Ben E. Keith FIHS

Product NDC: 50980-207
Requested package NDC: 50980-207-12
11-digit product format: 509800207
Labeler code: 50980
Product ID: 50980-207_09c78743-cb8d-483c-a5f5-781cc220c0e2
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Ben E. Keith Foods
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-05-31
Marketing end: 2026-11-18
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Current FDA listing: Yes

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: Ben E. Keith FIHS

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
1020365	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
4ca21370-1ecf-42c6-9c32-79cf994c336b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50980-207-31	2022-06-03	C162847	48780-1	d6a99b39-48db-a426-e053-dadaa90af4c2	Drug Facts
50980-207-31	2022-01-28	C162847	48780-1	d6a99b39-48db-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50980-207-12	Ben E. Keith FIHS	1000 mL in 1 BAG	SOLUTION	1000		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50980-207	BEN E. KEITH FIHS (BENZALKONIUM CHLORIDE) SOLUTION [BEN E. KEITH FOODS]	5	Current NDC, Legacy NDC, 1 package rows	20250305_4ca21370-1ecf-42c6-9c32-79cf994c336b.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ben E. Keith FIHS	BENZALKONIUM CHLORIDE	Ben E. Keith Foods	4ca21370-1ecf-42c6-9c32-79cf994c336b	2025-03-03	Warnings	Exact identifier ndc (package): 50980-207-12 ndc (product): 50980-207 ndc11 (package): 50980020712

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
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	4ca21370-1ecf-42c6-9c32-79cf994c336b	5
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	4ca21370-1ecf-42c6-9c32-79cf994c336b	5
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	4ca21370-1ecf-42c6-9c32-79cf994c336b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50980-207-12	50980020712	1000 mL in 1 BAG (50980-207-12)	1000 ml	2016-05-31	2026-11-18	No	No	Current