MEDI-FIRST First Aid Antiseptic

Product NDC: 78495-122
11-digit product format: 784950122
Labeler code: 78495
Product ID: 78495-122_3239abbd-8033-7f52-e063-6294a90a8740
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Ultra Distributors Inc
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-19
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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	78495-122-01	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	78495-122-01	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	78495-122-01	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	78495-122-01	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	78495-122-01	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	78495-122-01	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	78495-122-01	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 First Aid Antiseptic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1039012	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
b6efaca5-49d0-b000-e053-2995a90ab9aa	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78495-122-01	2025-04-07	C162847	48780-1	2cef2736-a700-d83d-e063-dadaa90ab31f	78495-122
78495-122-01	2025-01-30	C162847	48780-1	2cef2736-a700-d83d-e063-dadaa90ab31f	78495-122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78495-122-01	MEDI-FIRST First Aid Antiseptic	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
78495-122	MEDI-FIRST FIRST AID ANTISEPTIC (BENZALKONIUM CHLORIDE) SPRAY [ULTRA DISTRIBUTORS INC]	2	Current NDC, Legacy NDC, 1 package rows	20250409_b6efaca5-49d0-b000-e053-2995a90ab9aa.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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hongo Killer	UNDECYLENIC ACID	Efficient Laboratories Inc	5c433182-0c0c-4a0a-8dd8-a14f60e52425	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole nitrate	ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY	Meijer Distribution Inc	6c2ebe17-994d-41c8-bacb-87b6a63b2db4	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL	McKesson	8dcca44a-16c7-7262-e053-2a95a90a1b23	2024-10-10	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a	2024-10-07	Warnings	Exact identifier application number: M005
Micotrin AL	TOLNAFTATE	PureTek Corporation	cc0fba1e-82c5-42fd-e053-2995a90af249	2024-10-02	Warnings	Exact identifier application number: M005
Mycozyl AL	TOLNAFTATE	PureTek Corporation	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	2024-10-02	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	f19971b1-2aeb-4c37-82b0-9525026cff7a	2024-10-02	Warnings	Exact identifier application number: M005
Micotrin AC	CLOTRIMAZOLE	PureTek Corporation	cbe4dd18-c9ef-a4e4-e053-2995a90a5289	2024-10-01	Warnings	Exact identifier application number: M005
Micotrin AP	MICONAZOLE NITRATE	PureTek Corporation	cbe3d495-cdee-2343-e053-2a95a90a5b82	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AC	CLOTRIMAZOLE	PureTek Corporation	b676d257-3cfd-7f24-e053-2995a90a546e	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AP	MICONAZOLE NITRATE	PureTek Corporation	b3c46a30-7ff2-0dc4-e053-2995a90aa571	2024-10-01	Warnings	Exact identifier application number: M005
AOSI HEALTHCARE HAND SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	59d631d0-d8ae-45a8-a7a9-26de9cc427b3	2024-09-25	Warnings	Exact identifier application number: M005
Clotrimazole 1%	CLOTRIMAZOLE	Dabur India Limited	22916978-303f-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M005
Mentholatum Heel Revival Cream	MENTHOLATUM HEEL REVIVAL CREAM	The Mentholatum Company	21b643c2-eb6e-8939-e063-6394a90aaeac	2024-09-09	Warnings	Exact identifier application number: M005
VAGISTEN-V 7 DAY	MICONAZOLE NITRATE	OPMX LLC	a5bfa501-5ae1-4434-bc31-995d0665b99e	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Tropical Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	3645359c-06a2-4b97-b982-c54e4a0b8cda	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Coastal Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	645c09dc-15a4-481f-a605-f12fb8f8e9bd	2024-09-04	Warnings	Exact identifier application number: M005
Publix Athletic Foot	CLOTRIMAZOLE 1%	PUBLIX SUPER MARKETS, INC.	d9f99680-5636-4136-a7c6-c3643339e6b4	2024-08-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL FOOT	TOLNAFTATE	Universal Distribution Center LLC	10579848-5793-4d72-ad5f-62d191c71074	2024-07-16	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf3	2024-07-02	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039012	benzalkonium chloride 0.13 % Topical Spray	PSN	b6efaca5-49d0-b000-e053-2995a90ab9aa	2
1039012	benzalkonium chloride 1.3 MG/ML Topical Spray	SCD	b6efaca5-49d0-b000-e053-2995a90ab9aa	2
1039012	benzalkonium chloride 0.13 % Topical Spray	SY	b6efaca5-49d0-b000-e053-2995a90ab9aa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78495-122-01	78495012201	59.1 mL in 1 BOTTLE, PUMP (78495-122-01)	59.1 ml	2020-12-19	0000-00-00	No	No	Current