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 47 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic wipe	BENZALKONIUM CHLORIDE	Yiwu Ori-Power Medtech Co.,Ltd.	fc4fc127-3130-4891-b390-6dc823cb30d4	2026-01-01	Warnings	Exact identifier application number: M003
Iodine Prep Pad Antiseptic	POVIDONE-IODINE	Yiwu Ori-Power Medtech Co.,Ltd.	0fdded64-4e89-d28c-e063-6394a90a7b8f	2026-01-01	Warnings	Exact identifier application number: M003
OP First Aid Series Alcohol Prep Pad	ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co., Ltd.	b3da7cff-4555-358e-e053-2995a90ae0ff	2026-01-01	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Astera International LLC	a5189240-19ce-7715-e053-2995a90ad043	2025-12-31	Warnings	Exact identifier application number: M003
Water Jel Hydrogen Peroxide	HYDROGEN PEROXIDE	Water-Jel Technologies	f508c3cb-e162-4d11-9513-ff44918f82c0	2025-12-31	Warnings	Exact identifier application number: M003
HEB 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	HEB Grocery Company	e8dd7f84-3690-4ab3-a21f-43bf66984f4b	2025-12-30	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	HAIAN KANGRUI TEXTILE CO., LTD.	4711fb91-8afd-e5db-e063-6394a90a4b9e	2025-12-29	Warnings	Exact identifier application number: M003
Antiseptic	BENZETHONIUM CHLORIDE	MPM Medical, LLC	3f660269-f83d-4f71-9a70-e2ddb2c57ec6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizing Spry	HAND SANITIZER SPRAY	SnugZ/USA, LLC	9391bc26-57e6-daec-e053-2995a90a1eb6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Beaded Hand Sanitizer Gel	BEADED HAND SANITIZER GEL	SnugZ/USA, LLC	6deb1142-dfba-a72b-e053-2991aa0aba43	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizer Gel	HAND SANITIZER GEL	SnugZ/USA, LLC	69bc7a80-0898-4c08-e053-2a91aa0a87a9	2025-12-29	Warnings	Exact identifier application number: M003
Englewood Mesh Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	a737fe63-6285-41ee-9516-9c3030a0ab48	2025-12-29	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	4710c90b-ce88-b0b8-e063-6294a90a3860	2025-12-28	Warnings	Exact identifier application number: M003
Freshnap Plus - 80% Ethyl Alcohol Towelette	ALCOHOL TOWELETTE	KARI-OUT LLC	f4ae66e3-323b-5e2e-e053-2995a90acf42	2025-12-27	Warnings	Exact identifier application number: M003
Guardelle	BENZALKONIUM CHLORIDE	Social Medical Supply LLC	8793e3be-7409-4f71-9397-abbeacd27cf8	2025-12-22	Warnings	Exact identifier application number: M003
CareALL First Aid Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	New World Imports, Inc	69eef888-0044-485c-96a1-247ed1204858	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Pear Blossom Tea	ALCOHOL SOLUTION	Noshinku	46927edb-f8be-f0b9-e063-6294a90a8e56	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Santal Blanc	ALCOHOL SOLUTION	Noshinku	4692c807-268e-6477-e063-6394a90aac0a	2025-12-22	Warnings	Exact identifier application number: M003
Hand Sanitizer Vanilla Creme	ALCOHOL SOLUTION	Noshinku	4692e68c-2bc8-83f8-e063-6294a90a84e4	2025-12-22	Warnings	Exact identifier application number: M003
Alcohol sanitizer wipes	ALCOHOL/PURIFIED WATER	SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.	ab9634bd-4226-2f73-e053-2995a90a802f	2025-12-19	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