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 34 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Topco Associates LLC	be4f41bd-8a75-4fb6-8d28-67f6f853e6bd	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
70% Isopropyl Rubbing Alcohol	ISOPROPYL RUBBING ALCOHOL	Topco Associates LLC	9fbded5f-8dc1-4134-a711-48d1a581d874	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Topco Associates LLC	ad1ef2ea-bfc3-4a8a-acd2-55e7f52813d4	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M003
Antibacterial Wet wipes	BENZALKONIUM CHLORIDE	Zhejiang Easyclean Daily Chemical Co., Ltd.	a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf	2026-02-11	Warnings	Exact identifier application number: M003
Universal ISOPROPYL Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0c76f14b-9a0c-4573-96f2-cd4080eb99e6	2026-02-10	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Walgreen Co.	a08ef11f-5c4f-4821-a0c0-d6c89def0bea	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Walgreen Co.	fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	49e31509-d489-44be-e063-6394a90a97ef	2026-02-10	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	MY IMPORTS USA LLC	4a849c4f-9b96-6b20-e063-6394a90a3486	2026-02-10	Warnings	Exact identifier application number: M003
Medline	ISOPROPYL ALCOHOL	Hy-Vee, Inc.	4bbce274-1e62-0c6a-e063-6394a90af92f	2026-02-10	Warnings	Exact identifier application number: M003
Everlit Care Products Antiseptic Wipe	ANTISEPTIC WIPE	EVERLIT GLOBAL INC.	3331e2f1-c3d0-41fc-a792-be5dcdf4e24a	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS PREP PAD	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	77a60360-8bb5-43e9-b7e4-f71d2d488c44	2026-02-09	Warnings	Exact identifier application number: M003
Everlit Care Products Sting Relief	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	adfab206-b7de-4f6a-a864-edd946ea743d	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS IODINE PREP PAD	POVIDONE-IODINE	EVERLIT GLOBAL INC.	5cbdb73d-333a-4244-a1c0-be430632f0ed	2026-02-09	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	6b8834be-0235-4f7c-8d52-c2f6aa2d3049	2026-02-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Salado Sales Inc.	78a46975-568a-4a88-8597-9603b8bbf935	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M003
70% Rubbing	ISOPROPYL ALCOHOL	Walgreens Co.	6ad37d18-5c19-4b5f-8313-edd430f84fb0	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreens Co.	1473e6e4-dc5f-43d9-a249-111a181e3f76	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 40	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	3584680e-71b0-23b6-e063-6294a90a6998	2026-02-05	Warnings	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 20	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	35865d33-a99f-1b37-e063-6394a90a00d2	2026-02-05	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