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 104 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Healing Hand Cream 2000mg	MENTHOL	Carolina Cannabis Creations LLC	01f8795b-9f95-c793-e063-6394a90a8330	2025-01-15	Warnings	Exact identifier application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5	CAMPHOR, MENTHOL	ABACUS HEALTH PRODUCTS, INC.	31e2e5cd-d33e-f058-e063-6394a90af7d2	2025-01-14	Warnings	Exact identifier application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Exact identifier application number: M017
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Exact identifier application number: M017
elp essential MANTECA DE UBRE	METHYL SALICYLATE, CAMPHOR	Miramar Cosmetics, Inc DBA Miramar Lab	c3964dfe-17fe-4d89-a4c4-cf500f982259	2025-01-13	Warnings	Exact identifier application number: M017
Methylten	METHYL SALICYLATE 10%	Puretek Corporation	28f4093f-803f-0e70-e063-6294a90a98a4	2025-01-13	Warnings	Exact identifier application number: M017
Refill Bundle 7 Large Office	BENZALKONIUM CHLORIDE	CMC Group, Inc.	6620a8f3-098d-d045-e053-2a91aa0a0d94	2025-01-13	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba1de83-494a-6c54-e063-6294a90a9b2d	2025-01-13	Warnings	Exact identifier application number: M017
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	Warnings	Exact identifier application number: M017
LABOFLEX Lidocaine Pain Relieving Patch	LIDOCAINE 4%	Laboflex, Inc.	31995f31-c272-afdb-e063-6294a90af3f9	2025-01-10	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Chain Drug Marketing Association Inc.	2b48cb2f-e6bf-f9de-e063-6394a90a42d4	2025-01-09	Warnings	Exact identifier application number: M017
PAIN-X	MENTHOL	OL PHARMA TECH,LLC	b22bb19a-14e5-3d32-e053-2a95a90ae520	2025-01-09	Warnings	Exact identifier application number: M017
MUSCLE RUB	MENTHOL	OL PHARMA TECH,LLC	b22c7999-52d5-25c3-e053-2a95a90a01f5	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	ce392c4f-cc43-484d-9c49-18fa25e4e5e9	2025-01-09	Warnings	Exact identifier application number: M017
NEW TEROCIN	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	A-S Medication Solutions	43e5eb27-5541-4b7b-80de-55a79a4dce55	2025-01-09	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