Purevita 80% Hand Sanitizer Gel

Product NDC: 78677-800
11-digit product format: 786770800
Labeler code: 78677
Product ID: 78677-800_a865d212-caed-6388-e053-2a95a90a4563
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Davita Chemicals, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-07
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 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 · 17 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78677-800		I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-02	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-04	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-06	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-08	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-10	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-12	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-16	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-24	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-32	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-64	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-70	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-71	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-73	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-75	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-83	I	Inactivated by FDA	2026-10-12
excluded package	package	78677-800	78677-800-99	I	Inactivated by FDA	2026-10-12

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 6 · 306 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	78677-800-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-73	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78677-800-08	`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	78677-800-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-73	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78677-800-08	`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	78677-800-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-73	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78677-800-08	`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	78677-800-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78677-800-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
78677-800-02	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-04	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-06	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-08	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-10	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-12	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-16	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-24	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-32	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-64	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-70	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-71	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-73	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-75	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-83	a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-99	a710ef17-cbde-5e97-e053-2a95a90a65bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78677-800-02	Purevita 80% Hand Sanitizer Gel	59 mL in 1 BOTTLE, DISPENSING	GEL	59	2
78677-800-04	Purevita 80% Hand Sanitizer Gel	118 mL in 1 BOTTLE, DISPENSING	GEL	118	2
78677-800-06	Purevita 80% Hand Sanitizer Gel	177 mL in 1 BOTTLE, DISPENSING	GEL	177	2
78677-800-08	Purevita 80% Hand Sanitizer Gel	236 mL in 1 BOTTLE, DISPENSING	GEL	236	2
78677-800-10	Purevita 80% Hand Sanitizer Gel	295 mL in 1 BOTTLE, DISPENSING	GEL	295	2
78677-800-12	Purevita 80% Hand Sanitizer Gel	354 mL in 1 BOTTLE, DISPENSING	GEL	354	2
78677-800-16	Purevita 80% Hand Sanitizer Gel	473 mL in 1 BOTTLE, DISPENSING	GEL	473	2
78677-800-24	Purevita 80% Hand Sanitizer Gel	709 mL in 1 BOTTLE, DISPENSING	GEL	709	2
78677-800-32	Purevita 80% Hand Sanitizer Gel	946 mL in 1 BOTTLE, DISPENSING	GEL	946	2
78677-800-64	Purevita 80% Hand Sanitizer Gel	1892 mL in 1 BOTTLE, DISPENSING	GEL	1892	2
78677-800-70	Purevita 80% Hand Sanitizer Gel	3785 mL in 1 JUG	GEL	3785	2
78677-800-71	Purevita 80% Hand Sanitizer Gel	3785 mL in 1 BOX, UNIT-DOSE	GEL	3785	2
78677-800-73	Purevita 80% Hand Sanitizer Gel	11356 mL in 1 DRUM	GEL	11356	2
78677-800-75	Purevita 80% Hand Sanitizer Gel	208198 mL in 1 DRUM	GEL	208198	2
78677-800-83	Purevita 80% Hand Sanitizer Gel	124919 mL in 1 DRUM	GEL	124919	2
78677-800-99	Purevita 80% Hand Sanitizer Gel	2271247 mL in 1 TANK	GEL	2271247	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78677-800	PUREVITA 80% HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [DAVITA CHEMICALS, LLC]	2	Legacy NDC, 16 package rows	20200619_a710ef17-cbde-5e97-e053-2a95a90a65bd.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
1041498	ethanol 80 % Topical Gel	PSN	a710ef17-cbde-5e97-e053-2a95a90a65bd	2
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a710ef17-cbde-5e97-e053-2a95a90a65bd	2
1041498	ethanol 80 % Topical Gel	SY	a710ef17-cbde-5e97-e053-2a95a90a65bd	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78677-800-02	78677080002	59 mL in 1 BOTTLE, DISPENSING (78677-800-02)	59 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-04	78677080004	118 mL in 1 BOTTLE, DISPENSING (78677-800-04)	118 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-06	78677080006	177 mL in 1 BOTTLE, DISPENSING (78677-800-06)	177 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-08	78677080008	236 mL in 1 BOTTLE, DISPENSING (78677-800-08)	236 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-10	78677080010	295 mL in 1 BOTTLE, DISPENSING (78677-800-10)	295 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-12	78677080012	354 mL in 1 BOTTLE, DISPENSING (78677-800-12)	354 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-16	78677080016	473 mL in 1 BOTTLE, DISPENSING (78677-800-16)	473 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-24	78677080024	709 mL in 1 BOTTLE, DISPENSING (78677-800-24)	709 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-32	78677080032	946 mL in 1 BOTTLE, DISPENSING (78677-800-32)	946 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-64	78677080064	1892 mL in 1 BOTTLE, DISPENSING (78677-800-64)	1892 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-70	78677080070	3785 mL in 1 JUG (78677-800-70)	3785 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-71	78677080071	3785 mL in 1 BOX, UNIT-DOSE (78677-800-71)	3785 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-73	78677080073	11356 mL in 1 DRUM (78677-800-73)	11356 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-75	78677080075	208198 mL in 1 DRUM (78677-800-75)	208198 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-83	78677080083	124919 mL in 1 DRUM (78677-800-83)	124919 ml	2020-03-07	0000-00-00	No	No	Current
78677-800-99	78677080099	2271247 mL in 1 TANK (78677-800-99)	2271247 ml	2020-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Purevita 80% Hand Sanitizer Gel - Davita Chemicals, LLC	Davita Chemicals, LLC	2020-06-18	HUMAN OTC DRUG LABEL	2