aramark Antiseptic

Product NDC: 81238-5300
Requested package NDC: 81238-5300-1
11-digit product format: 812385300
Labeler code: 81238
Product ID: 81238-5300_47541f74-f1b1-43d1-908c-256117a8bdf5
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE, BENZOCAINE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Western First Aid Safety DBA Aramark
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-05-24
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength: 1 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	81238-5300	81238-5300-1	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81238-5300-1	2023-01-30	C162847	48780-1	f386c649-bb7c-0266-e053-dadaa90a7c1a	aramark Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81238-5300-1	aramark Antiseptic	59.1 mL in 1 BOTTLE, SPRAY	SPRAY	59.1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81238-5300	ARAMARK ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [WESTERN FIRST AID SAFETY DBA ARAMARK]	2	Legacy NDC, 1 package rows	20210528_d9018fe1-4255-4d4f-94f4-022d85448072.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245229	benzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray	PSN	d9018fe1-4255-4d4f-94f4-022d85448072	2
1245229	benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray	SCD	d9018fe1-4255-4d4f-94f4-022d85448072	2
1245229	benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray	SY	d9018fe1-4255-4d4f-94f4-022d85448072	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81238-5300-1	81238530001	59.1 mL in 1 BOTTLE, SPRAY (81238-5300-1)	59.1 ml	2021-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
aramark Antiseptic Spray	Western First Aid Safety DBA Aramark \| Safetec of America, Inc.	2021-05-26	HUMAN OTC DRUG LABEL	2