Hand Sanitizer

Product NDC: 78614-435
11-digit product format: 786140435
Labeler code: 78614
Product ID: 78614-435_a706164d-fa68-82a4-e053-2a95a90a06ae
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Hidden Springs Manufacturing LLC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78614-435		I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-10	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-16	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-28	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-30	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-50	I	Inactivated by FDA	2026-10-05
excluded package	package	78614-435	78614-435-64	I	Inactivated by FDA	2026-10-05

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 3 · 162 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78614-435-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78614-435-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78614-435-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78614-435-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78614-435-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78614-435-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78614-435-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78614-435-64	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78614-435-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78614-435-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78614-435-10	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78614-435-04	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-08	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-10	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-16	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-28	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-30	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-50	a706164d-fa79-82a4-e053-2a95a90a06ae
78614-435-64	a706164d-fa79-82a4-e053-2a95a90a06ae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78614-435-04	Hand Sanitizer	118 mL in 1 BOTTLE, PLASTIC	GEL	118	1
78614-435-08	Hand Sanitizer	236.59 mL in 1 BOTTLE, PUMP	GEL	236.59	1
78614-435-10	Hand Sanitizer	10 mL in 1 BOTTLE, SPRAY	GEL	10	1
78614-435-16	Hand Sanitizer	473 mL in 1 BOTTLE, PLASTIC	GEL	473	1
78614-435-28	Hand Sanitizer	3785.41 mL in 1 BOTTLE, PLASTIC	GEL	3785.41	1
78614-435-30	Hand Sanitizer	30 mL in 1 TUBE	GEL	30	1
78614-435-50	Hand Sanitizer	50 mL in 1 BOTTLE, PLASTIC	GEL	50	1
78614-435-64	Hand Sanitizer	1892.71 mL in 1 BOTTLE, PUMP	GEL	1892.71	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78614-435	HAND SANITIZER (ALCOHOL) GEL [HIDDEN SPRINGS MANUFACTURING LLC.]	1	Legacy NDC, 8 package rows	20200709_a706164d-fa79-82a4-e053-2a95a90a06ae.zip

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	a706164d-fa79-82a4-e053-2a95a90a06ae	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a706164d-fa79-82a4-e053-2a95a90a06ae	1
581662	ethanol 70 % Topical Gel	SY	a706164d-fa79-82a4-e053-2a95a90a06ae	1
581662	ethyl alcohol 70 % Topical Gel	SY	a706164d-fa79-82a4-e053-2a95a90a06ae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78614-435-04	78614043504	118 mL in 1 BOTTLE, PLASTIC (78614-435-04)	118 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-08	78614043508	236.59 mL in 1 BOTTLE, PUMP (78614-435-08)	236.59 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-10	78614043510	10 mL in 1 BOTTLE, SPRAY (78614-435-10)	10 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-16	78614043516	473 mL in 1 BOTTLE, PLASTIC (78614-435-16)	473 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-28	78614043528	3785.41 mL in 1 BOTTLE, PLASTIC (78614-435-28)	3785.41 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-30	78614043530	30 mL in 1 TUBE (78614-435-30)	30 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-50	78614043550	50 mL in 1 BOTTLE, PLASTIC (78614-435-50)	50 ml	2020-03-30	0000-00-00	No	No	Current
78614-435-64	78614043564	1892.71 mL in 1 BOTTLE, PUMP (78614-435-64)	1892.71 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALCOHOL - Hidden Springs Manufacturing LLC. \| HIDDEN SPRINGS MFG., CO. LLC	Hidden Springs Manufacturing LLC. \| HIDDEN SPRINGS MFG., CO. LLC	2020-06-01	HUMAN OTC DRUG LABEL	1