Unishield Hand Sanitizer

Product NDC: 49314-0004
11-digit product format: 493140004
Labeler code: 49314
Product ID: 49314-0004_3f97ff59-fdb2-0568-e063-6294a90a3f40
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Unishield
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-15
Substance: ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49314-0004-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49314-0004-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49314-0004-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49314-0004-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49314-0004-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49314-0004-1	U	Excluded because listing certification expired	`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: Unishield Hand Sanitizer
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	75 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
1305100	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
eae1fc97-eb39-4353-adfa-7c549d50b5db	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49314-0004-1	2025-09-24	C162847	48780-1	2cef2736-a0ef-d83d-e063-dadaa90ab31f	49314-0004 Unishield sanitizer
49314-0004-1	2025-01-30	C162847	48780-1	2cef2736-a0ef-d83d-e063-dadaa90ab31f	49314-0004 Unishield sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49314-0004-1	Unishield Hand Sanitizer	25 in 1 BOX	GEL	25		2
49314-0004-1	Unishield Hand Sanitizer	0.9 mL in 1 PACKET	GEL	0.9		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49314-0004	UNISHIELD HAND SANITIZER (ETHYL ALCOHOL) GEL [UNISHIELD]	1	Current NDC, 2 package rows	20231116_eae1fc97-eb39-4353-adfa-7c549d50b5db.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 11 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	327095bd-a7c9-291d-e063-6394a90afafa	2026-06-09	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Chain Drug Marketing Association	34b5c11f-710f-60e4-e063-6394a90a990d	2026-06-09	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Marketing Association	342affe8-0a4d-6fe6-e063-6394a90a8dad	2026-06-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	edc2da26-ae46-4175-86ed-83e1a65f6d14	2026-06-09	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Chain Drug Marketing Association	aa97d2ca-bcf4-3ee1-e053-2a95a90a748d	2026-06-09	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Marketing Association	1bd8e096-1717-4656-b52c-086d2f56f070	2026-06-09	Warnings	Exact identifier application number: M005
BODYKOO JOCK ITCH Cream	CLOTRIMAZOLE1% JOCK ITCH CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	53553b31-81bb-d293-e063-6294a90aa0a5	2026-06-09	Warnings	Exact identifier application number: M005
BODYKOO ATHLETE FOOT Cream	MICONAZOLE NITRATE2% ATHLETE FOOT CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	53561903-54fe-f8ec-e063-6294a90a19fe	2026-06-09	Warnings	Exact identifier application number: M005
Clotrimazole Cream	CLOTRIMAZOLE USP1%	Aldermed Inc.	53bdd76b-6290-f1d3-e063-6394a90a9ff1	2026-06-08	Warnings	Exact identifier application number: M005
Miconazole Cream	MICONAZOLE NITRATE	Aldermed Inc.	4a7fc48a-c103-dc84-e063-6394a90ab80f	2026-06-08	Warnings	Exact identifier application number: M005
Antifungal Powder	MICONAZOLE NITRATE	Aldermed Inc.	60954089-5220-4f4c-8595-b5ee4562562c	2026-06-08	Warnings	Exact identifier application number: M005
Jock Itch Powder	MICONAZOLE NITRATE	Walgreens Company	06d2f36c-8615-af08-e063-6394a90aa424	2026-06-05	Warnings	Exact identifier application number: M005
Miconazole Nitrate 2%	JOCK ITCH SPRAY	Walgreens Company	cf6cbaf4-beba-6fdf-e053-2995a90a76d2	2026-06-04	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5368b131-7537-8679-e063-6394a90a6754	2026-06-04	Warnings	Exact identifier application number: M005
Nail Fungus Treatment Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3fe842e1-b3db-c003-e063-6394a90a46b8	2026-06-04	Warnings	Exact identifier application number: M005
Lasolex AC	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	52bb4bc1-e88f-f5ea-e063-6394a90ae1e8	2026-06-03	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	13a14d3c-bfce-42b5-8463-4ec69e94774e	2026-06-03	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	43cbad59-9899-ab3b-e063-6294a90a9e12	2026-06-02	Warnings	Exact identifier application number: M005
Athletes Foot Cream	CLOTRIMAZOLE	Shenzhen Miandou Technology Co.,Ltd.	53451e74-719e-9499-e063-6394a90a9e5a	2026-06-02	Warnings	Exact identifier application number: M005
Lasolex AL	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	534df9be-b47a-03a1-e063-6394a90a265a	2026-06-02	Warnings	Exact identifier application number: M005

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
1305100	ethanol 75 % Topical Gel	PSN	eae1fc97-eb39-4353-adfa-7c549d50b5db	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	eae1fc97-eb39-4353-adfa-7c549d50b5db	2
1305100	ethanol 75 % Topical Gel	SY	eae1fc97-eb39-4353-adfa-7c549d50b5db	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49314-0004-1	49314000401	25 PACKET in 1 BOX (49314-0004-1) / .9 mL in 1 PACKET	25 packet	2023-11-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
49314-0004 Unishield sanitizer	Unishield \| Nantong Health & Beyond Hygienic Products Inc.	2025-09-24	HUMAN OTC DRUG LABEL	2