First Aid Antiseptic Pain Relieving

Product NDC: 82199-610
Requested package NDC: 82199-610-26
11-digit product format: 821990610
Labeler code: 82199
Product ID: 82199-610_d11f5df7-b23a-a407-e053-2995a90a728b
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE,PRAMOXINE HYDROCHLORIDE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Shandong Ruian Pharmaceutical Co.,Ltd.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-11-19
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE
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	82199-610	82199-610-26	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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82199-610-26	2023-01-30	C162847	48780-1	f386c649-c071-0266-e053-dadaa90a7c1a	d11f5df7-b239-a407-e053-2995a90a728b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82199-610-26	First Aid Antiseptic Pain Relieving	7.7 mL in 1 VIAL	SPRAY	7.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82199-610	FIRST AID ANTISEPTIC PAIN RELIEVING (BENZALKONIUM CHLORIDE,PRAMOXINE HYDROCHLORIDE) SPRAY [SHANDONG RUIAN PHARMACEUTICAL CO.,LTD.]	1	Legacy NDC, 1 package rows	20211121_d11f5df7-b239-a407-e053-2995a90a728b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049123	benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray	PSN	d11f5df7-b239-a407-e053-2995a90a728b	1
1049123	benzalkonium chloride 1.3 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray	SCD	d11f5df7-b239-a407-e053-2995a90a728b	1
1049123	benzalkonium Cl 0.13 % / pramoxine HCl 1 % Topical Spray	SY	d11f5df7-b239-a407-e053-2995a90a728b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82199-610-26	82199061026	7.7 mL in 1 VIAL (82199-610-26)	7.7 ml	2021-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Antiseptic Pain Relieving - Shandong Ruian Pharmaceutical Co.,Ltd.	Shandong Ruian Pharmaceutical Co.,Ltd.	2021-11-19	HUMAN OTC DRUG LABEL	1