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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BLT 2	LIDOCAINE HCL	CENTURA PHARMACEUTICALS INC	41dc85ec-d79b-0a32-e054-00144ff8d46c	2026-01-12	Warnings	Exact identifier application number: M017
Mineral Ice Pain Relieving	MENTHOL	Crown Laboratories	7b30076a-0af6-2f74-e053-2a91aa0ae08d	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE	Crown Laboratories	19b0ce1b-e147-01a1-e063-6394a90af808	2026-01-12	Warnings	Exact identifier application number: M017
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	HY-VEE, INC	48350b54-8d9a-48c4-e063-6394a90ac040	2026-01-12	Warnings	Exact identifier application number: M017
LidoPlus Pain Relief	LIDOCAINE HYDROCHLORIDE	Centura Pharmaceuticals, Inc	07bacc6c-60a6-4297-8663-904a22bdc040	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier application number: M017
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f2277e27-868b-57ef-e053-2a95a90abf28	2026-01-12	Warnings	Exact identifier application number: M017
BLT 3	TETRACAINE	CENTURA PHARMACEUTICALS INC	401a0d22-1181-02ac-e054-00144ff88e88	2026-01-12	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	0c901f64-6890-45c0-9ca7-ee9de87903c4	2026-01-12	Warnings	Exact identifier application number: M017
Goodsense Oral Pain Relief	BENZOCAINE	Geiss, Destin and Dunn, Inc.	eb461b70-d10f-4e11-8374-e43713f3504d	2026-01-12	Warnings	Exact identifier application number: M017
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier application number: M017
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier application number: M017
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier application number: M017
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier application number: M017
DG Health Pain Relieving	LIDOCAINE HCL	DOLGENCORP, LLC	923aeb4c-049f-4ecc-a77e-9ffa0e236d4e	2026-01-11	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare	46b84e0b-78a9-4cde-9f90-e165b5419162	2026-01-09	Warnings	Exact identifier application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-On	MENTHOL	Inspec Solutions	12ff9b9a-73e5-ce31-e063-6294a90aeaf8	2026-01-09	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bb0278c9-eaff-d435-e053-2995a90a202a	2026-01-09	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