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 90 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol Extra-Thick	ISOPROPYL ALCOHOL	Meijer Distribution Inc	0b02643d-ea14-4877-ae9c-f0749d1b2d10	2025-01-03	Warnings	Exact identifier application number: M003
Premier Value	ISOPROPYL ALCOHOL	Pharmacy Value Alliance, LLC	d2baa47e-9673-7f23-e053-2a95a90adcb7	2025-01-03	Warnings	Exact identifier application number: M003
CVS Alcohol Prep	ISOPROPYL ALCOHOL	CVS Pharmacy	88f761c1-cb50-4edc-9a54-43444378eff7	2025-01-03	Warnings	Exact identifier application number: M003
Sterile Alcohol	ISOPROPYL ALCOHOL	Chain Drug Marketing Association Inc	55922632-3768-4450-9389-ba7d7d91f2c9	2025-01-03	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CASAD Company, Inc	1e314157-c64e-492a-89ad-2b28831d551d	2025-01-03	Warnings	Exact identifier application number: M003
Betadine	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	00002127-02bc-4c66-b0c3-ca29d8224afc	2025-01-02	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDY	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d02e4d6-8751-b5bc-e063-6394a90a9d97	2025-01-01	Warnings	Exact identifier application number: M003
COVISIDE HAND SANITIZER	ISOPROPYL ALCOHOL	CREAGEN INC	a9f07fcd-4d5c-362c-e053-2a95a90a2e79	2024-12-30	Warnings	Exact identifier application number: M003
KEEPAN A	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	a30679d5-5507-499d-9d9f-498095fd32ac	2024-12-30	Warnings	Exact identifier application number: M003
DE LA CRUZ GENTIAN VIOLET	GENTIAN VIOLET	DLC Laboratories, Inc.	d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a7	2024-12-30	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	R&C Imports LLC	4e3fe418-d1d9-3024-e054-00144ff88e88	2024-12-27	Warnings	Exact identifier application number: M003
terrasil First Aid Antiseptic Wound and Burn Care	HEXYLRESORCINOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2d81c9-5a9f-bb72-e063-6294a90aaf18	2024-12-26	Warnings	Exact identifier application number: M003
ABOVE INTIMATE LIQUIDSOAP	ABOVE INTIMATE	BASTON INDUSTRIA DE AEROSSOIS LTDA	02f37e55-72fb-532b-e063-6394a90ab0c3	2024-12-26	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING	BENZALKONIUM	MY IMPORTS USA LLC	2a23da19-aca0-6d86-e063-6394a90ad52e	2024-12-25	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	2a23ed29-20c3-ab51-e063-6394a90a13a2	2024-12-25	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ADVANCED SANITIZER ETHYL ALCOHOL	ETHYL ALCOHOL	MY IMPORTS USA LLC	2a24bfc4-cf6e-29a4-e063-6394a90afa78	2024-12-25	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING	BENZALKONIUM	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	29ff1d68-06f7-e133-e063-6294a90a6154	2024-12-24	Warnings	Exact identifier application number: M003
MedBox Hand Sanitizer	ALCOHOL	Harpers Pharmacy, Inc.	f66c6abe-161c-48fa-8736-0abf97c3799a	2024-12-20	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE 10%	Trifecta Pharmaceuticals USA LLC	f80ccd8a-9b9b-bbf9-e053-6394a90ac827	2024-12-20	Warnings	Exact identifier application number: M003
All Good Rose Geranium Hand Sanitizer	ETHYL ALCOHOL	Elemental Herbs, Inc.	f9b93df2-e28d-840e-e053-6294a90ae48a	2024-12-20	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