MEDI-FIRST Topical Analgesic

Product NDC: 78495-142
11-digit product format: 784950142
Labeler code: 78495
Product ID: 78495-142_5aebcb33-8dcd-d9bc-e063-6294a90a555e
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine HCI
Dosage form: SPRAY
Route: TOPICAL
Labeler: Ultra Distributors Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-19
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
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 · 14 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
2025-04-01 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	78495-142-01	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 package	package	78495-142-01	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 package	package	78495-142-01	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 package	package	78495-142-01	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 package	package	78495-142-01	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 package	package	78495-142-01	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 package	package	78495-142-01	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 Topical Analgesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010769	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
b6f288f7-9ae3-215e-e053-2a95a90aedf6	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#

Effective, Related label table
Effective	Related label
2025-04-07	78495-142
2025-04-07	78495-142 MEDI-FIRST Topical Analgesic
2025-01-30	78495-142
2025-01-30	78495-142 MEDI-FIRST Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78495-142-01	MEDI-FIRST Topical Analgesic	59.1 mL in 1 BOTTLE, PUMP	SPRAY	59.1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78495-142	MEDI-FIRST TOPICAL ANALGESIC (LIDOCAINE HCI) SPRAY [ULTRA DISTRIBUTORS INC]	2	Current NDC, Legacy NDC, 1 package rows	20250409_b6f288f7-9ae3-215e-e053-2a95a90aedf6.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 151 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fefbe351-1cd9-4a2f-a43d-51e2c4eb180b	2023-10-24	Warnings	Exact identifier application number: M017
TheraPlus Plus	MENTHOL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	d4119f84-eb60-4134-b58e-de13d9601199	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Exact identifier application number: M017
NUMOTIZINE	MENTHOL	Hobart Laboratories, Inc.	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	2023-10-20	Warnings	Exact identifier application number: M017
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier application number: M017
Liprotek	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5	2023-10-19	Warnings	Exact identifier application number: M017
GENUINE FIRST AID Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bc7c6739-6068-4694-adc9-0c0c5c347df4	2023-10-19	Warnings	Exact identifier application number: M017
CVS Itch relief moisturizing	PRAMOXINE HCL 1%	CVS Health	f3a753fc-f448-6bba-e053-2a95a90a8e1b	2023-10-18	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Asclemed USA, Inc.	e13984ea-73a9-2894-e053-2995a90a8ed6	2023-10-16	Warnings	Exact identifier application number: M017
EXOTEN-C	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Asclemed USA, Inc.	76ed37e0-64b5-4abe-a03c-3dc7084a3919	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	2023-10-16	Warnings	Exact identifier application number: M017
Calypxo HP Pain Relief	METHYL SALICYLATE, MENTHOL	Asclemed USA, Inc	89a8c267-bd92-4d0d-8e50-c52224aff9cd	2023-10-16	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Whitestone Products LLC	0e32e9c0-ff5b-4e88-89b1-f5903cd98209	2023-10-16	Warnings	Exact identifier application number: M017
Capsadyn	CAPSAICIN	Chorda Pharma, Inc	07731045-0d2b-76b7-e063-6294a90af921	2023-10-11	Warnings	Exact identifier application number: M017
WHITE FLOWER STRAIN RELIEF	CAMPHOR, MENTHOL AND METHYL SALICYLATE	HOE HIN PAK FAH YEOW MANUFACTORY LTD	65282267-de63-453a-a686-f8752c71b9ef	2023-10-02	Warnings	Exact identifier application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTED	CAMPHOR, MENTHOL AND METHYL SALICYLATE	HOE HIN PAK FAH YEOW MANUFACTORY LTD	4e9cb5aa-b0aa-4a5c-b561-cc38437758d8	2023-10-02	Warnings	Exact identifier application number: M017
NATUREANCE BODY BALM	CAMPHOR	EROS GLOBAL CORP	05b84fd2-8d8f-9249-e063-6294a90ae29f	2023-09-19	Warnings	Exact identifier application number: M017
U ICE COLD	MENTHOL	UNIVERSAL DISTRIBUTION CENTER LLC	752ef0cd-f12a-3b9e-e053-2991aa0abeb1	2023-09-01	Warnings	Exact identifier application number: M017
Family Wellness Pain Relief with Lidocaine	PAIN RELIEF WITH LIDOCAINE	FAMILY DOLLAR (Family Wellness)	3a18119f-6c75-4cea-a990-97cb8a9589d4	2023-08-29	Warnings	Exact identifier application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain Relief	LIDOCAINE	WellSpring Pharmaceutical Corporation	71300df9-6113-4f25-93ca-28ad7e7f79de	2023-06-08	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010769	lidocaine HCl 2 % Topical Spray	PSN	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2
1010769	lidocaine hydrochloride 20 MG/ML Topical Spray	SCD	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2
1010769	lidocaine hydrochloride 2 % Topical Spray	SY	b6f288f7-9ae3-215e-e053-2a95a90aedf6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78495-142-01	78495014201	59.1 mL in 1 BOTTLE, PUMP (78495-142-01)	59.1 ml	2020-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
78495-142 MEDI-FIRST Topical Analgesic	Ultra Distributors Inc \| Nantong Health & Beyond Hygienic Products Inc.	2026-09-07	HUMAN OTC DRUG LABEL	3