Berkley Jensen

Product NDC: 68391-167
11-digit product format: 683910167
Labeler code: 68391
Product ID: 68391-167_6969bdb6-7dd0-4a54-af1c-7b9de38c5515
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: BJWC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-05-27
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 650 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68391-167		I	Inactivated by FDA	2026-10-05
excluded product	product	68391-167		I	Inactivated by FDA	2026-10-05
excluded package	package	68391-167	68391-167-03	I	Inactivated by FDA	2026-10-05
excluded package	package	68391-167	68391-167-13	I	Inactivated by FDA	2026-10-05
excluded package	package	68391-167	68391-167-02	I	Inactivated by FDA	2026-10-05
excluded package	package	68391-167	68391-167-12	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 · 126 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68391-167-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68391-167-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68391-167-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68391-167-12	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68391-167-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68391-167-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68391-167-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68391-167-12	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68391-167-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68391-167-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68391-167-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68391-167-12	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68391-167-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68391-167-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68391-167-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68391-167-12	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68391-167-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68391-167-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68391-167-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68391-167-12	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68391-167-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68391-167-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68391-167-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68391-167-12	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68391-167-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68391-167-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68391-167-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68391-167-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68391-167-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68391-167-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68391-167-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68391-167-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68391-167-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68391-167-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68391-167-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68391-167-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68391-167-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68391-167-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68391-167-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68391-167-12	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
68391-167-02	9d75b9d0-1a14-f424-e053-dadaa90a57ce	DRUG FACTS
68391-167-03	9d75b9d0-5fce-f424-e053-dadaa90a57ce	Drug Facts
68391-167-12	9d75b9d0-1a14-f424-e053-dadaa90a57ce	DRUG FACTS
68391-167-13	9d75b9d0-5fce-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68391-167-02	BERKLEY JENSENINSTANT SANITIZER	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59	1
68391-167-03	Berkley JensenInstant Sanitizer	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59	1
68391-167-12	BERKLEY JENSENINSTANT SANITIZER	354 mL in 1 BOTTLE, PLASTIC	LIQUID	354	1
68391-167-13	Berkley JensenInstant Sanitizer	354 mL in 1 BOTTLE, PLASTIC	LIQUID	354	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68391-167	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1	Legacy NDC, 2 package rows	20150512_bca300d1-06ca-4e4f-a07a-3afa37a4ae4a.zip
68391-167	BERKLEY JENSEN INSTANT SANITIZER (ETHYL ALCOHOL) LIQUID [BJWC]	1	Legacy NDC, 2 package rows	20170731_aaa084bb-3a38-4fea-a2f6-9301a5ce2f49.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
884783	ethanol 65 % Topical Solution	PSN	aaa084bb-3a38-4fea-a2f6-9301a5ce2f49	1
884783	ethanol 65 % Topical Solution	PSN	bca300d1-06ca-4e4f-a07a-3afa37a4ae4a	1
884783	ethanol 0.65 ML/ML Topical Solution	SCD	aaa084bb-3a38-4fea-a2f6-9301a5ce2f49	1
884783	ethanol 0.65 ML/ML Topical Solution	SCD	bca300d1-06ca-4e4f-a07a-3afa37a4ae4a	1
884783	ethanol 65 % Topical Solution	SY	aaa084bb-3a38-4fea-a2f6-9301a5ce2f49	1
884783	ethanol 65 % Topical Solution	SY	bca300d1-06ca-4e4f-a07a-3afa37a4ae4a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68391-167-02	68391016702	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
68391-167-03	68391016703	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
68391-167-12	68391016712	354 mL in 1 BOTTLE, PLASTIC	354 ml	Historical
68391-167-13	68391016713	354 mL in 1 BOTTLE, PLASTIC	354 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	BJWC \| Apollo Health and Beauty Care Inc.	2017-07-31	HUMAN OTC DRUG LABEL	1
DRUG FACTS	BJWC \| APOLLO HEALTH AND BEAUTY CARE	2015-01-14	HUMAN OTC DRUG LABEL	1