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 68 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	7560c80b-8952-4748-af3a-20e3d4255695	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Derma-Caine Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCL	Unifirst First Aid Corporation	67629392-7e02-321a-e053-2991aa0a0f24	2025-09-08	Warnings	Exact identifier application number: M003
Medi-First Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b3ef1ef5-1f6f-874a-e053-2995a90a32b1	2025-09-08	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	a0f58025-2c50-45dc-94db-cacbd4cf604c	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Alcohol Wipes	ISOPROPYL ALCOHOL	Unifirst First Aid Corporation	ce6992d8-037f-61c7-e053-2a95a90ad0b0	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antimicrobial Towelettes	ETHYL ALCOHOL 66.5%	Unifirst First Aid Corporation	6e5ddc39-f1f1-f2dd-e053-2991aa0aa9c5	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Antiseptic	BENZALKONIUM CHLORIDE	Unifirst First Aid Corporation	b4627f3f-6282-51bf-e053-2a95a90a3d59	2025-09-08	Warnings	Exact identifier application number: M003
Green Guard Hydrogen Peroxide	HYDROGEN PEROXIDE	Unifirst First Aid Corporation	b463d09c-4b33-3774-e053-2a95a90a046b	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Burn Cream with Lidocain	BENZALKONIUM CHLORIDE, LIDOCAINE	Thompson Safety	11729e6b-b911-5c1f-e063-6394a90a0c34	2025-09-08	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ALCOHOL GEL	Thompson	06beaf35-f814-bf9b-e063-6294a90aec8c	2025-09-08	Warnings	Exact identifier application number: M003
Smart Care Kids Hand Sanitizer Barbie	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e41580a-64c5-480f-e063-6294a90a4bf1	2025-09-07	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	2869cb20-9cd4-54f5-e063-6294a90a5fea	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	28694168-3362-de4f-e063-6394a90a2e35	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Cucumber Melon Hand Sanitizer	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e0a5382-7b58-fd6e-e063-6394a90abf66	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3e09c0aa-0241-0816-e063-6294a90a481e	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3080d8a2-a780-e79b-e063-6294a90ac654	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3081e1b5-66b4-77a8-e063-6394a90a8dd3	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	30847dd5-e378-1a35-e063-6294a90a43da	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3084d980-29ca-91ca-e063-6294a90a6c67	2025-09-05	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 3pk 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	3099e6af-8072-d26b-e063-6394a90a39ef	2025-09-05	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