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 31 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
70%	ISOPROPYL ALCOHOL	United Natural Foods, Inc. dba UNFI	d39bc652-442d-4d91-9eba-a496636b9533	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	United Natural Foods, Inc. dba UNFI	f6be70d5-763c-42d8-9b4e-a55e84c74785	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: M003
Rubbing	ETHYL ALCOHOL	United Natural Foods, Inc. dba UNFI	cd03611f-879a-4888-8d45-f8bdfd82529c	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: M003
Lightning X POVIDONE IODINE WIPE	POVIDONE IODINE WIPE	Changzhou Maokang Medical Products Co., Ltd.	04be4c2f-742b-7058-e063-6394a90a460d	2026-02-25	Warnings	Exact identifier application number: M003
70% Isopropyl Rubbing Alcohol	ISOPROPYL RUBBING ALCOHOL	Better Living Brands, LLC	4817df03-05a2-4e85-bec2-a06f9d57d0b8	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Better Living Brands, LLC	4031ea5d-cba4-44f5-9a81-0cab2367d97e	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Better Living Brands, LLC	1b2decdf-58be-4ab9-a481-6c78bd91faf0	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Better Living Brands, LLC	6391432a-a5b8-4528-88a6-862bc2062f68	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Family Dollar Stores, Inc	58157bc5-54ea-49f8-9f17-f0eeb5732395	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl	ISOPROPYL ALCOHOL	H E B	25fea857-9ed8-49e7-b892-b24f639f83ca	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	H E B	403e52e8-bac1-460a-81ef-bac5a7b5de10	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	H E B	28cd16f5-61c5-4943-9dd6-a9864fa35806	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
50% Isopropyl Alcohol	ISOPROPYL ALCOHOL	H E B	0ed762dd-9432-45b4-9e75-c24fb28ff956	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M003
Sunvine 70 Isopropyl Alcohol First Aid Antiseptic	ISOPROPYL ALCOHOL	Mac Innovations, LLC	8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c76	2026-02-24	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	ALCOVE BRANDS	4bad1fee-b4fe-c518-e063-6294a90a0318	2026-02-24	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Better Living Brands, LLC	3ce6e6af-b513-ed9f-e063-6394a90a4ce7	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M003
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy Pear	ALCOHOL	Scent Theory Products LLC	4b865d82-71c3-1023-e063-6294a90ac774	2026-02-23	Warnings	Exact identifier application number: M003
Hydrogen Peroxide 3%	HYDROGEN PEROXIDE 3%	4 Visions LLC	4b87254a-8dc5-3873-e063-6394a90a3f3b	2026-02-23	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	4 Visions LLC	4b87d4cc-163e-1432-e063-6294a90af483	2026-02-23	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	4 Visions LLC	4b88008f-fe78-4b7e-e063-6294a90ab9ae	2026-02-23	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