SprinJene

Product NDC: 63404-0720
Requested package NDC: 63404-0720-2
11-digit product format: 634040720
Labeler code: 63404
Product ID: 63404-0720_6a6f35e1-8954-4348-842c-1b9bcc500228
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Health and Natural Beauty USA Corp
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-08-01
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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: SprinJene
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581662	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
1853f023-f4db-4cd8-a4df-a439bc306cc3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
63404-0720-1	SprinJene ®
63404-0720-1	SprinJene ®
63404-0720-2	SprinJene ®
63404-0720-2	SprinJene ®
63404-0720-3	SprinJene ®
63404-0720-3	SprinJene ®
63404-0720-4	SprinJene ®
63404-0720-4	SprinJene ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63404-0720-1	SprinJene	500 mL in 1 BOTTLE, PUMP	GEL	500	1
63404-0720-2	SprinJene	300 mL in 1 BOTTLE, PUMP	GEL	300	1
63404-0720-3	SprinJene	250 mL in 1 BOTTLE, PUMP	GEL	250	1
63404-0720-4	SprinJene	80 mL in 1 BOTTLE, PUMP	GEL	80	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63404-0720	SPRINJENE (ALCOHOL) GEL [HEALTH AND NATURAL BEAUTY USA CORP]	1	Current NDC, Legacy NDC, 4 package rows	20200801_1853f023-f4db-4cd8-a4df-a439bc306cc3.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 61 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Lift Antibacterial Body Wash	BENZALKONIUM CHLORIDE	Spa de Soleil	ab9dde33-1bd2-062f-e053-2a95a90a4d18	2025-10-10	Warnings	Exact identifier application number: M003
Dr Lift Antibacterial	BENZALKONIUM CHLORIDE	Spa de Soleil	af89675e-e66f-0922-e053-2995a90ab9d2	2025-10-10	Warnings	Exact identifier application number: M003
ANTISEPTIC WIPE 01	BENZALKONIUM CHLORIDE	Total Resources International Inc.	cf4a6a97-529e-7f11-e053-2a95a90a75a9	2025-10-10	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Sting Relief Wipe	ALCOHOL, LIDOCAINE HYDROCHLORIDE	Total Resources International, Inc	fff6f057-739e-40f1-8427-e1364c65af05	2025-10-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Zhejiang Hudson Import& Export Co., Ltd	40b6c96c-e36f-6588-e063-6394a90adb46	2025-10-09	Warnings	Exact identifier application number: M003
Curad	ISOPROPYL ALCOHOL	Medline Industries, LP	c42de981-4e3f-1ac9-e053-2995a90aea98	2025-10-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Avaria Health & Beauty Corp	a3d87ef6-752b-b54b-e053-2a95a90af963	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice BZK Antiseptic	BENZALKONIUM CHLORIDE	O&M HALYARD, INC.	82a7710d-a9fa-4f68-8322-046a765ae929	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice Cleansing	BENZALKONIUM CHLORIDE	O&M HALYARD, INC.	79d41cf0-301f-44d4-a76c-f4850c7ddce9	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	O&M HALYARD, INC.	8b84c8ed-040e-4c07-94cb-d5bdda744648	2025-10-08	Warnings	Exact identifier application number: M003
MediChoice of Hydrogen Peroxide 3 10 Volume	HYDROGEN PEROXIDE	O&M HALYARD, INC.	34e77ef4-297d-4362-8f6e-abf80158b7f0	2025-10-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	O&M HALYARD, INC.	0ad5990a-a18d-4753-826b-6da313926698	2025-10-08	Warnings	Exact identifier application number: M003
equate Swabsticks	ISOPROPYL ALCOHOL	Walmart Inc.	cd4a4490-bb02-436d-853b-f73261d358c6	2025-10-07	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Foodhold USA	1e897ee5-17e3-459e-88e3-d7436ee22f37	2025-10-07	Warnings	Exact identifier application number: M003
Liquid Bandage	BENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDE	Premier Brands of America Inc.	051b68f9-5d6c-3cd7-e063-6394a90aeb35	2025-10-07	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	HEB	40b71196-a2ac-4a44-8046-c448d066baa2	2025-10-07	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	AmerisourceBergen Drug Corporation	5c82c4db-258e-4647-aec9-1c4520e0468a	2025-10-07	Warnings	Exact identifier application number: M003
Premier Solutions Liquid Bandage	BENZETHONIUM CHLORIDE DYCLONINE HYDROCHLORIDE	Premier Brands of America, Inc.	e196d4c2-a93e-a03c-e053-2995a90a3ea3	2025-10-07	Warnings	Exact identifier application number: M003
Liquid Bandage	BENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDE	WinCo Foods LLC	15d855fe-491e-4982-e063-6394a90aea1d	2025-10-07	Warnings	Exact identifier application number: M003
LOCKE TEDDY	ALCOHOL ANTISEPTIC	KINGKEY MBC LIFE TECHNOLOGY GROUP CO.,LTD	7c0056c1-3add-49f6-8816-b61a7f5a0508	2025-10-07	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581662	ethanol 70 % Topical Gel	PSN	1853f023-f4db-4cd8-a4df-a439bc306cc3	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	1853f023-f4db-4cd8-a4df-a439bc306cc3	1
581662	ethanol 70 % Topical Gel	SY	1853f023-f4db-4cd8-a4df-a439bc306cc3	1
581662	ethyl alcohol 70 % Topical Gel	SY	1853f023-f4db-4cd8-a4df-a439bc306cc3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63404-0720-2	63404072002	300 mL in 1 BOTTLE, PUMP (63404-0720-2)	300 ml	2020-08-01	0000-00-00	No	No	Current