SunDrops 87

Product NDC: 63621-387
11-digit product format: 636210387
Labeler code: 63621
Product ID: 63621-387_435389b8-9dde-0d17-e063-6294a90ab9b8
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SOAP
Route: TOPICAL
Labeler: Sunburst Chemicals, Inc.
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-08
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	63621-387	63621-387-14	D	Discontinued by firm		2026-08-07

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 · 12 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: SunDrops 87
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1 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
1233282	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
584ea129-aaf2-402f-b9f1-3fec2a23a21c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63621-387-14	SunDrops 87	3785 mL in 1 BOTTLE, PLASTIC	SOAP	3785	8
63621-387-40	SunDrops 87	1000 mL in 1 BAG	SOAP	1000	8
63621-387-40	SunDrops 87	4 in 1 BOX	SOAP	4	8
63621-387-50	SunDrops 87	500 mL in 1 BOTTLE, PUMP	SOAP	500	8
63621-387-50	SunDrops 87	6 in 1 BOX	SOAP	6	8
63621-387-65	SunDrops 87	8 in 1 BOX	SOAP	8	8
63621-387-65	SunDrops 87	1000 mL in 1 BAG	SOAP	1000	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63621-387	SUNDROPS 87 (BENZALKONIUM CHLORIDE) SOAP [SUNBURST CHEMICALS, INC.]	7	Current NDC, Legacy NDC, 7 package rows	20250117_584ea129-aaf2-402f-b9f1-3fec2a23a21c.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
SunDrops 87	BENZALKONIUM CHLORIDE	Sunburst Chemicals, Inc.	584ea129-aaf2-402f-b9f1-3fec2a23a21c	2025-11-11	Warnings	Exact identifier ndc (product): 63621-387

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
1233282	benzalkonium chloride 0.1 % Medicated Liquid Soap	PSN	584ea129-aaf2-402f-b9f1-3fec2a23a21c	8
1233282	benzalkonium chloride 1 MG/ML Medicated Liquid Soap	SCD	584ea129-aaf2-402f-b9f1-3fec2a23a21c	8
1233282	benzalkonium chloride 0.1 % Medicated Liquid Soap	SY	584ea129-aaf2-402f-b9f1-3fec2a23a21c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63621-387-14	63621038714	3785 mL in 1 BOTTLE, PLASTIC (63621-387-14)	3785 ml	2020-06-08	0000-00-00	No	No	Current
63621-387-40	63621038740	4 BAG in 1 BOX (63621-387-40) / 1000 mL in 1 BAG	4 bag	2025-10-16		No	No	Current
63621-387-50	63621038750	6 BOTTLE, PUMP in 1 BOX (63621-387-50) / 500 mL in 1 BOTTLE, PUMP		2020-06-08	0000-00-00	No	No	Current
63621-387-65	63621038765	8 BAG in 1 BOX (63621-387-65) / 1000 mL in 1 BAG	8 bag	2020-07-14	0000-00-00	No	No	Current