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 64 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer Velvet Vanilla	ALCOHOL	Scent Theory Products LLC	3f8fdb54-2e2c-2cab-e063-6394a90a1f09	2025-09-24	Warnings	Exact identifier application number: M003
Hand Sanitizer Sun-Kissed Melon	ALCOHOL	Scent Theory Products LLC	3f8fe3c4-1373-b45a-e063-6294a90ae05b	2025-09-24	Warnings	Exact identifier application number: M003
First Aid Direct Hand Sanitizer	HAND SANITIZER	Cintas Corporation	dad0fc5d-4a48-4db1-b423-558c2958750c	2025-09-24	Warnings	Exact identifier application number: M003
Xpect Hydrogen Peroxide	HYDROGEN PEROXIDE	Cintas Corporation	793afae4-5270-4be7-b41a-269b4e59bcad	2025-09-23	Warnings	Exact identifier application number: M003
HUMCO 1 Percent Iodine	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	139efeef-be20-4362-a5ba-158b8fa40e0d	2025-09-22	Warnings	Exact identifier application number: M003
Xpect Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cintas Corp	b55fe473-45d2-48d3-b4d4-fc0993cb4dfe	2025-09-22	Warnings	Exact identifier application number: M003
Xpect Antiseptic	BENZALKONIUM CHLORIDE	Cintas Corporation	d9a31a11-e80f-4ded-ad0a-34f93b01557e	2025-09-22	Warnings	Exact identifier application number: M003
3 Hydrogen Peroxide	HYDROGEN PEROXIDE	Midwood Brands LLC	3f2cea6a-269a-a19b-e063-6294a90a29a9	2025-09-19	Warnings	Exact identifier application number: M003
MOONIES Minee Wipes Antibacterial Hand Wipe	BENZALKONIUM CHLORIDE	Hangzhou Chunchi Touring Commodity Co., Ltd.	3eee1a5c-e926-5251-e063-6294a90a5d2e	2025-09-17	Warnings	Exact identifier application number: M003
MISTIFY SANITIZER WATERMELON	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3efef0a5-ff5e-f2b0-e063-6294a90a1efa	2025-09-17	Warnings	Exact identifier application number: M003
MISTIFY SANITIZER VANILLA	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff0ac8-1cf5-3681-e063-6294a90a8705	2025-09-17	Warnings	Exact identifier application number: M003
KISSES SANITIZER WHITE CHOCOLATE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff2e43-9254-e7ff-e063-6394a90a0aea	2025-09-17	Warnings	Exact identifier application number: M003
REESES SANITIZER CHOCOLATE PEANUT BUTTER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff4496-ce10-f1c1-e063-6394a90aaff2	2025-09-17	Warnings	Exact identifier application number: M003
SWEDISH FISH SANITIZER MIX BERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff6cc3-50d8-1308-e063-6394a90a6ac2	2025-09-17	Warnings	Exact identifier application number: M003
TWIZZLERS SANITIZER STRAWBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff5918-e247-c171-e063-6294a90aa0f8	2025-09-17	Warnings	Exact identifier application number: M003
FLUFFY STUFF SANITIZER COTTON CANDY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3eff7fd6-5e3d-f38b-e063-6294a90afc02	2025-09-17	Warnings	Exact identifier application number: M003
MISTIFY SANITIZER CARAMEL PISTACHIO	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3effa71e-bbf1-36de-e063-6294a90ab9e3	2025-09-17	Warnings	Exact identifier application number: M003
STRAWBERRY SHORTCAKE SANITIZER STRAWBERRY ICING	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3f033c93-1438-8b8d-e063-6394a90a93b5	2025-09-17	Warnings	Exact identifier application number: M003
Sherk sanitizer waffle syrup	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3f0357e9-35c2-f983-e063-6294a90a5dac	2025-09-17	Warnings	Exact identifier application number: M003
STRAWBERRY SHORTCAKE SANITIZER STRAWBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	3f032275-4c3f-6d78-e063-6394a90a038d	2025-09-17	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