Instant Hand Sanitizer

Product NDC: 57337-085
11-digit product format: 573370085
Labeler code: 57337
Product ID: 57337-085_2cc00367-5d1e-bf22-e063-6394a90af6d0
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International Corp.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-04-21
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 · 4 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
2025-01-20 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	57337-085-02	`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	57337-085-02	`0efc9e666f02…`	`f202fb6c5f17…`

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: Instant Hand Sanitizer
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
4e13511b-fbb3-2523-e054-00144ff88e88	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-085-01	Instant Hand Sanitizer	53 mL in 1 BOTTLE	GEL	53		4
57337-085-02	Instant Hand Sanitizer	3 in 1 BOX	GEL	3		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-085	INSTANT HAND SANITIZER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL CORP.]	4	Current NDC, Legacy NDC, 2 package rows	20250130_4e13511b-fbb3-2523-e054-00144ff88e88.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 112 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BZK Antiseptic Wipe	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	fe5eb694-4b1b-4c47-95d5-6074155c438a	2023-11-09	Warnings	Exact identifier application number: M003
Leader Alcohol 70 Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cardinal Health	4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d	2023-11-09	Warnings	Exact identifier application number: M003
BZK Cleansing Swabsticks 4 Triple	BENZALKONIUM CHLORIDE	Changzhou Maokang Medical Products Co., Ltd	52c74f75-d7ef-481b-b580-fba402d03d75	2023-11-09	Warnings	Exact identifier application number: M003
MK Alcohol Swabstick Sterile	ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	48d198f0-d505-4e45-b7c9-dd70658fd5fa	2023-11-09	Warnings	Exact identifier application number: M003
Maokang 3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Changzhou Maokang Medical Products Co., Ltd	b4b478b9-426d-4864-a64c-31de9bbf5dc3	2023-11-09	Warnings	Exact identifier application number: M003
MK Sting Relief Pads	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd	1a60dd1b-0116-42a2-a501-4f74e326a2e9	2023-11-09	Warnings	Exact identifier application number: M003
terrasil First Aid Antiseptic Wound and Burn Care Kit	HEXYLRESORCINOL	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	5ddb84e9-cdf7-4034-acd2-625f8d6e4601	2023-11-08	Warnings	Exact identifier application number: M003
Inverness Ear Piercing	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	bcec8099-939b-4cff-b388-f4046164f2d4	2023-11-08	Warnings	Exact identifier application number: M003
Hygienic Ear Care Antiseptic	BENZALKONIUM CHLORIDE	The Richline Group, Inc.	98b70f22-cd53-e61b-e053-2995a90a730d	2023-11-06	Warnings	Exact identifier application number: M003
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	Degasa, S.A. de C.V.	b4145aa4-d810-4c20-8493-311a7e222eb9	2023-11-05	Warnings	Exact identifier application number: M003
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	DEGASA SA DE CV	26bae595-6e76-4946-b98f-1aba2e69250d	2023-11-05	Warnings	Exact identifier application number: M003
Hand Sanitizer	ETHYL ALCOHOL	Raining Rose, Inc.	416267f2-85c5-6633-e054-00144ff8d46c	2023-11-03	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	70%ISOPROPYL ALCOHOL	Raya Pharmaceuticals LLC	da108e12-4327-db1c-e053-2a95a90a211b	2023-10-27	Warnings	Exact identifier application number: M003
POVIDONE-IODINE PAD- povidone-iodine swab	POVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)	Raya Pharmaceuticals LLC	dbcbd1be-5274-3de3-e053-2995a90abf1c	2023-10-27	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	4bfea435-f40d-4976-8450-a699f7640c65	2023-10-23	Warnings	Exact identifier application number: M003
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Jianerkang Medical Co., Ltd	3a32398a-3f7e-4da0-bb1d-b3f369914b2a	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0c0-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a504b8-b0af-030a-e054-00144ff88e88	2023-10-23	Warnings	Exact identifier application number: M003
BZK	BENZALKONIUM CHLORIDE	Jianerkang Medical Co., Ltd	d96c6ad2-c7e9-4079-9db2-59d108f284bb	2023-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	47a5690c-08bf-5092-e054-00144ff8d46c	2023-10-23	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	4e13511b-fbb3-2523-e054-00144ff88e88	4
581662	ethanol 0.7 ML/ML Topical Gel	SCD	4e13511b-fbb3-2523-e054-00144ff88e88	4
581662	ethanol 70 % Topical Gel	SY	4e13511b-fbb3-2523-e054-00144ff88e88	4
581662	ethyl alcohol 70 % Topical Gel	SY	4e13511b-fbb3-2523-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-085-01	57337008501	53 mL in 1 BOTTLE	53 ml					Historical
57337-085-02	57337008502	3 BOTTLE in 1 BOX (57337-085-02) / 53 mL in 1 BOTTLE (57337-085-01)	3 bottle	2017-04-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Instant Hand Sanitizer	Rejoice International Corp. \| China Ningbo Shangge Cosmetic Technology Corp.	2025-01-28	HUMAN OTC DRUG LABEL	4