Sterile Alcohol

Product NDC: 63868-980
11-digit product format: 638680980
Labeler code: 63868
Product ID: 63868-980_2ad55938-0101-3a3f-e063-6394a90af7f5
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl alcohol
Dosage form: SWAB
Route: TOPICAL
Labeler: Chain Drug Marketing Association Inc
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-30
Marketing end: 2026-11-30
Substance: ISOPROPYL ALCOHOL
Active strength: .7 mL/1
NDC exclude flag: No
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 · 18 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
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-980-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-980-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-980-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63868-980-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63868-980-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63868-980-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63868-980-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63868-980-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63868-980-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Sterile Alcohol

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROPYL ALCOHOL	.7 mL/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ND2M416302	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797544	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
55922632-3768-4450-9389-ba7d7d91f2c9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-03	63868-980 Chain Drug Marketing Association IPA Pad
2024-01-30	63868-980 Chain Drug Marketing Association IPA Pad
2021-01-25	63868-980 Chain Drug Marketing Association IPA Pad
2020-01-31	63868-980 Chain Drug Marketing Association IPA Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-980-01	Sterile Alcohol	1 in 1 PACKET	SWAB	1		8
63868-980-01	Sterile Alcohol	100 in 1 BOX	SWAB	100		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISOPROPYL ALCOHOL	ACTIVE INGREDIENT	ND2M416302	STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]	3
ISOPROPYL ALCOHOL	ACTIVE MOIETY	ND2M416302	STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-980	STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC]	8	Current NDC, Legacy NDC, 2 package rows	20250105_55922632-3768-4450-9389-ba7d7d91f2c9.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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand sanitizer 16.9oz with vitamin E	ETHYL ALCOHOL 70%	REJOICE INTERNATIONAL CORP.	03f869b3-3004-8b25-e063-6294a90a176e	2025-02-06	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent Wintergreen	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	444cd7f4-cf61-49b6-a93e-915d250838da	2025-02-06	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIA	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d613ab9-c87b-1f3c-e063-6394a90a3120	2025-02-05	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUT	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d6148e2-d959-6150-e063-6294a90acba5	2025-02-05	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELON	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d6175c9-abe5-4c68-e063-6394a90afc36	2025-02-05	Warnings	Exact identifier application number: M003
Hand sanitizer 29ml 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	eb5d6739-ee36-cd74-e053-2a95a90ab659	2025-02-05	Warnings	Exact identifier application number: M003
Hand sanitizer 29ml 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	037b4acb-49ca-bc0a-e063-6394a90a1fcc	2025-02-05	Warnings	Exact identifier application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPES	BENZALKONIUM CHLORIDE	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.	ecef31dc-2f36-b578-e053-2995a90a3acd	2025-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 91 percent	ISOPROPYL ALCOHOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	444883fc-7ae4-4dd3-bd2b-f94c3265c170	2025-02-05	Warnings	Exact identifier application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PAD	ISOPROPYL ALCOHOL	Simple Diagnostics	0fc4a4b2-342b-5948-e054-00144ff88e88	2025-02-04	Warnings	Exact identifier application number: M003
HAND SANITIZER VANILLA	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	32055326-c229-5f10-e063-6394a90ab62c	2025-02-01	Warnings	Exact identifier application number: M003
Hand Sanitizer Pink Sugar	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	322e5a64-dda1-c24e-e063-6394a90a8298	2025-02-01	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Jianerkang Medical Co., Ltd	3fce67c9-14e9-4e26-bb7f-9375a7f84a8a	2025-01-31	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL	Welly Health PCB	85ce2c23-25d8-4b35-95ff-99f098d92bc9	2025-01-29	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International Corp.	4e13511b-fbb3-2523-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Hand Sanitizer 1.8 oz Strawberry Scented	ETHYL ALCOHOL	Ningbo Rejoice International	a267a7a2-79b9-1da3-e053-2995a90a3a11	2025-01-28	Warnings	Exact identifier application number: M003
On Guard Sanitizing Gel	ALCOHOL	doTERRA International, LLC	e4b8b4bb-1d47-6826-e053-2a95a90ab168	2025-01-28	Warnings	Exact identifier application number: M003
germstarLuxe	ETHYL ALCOHOL	Soaptronic, LLC	471b466f-e3e5-3601-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	GFA Production (Xiamen) Co., Ltd.	51348666-53e3-4cc7-99ba-cf3f23ddbcf6	2025-01-27	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	GFA Production (Xiamen) Co., Ltd.	0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa	2025-01-27	Warnings	Exact identifier application number: M003

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
797544	isopropyl alcohol 70 % Medicated Pad	PSN	55922632-3768-4450-9389-ba7d7d91f2c9	8
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	55922632-3768-4450-9389-ba7d7d91f2c9	8
797544	isopropyl alcohol 70 % Medicated Pad	SY	55922632-3768-4450-9389-ba7d7d91f2c9	8
797544	isopropyl alcohol 70 % Topical Cloth	SY	55922632-3768-4450-9389-ba7d7d91f2c9	8
797544	isopropyl alcohol 70 % Topical Swab	SY	55922632-3768-4450-9389-ba7d7d91f2c9	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-980-01	63868098001	100 PACKET in 1 BOX (63868-980-01) / 1 SWAB in 1 PACKET	100 packet	2017-03-10	2026-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
63868-980 Chain Drug Marketing Association IPA Pad	Chain Drug Marketing Association Inc \| Medline Industries, LP	2025-01-03	HUMAN OTC DRUG LABEL	8