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 89 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	ALCOHOL	CMC Group Inc.	dcca50e6-0935-401d-a23e-be4d1231dde9	2025-01-13	Warnings	Exact identifier application number: M003
Refill 2	BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	CMC Group, Inc.	45dde3f0-546c-4ec5-beb0-c3d0432f4983	2025-01-13	Warnings	Exact identifier application number: M003
Refill 3	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CMC Group Inc.	e5cb395f-5037-4b0e-9c9d-2d78b5b01b25	2025-01-13	Warnings	Exact identifier application number: M003
Refill 4	ISOPROPYL ALCOHOL	CMC Group Inc.	6f4a4538-7522-4bcf-b3cf-8dea60438a4d	2025-01-13	Warnings	Exact identifier application number: M003
Refill 6	ALCOHOL, WATER	CMC Group, Inc.	7849ae59-5484-4b86-a0b9-ec9b93d9afe0	2025-01-13	Warnings	Exact identifier application number: M003
EVR Povidone lodine Wipe	POVIDONE LODINE	Changzhou Maokang Medical Products Co., Ltd.	2b57e301-74e0-e1db-e063-6294a90a6c18	2025-01-10	Warnings	Exact identifier application number: M003
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier application number: M003
Medzah Ditek Alcohol Prep Pads	ISOPROPYL ALCOHOL	Medzah Industries	4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac	2025-01-10	Warnings	Exact identifier application number: M003
Alcohol Prep Pad-Large	ISOPROPYL ALCOHOL	Global Biomedical Technologies, LLC	93d00515-e93f-48a3-b66b-7d933e734e54	2025-01-10	Warnings	Exact identifier application number: M003
DERMADIVE ULTRACARE - TETRAID	BENZALKONIUM CHLORIDE	Releaf Technologies LLC	025c0b33-73ca-334b-e063-6394a90ad668	2025-01-09	Warnings	Exact identifier application number: M003
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier application number: M003
BACTINE MAX	BACTINE MAX WOUND WASH	WellSpring Pharmaceutical Corporation	39b26c28-93e0-41a9-8018-f73525ebc015	2025-01-08	Warnings	Exact identifier application number: M003
sterile	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0658a0c8-f5ec-b380-e063-6394a90afff5	2025-01-08	Warnings	Exact identifier application number: M003
Betadine Surgical Scrub	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	1ad39e11-ea1e-44a4-8224-93f8135436c2	2025-01-06	Warnings	Exact identifier application number: M003
First Aid Antiseptic	BENZALKONIUM CHLORIDE	Water-Jel Technologies	2b3cb958-c0c4-47fd-8338-7c7821135f2b	2025-01-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ALCOHOL	Water-Jel Technologies	54e62104-8076-41db-afe5-6dc5c3563acc	2025-01-06	Warnings	Exact identifier application number: M003
Betadine Solution	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	41891599-420e-48d2-8e31-d28a2209e383	2025-01-06	Warnings	Exact identifier application number: M003
Signature Care Alcohol Prep Pad	ISOPROPYL ALCOHOL	Better Living Brands LLC	adc87331-1aa1-3457-e053-2a95a90a7eb1	2025-01-03	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