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 61 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime 4X Medicated Cream	BENZOCAINE	Rite Aid	21645ed1-2dc0-223a-e063-6394a90ab021	2025-11-21	Warnings	Exact identifier application number: M017
4x Medicated Gum Cream	BENZOCAINE	Albertsons	b81a308c-9c30-0e3d-e053-2a95a90a15d2	2025-11-21	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	b0edd9d9-951f-d3dd-e053-2995a90a8d5a	2025-11-21	Warnings	Exact identifier application number: M017
Up up	LIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHES	Target Corporation	44121d40-86e1-0df6-e063-6294a90aedaf	2025-11-20	Warnings	Exact identifier application number: M017
Up up	PAIN RELIEF ADVANCED HYDROGEL PATCHES	Target Corporation	44128b70-3172-ee37-e063-6294a90a705f	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	f03090fa-f7e6-f53a-e053-2a95a90aa819	2025-11-20	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	ff073e47-3107-e17e-e053-6294a90a58fa	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	fc8a8f20-97ab-481e-e053-6394a90a3525	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF ROLL-ON 3OZ	934d4638-b47b-187d-e053-2995a90ae69d	2025-11-20	Warnings	Exact identifier application number: M017
FOOT PAIN RELIEF ROLL-ON	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	43edcea0-ab04-f368-e063-6294a90a817a	2025-11-19	Warnings	Exact identifier application number: M017
Absolut Skin Corticosoothe Anti-Itch	HYDROCORTISONE	Absolut Skin Incorporated	deb52218-9176-4aaa-a22f-b66dada6690f	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	43f3d189-f6b7-02ed-e063-6394a90afd73	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2Z	LIDOCAINE	InterMed Laboratories Private Limited	43f3e288-e828-8130-e063-6394a90a6d44	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Leader	LIDOCAINE	InterMed Laboratories Private Limited	42f06914-c8b8-ea9c-e063-6294a90a79e6	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	CAMPHOR, MENTHOL	CVS	87715662-c788-9a8d-e053-2a95a90acb53	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti Itch	CAMPHOR, MENTHOL	Walgreens	b4f47a8d-d4a6-9233-e053-2a95a90afd90	2025-11-19	Warnings	Exact identifier application number: M017
Leader Anti-Itch	CAMPHOR, MENTHOL	LEADER/Cardinal Helath 110, Inc.	9ca985c6-5017-0558-e053-2995a90a8202	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	PRAMOXINE HCL	CVS	87fc476a-5b12-7383-e053-2995a90a530b	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti-Itch	PRAMOXINE HCL	Walgreens	b5f9d1c5-891e-4377-e053-2995a90aa281	2025-11-19	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	89f5f688-856f-f2df-e053-2995a90a73cf	2025-11-19	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