M017
Topicaine Ultra	TOPICAINE ULTRA	Oncora Pharma, LLC	e052f718-700a-44e0-8770-65451b812ee1	2026-03-24	Warnings	Exact identifier application number: M017
Hot Pap Cataplasma	METHYL SALICYLATE, VANILLYL NONYLAMIDE	Masaem Company	4dbeda13-b198-0cf0-e063-6294a90a8180	2026-03-24	Warnings	Exact identifier application number: M017
Barmicil Anti-itch	HYDROCORTISONE	OPMX LLC	850084c3-1dd4-eb8d-e053-2a91aa0a130b	2026-03-24	Warnings	Exact identifier application number: M017
Jeil Hangbang Paff Soo S Cataplasma	GLYCOL SALICYLATE, L-MENTHOL	Masaem Company	4dd040db-07cf-361a-e063-6394a90a8001	2026-03-24	Warnings	Exact identifier application number: M017
Zenol Double Action	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4da998fc-75a3-583f-e063-6394a90a59c7	2026-03-23	Warnings	Exact identifier application number: M017
Ultra Strength Topical Pain Relief Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD	4db9ae57-4ab4-8fe4-e063-6394a90a7e51	2026-03-23	Warnings	Exact identifier application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON	ALIVIO TOTAL ROLL ON	EVI LABS	4da01338-8739-08a8-e063-6294a90ae157	2026-03-22	Warnings	Exact identifier application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTAL	ALIVIO TOTAL	EVI LABS	4da1c3b8-9af2-6e9f-e063-6394a90a86ae	2026-03-22	Warnings	Exact identifier application number: M017
SORE NO MORE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd	2026-03-20	Warnings	Exact identifier application number: M017
CVS Health Antiseptic Wound Wash	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	CVS Pharmacy	53ac017a-eccb-3b24-e054-00144ff88e88	2026-03-20	Warnings	Exact identifier application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%	ANTI ITCH GEL	Walgreens	3d6e8c62-2fcc-51c2-e063-6394a90a33f7	2026-03-20	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5c52d7-8e81-b62f-e063-6394a90ad03e	2026-03-19	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d47e8c7-d293-bf63-e063-6294a90a5fd9	2026-03-18	Warnings	Exact identifier application number: M017
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	f7aa9330-c47c-4d2f-b784-11b831d919d6	2026-03-18	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	99726aa3-3b45-4175-8471-279419af5457	2026-03-18	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