CAL-SHINE ANTISEPTIC HAND SANITIZER

Product NDC: 78604-646
11-digit product format: 786040646
Labeler code: 78604
Product ID: 78604-646_3f54e374-3eef-4e66-8d52-aace004432c5
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: California Shine Construction
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-10
Marketing end: 0000-00-00
Substance: ISOPROPYL ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2024-12-31
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	78604-646		I	Inactivated by FDA	2026-10-02
excluded package	package	78604-646	78604-646-11	I	Inactivated by FDA	2026-10-02
excluded package	package	78604-646	78604-646-23	I	Inactivated by FDA	2026-10-02
excluded package	package	78604-646	78604-646-37	I	Inactivated by FDA	2026-10-02
excluded package	package	78604-646	78604-646-47	I	Inactivated by FDA	2026-10-02
excluded package	package	78604-646	78604-646-60	I	Inactivated by FDA	2026-10-02

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 2 · 66 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	78604-646-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78604-646-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78604-646-47	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78604-646-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78604-646-60	`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	78604-646-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78604-646-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78604-646-47	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78604-646-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78604-646-60	`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	78604-646-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78604-646-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78604-646-47	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78604-646-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78604-646-60	`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	78604-646-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78604-646-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78604-646-47	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78604-646-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78604-646-60	`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	78604-646-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78604-646-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78604-646-47	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78604-646-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78604-646-60	`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	78604-646-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78604-646-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78604-646-47	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78604-646-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78604-646-60	`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	78604-646-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78604-646-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78604-646-47	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78604-646-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78604-646-60	`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 package	package	78604-646-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78604-646-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78604-646-47	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78604-646-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78604-646-60	`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 package	package	78604-646-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78604-646-37	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78604-646-47	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78604-646-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78604-646-60	`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 package	package	78604-646-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78604-646-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78604-646-47	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78604-646-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78604-646-60	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
78604-646-11	2024-07-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-23	2024-07-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-37	2024-07-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-47	2024-07-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-60	2024-07-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-11	2024-01-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-23	2024-01-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-37	2024-01-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-47	2024-01-30	CAL-SHINE ANTISEPTIC HAND SANITIZER
78604-646-60	2024-01-30	CAL-SHINE ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78604-646-11	CAL-SHINE ANTISEPTIC HAND SANITIZER	118 mL in 1 BOTTLE	LIQUID	118	4
78604-646-23	CAL-SHINE ANTISEPTIC HAND SANITIZER	237 mL in 1 BOTTLE	LIQUID	237	4
78604-646-37	CAL-SHINE ANTISEPTIC HAND SANITIZER	3785 mL in 1 BOTTLE	LIQUID	3785	4
78604-646-47	CAL-SHINE ANTISEPTIC HAND SANITIZER	474 mL in 1 BOTTLE	LIQUID	474	4
78604-646-60	CAL-SHINE ANTISEPTIC HAND SANITIZER	60 mL in 1 BOTTLE	LIQUID	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78604-646	CAL-SHINE ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [CALIFORNIA SHINE CONSTRUCTION]	4	Legacy NDC, 5 package rows	20230113_45489785-2228-4bf7-83c0-9160e357cffc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039900	isopropyl alcohol 75 % Topical Solution	PSN	45489785-2228-4bf7-83c0-9160e357cffc	4
1039900	isopropyl alcohol 0.75 ML/ML Topical Solution	SCD	45489785-2228-4bf7-83c0-9160e357cffc	4
1039900	isopropyl alcohol 75 % Topical Solution	SY	45489785-2228-4bf7-83c0-9160e357cffc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78604-646-11	78604064611	118 mL in 1 BOTTLE (78604-646-11)	118 ml	2020-06-10	0000-00-00	No	No	Current
78604-646-23	78604064623	237 mL in 1 BOTTLE (78604-646-23)	237 ml	2020-06-10	0000-00-00	No	No	Current
78604-646-37	78604064637	3785 mL in 1 BOTTLE (78604-646-37)	3785 ml	2020-06-10	0000-00-00	No	No	Current
78604-646-47	78604064647	474 mL in 1 BOTTLE (78604-646-47)	474 ml	2020-06-10	0000-00-00	No	No	Current
78604-646-60	78604064660	60 mL in 1 BOTTLE (78604-646-60)	60 ml	2020-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CAL-SHINE ANTISEPTIC HAND SANITIZER	California Shine Construction	2023-01-12	HUMAN OTC DRUG LABEL	4