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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MyDerm Aloe and Lidocaine	LIDOCAINE	Medline Industries	fdfd4388-cd27-467b-959b-249a49ea5cf6	2026-05-26	Warnings	Exact identifier application number: M017
MyDerm Aloe and Lidocaine	LIDOCAINE	Inspec Solutions LLC.	4939c663-a876-4527-822a-df02964fa694	2026-05-26	Warnings	Exact identifier application number: M017
Lidocaine Menthol Pain Relief	LIDOCAINE, MENTHOL	Amerisource Bergen	94039190-dde3-4d8e-873a-79abd3f6208b	2026-05-26	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	858053a0-d888-4bb9-b94e-503bcf3864cb	2026-05-21	Warnings	Exact identifier application number: M017
Arthritis Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	523333ee-eccd-bcf7-e063-6394a90aea60	2026-05-21	Warnings	Exact identifier application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving Drops	MENTHOL	NEWMARKET HEALTH PRODUCTS, LLC	068343b8-0435-40d0-846c-9d8624e8b6c4	2026-05-21	Warnings	Exact identifier application number: M017
DO ME DELAY	LIDOCAINE HCL	Prodigy Media Inc	5255ee85-6f29-0776-e063-6394a90a525b	2026-05-21	Warnings	Exact identifier application number: M017
Australian Dream Back Pain	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	5256a63e-e6da-84c1-e063-6294a90a8dff	2026-05-21	Warnings	Exact identifier application number: M017
SINSIN HANBANG FLEX	CAMPHOR, MENTHOL	Sinsin Pharmaceutical co., ltd.	525c5d18-bfc1-3002-e063-6394a90a5b1d	2026-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Preferred Pharmaceuticals Inc.	6c9a076e-6316-427b-9ce6-c8fe2d388837	2026-05-21	Warnings	Exact identifier application number: M017
Medi-First Capsaicin Cream	CAPSAICIN	Unifirst First Aid Corporation	49eb807b-fa31-3d84-e063-6394a90acfcf	2026-05-20	Warnings	Exact identifier application number: M017
Biofreeze Triple Target Roll-On	CAMPHOR, CAPSAICIN, MENTHOL	Reckitt Benckiser LLC	5089c088-3026-233a-e063-6394a90a93b6	2026-05-19	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	522f1521-f9f2-4c26-e063-6394a90a9e05	2026-05-19	Warnings	Exact identifier application number: M017
Easment 0.1% Capsaicin Roll on	CAPSAICIN 0.1%	Easment LLC	521212d6-57fd-4a7a-e063-6294a90a2a18	2026-05-18	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	WALMART INC.	15af4557-4baf-c177-e063-6294a90a7a5b	2026-05-18	Warnings	Exact identifier application number: M017
Blistex Maximum Hydration Lip	CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	fed223bc-edf3-46eb-b678-acb906f9ef11	2026-05-18	Warnings	Exact identifier application number: M017
Tiger Balm	CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	5066dc10-e4d5-49e9-9a5f-0ac220cfbf28	2026-05-18	Warnings	Exact identifier application number: M017
Deep Blue Mini	MENTHOL	doTERRA International, LLC	51dd58a8-1fd5-9cd7-e063-6394a90a1f72	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Overnight Gel	MENTHOL	Reckitt Benckiser LLC	f5c8c08b-c7c0-f84d-e053-2a95a90add15	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	00bba5d2-b0e0-701c-e063-6294a90a5741	2026-05-15	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