Alcohol

Product NDC: 49953-2801
11-digit product format: 499532801
Labeler code: 49953
Product ID: 49953-2801_d8272c41-537b-0b77-e053-2a95a90a2def
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl Alcohol
Dosage form: SWAB
Route: TOPICAL
Labeler: Dalian Rongbang Medical Healthy Devices Co., Ltd.
Application: part344
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-07-02
Marketing end: 0000-00-00
Substance: ISOPROPYL ALCOHOL
Active strength: 7 mL/10mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49953-2801		I	Inactivated by FDA	2026-10-15
excluded product	product	49953-2801		I	Inactivated by FDA	2026-10-15
excluded package	package	49953-2801	49953-2801-1	I	Inactivated by FDA	2026-10-15
excluded package	package	49953-2801	49953-2801-2	I	Inactivated by FDA	2026-10-15
excluded package	package	49953-2801	49953-2801-3	I	Inactivated by FDA	2026-10-15

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 2 · 83 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49953-2801-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49953-2801-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49953-2801-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49953-2801-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49953-2801-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49953-2801-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49953-2801-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49953-2801-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49953-2801-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49953-2801-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49953-2801-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49953-2801-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49953-2801-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49953-2801-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49953-2801-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49953-2801-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49953-2801-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49953-2801-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49953-2801-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49953-2801-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49953-2801-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49953-2801-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49953-2801-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49953-2801-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49953-2801-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49953-2801-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49953-2801-3	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
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	49953-2801-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49953-2801-3	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	49953-2801-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49953-2801-3	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	49953-2801-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49953-2801-3	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	49953-2801-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49953-2801-3	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	49953-2801-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49953-2801-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
49953-2801-1	2025-01-30	9d75b9d0-b99b-f424-e053-dadaa90a57ce	Alcohol Prep Pad
49953-2801-1	2022-02-16	9d75b9d0-b99b-f424-e053-dadaa90a57ce	Alcohol Prep Pad
49953-2801-1	2021-07-23	9d75b9d0-b99b-f424-e053-dadaa90a57ce	Alcohol Prep Pad
49953-2801-1	2020-06-03	9d75b9d0-b99b-f424-e053-dadaa90a57ce	Alcohol Prep Pad
49953-2801-1	2020-01-31	9d75b9d0-b99b-f424-e053-dadaa90a57ce	Alcohol Prep Pad
49953-2801-2	2020-01-31	9d75b9d0-b9aa-f424-e053-dadaa90a57ce	Alcohol Swabsticks
49953-2801-3	2020-01-31	9d75b9d0-b9aa-f424-e053-dadaa90a57ce	Alcohol Swabsticks

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49953-2801-1	Alcohol	10 mL in 1 BOX	SWAB	10	9
49953-2801-2	Alcohol	1 mL in 1 POUCH	SWAB	1	7
49953-2801-3	Alcohol	3 mL in 1 POUCH	SWAB	3	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Isopropyl Alcohol	ACTIVE INGREDIENT	ND2M416302	ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES]	4
Isopropyl Alcohol	ACTIVE MOIETY	ND2M416302	ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES]	4
water	INACTIVE INGREDIENT	059QF0KO0R	ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES]	4
Isopropyl Alcohol	ACTIVE INGREDIENT	ND2M416302	ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HELATHY DEVICES CO]	3
Isopropyl Alcohol	ACTIVE MOIETY	ND2M416302	ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HELATHY DEVICES CO]	3
water	INACTIVE INGREDIENT	059QF0KO0R	ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HELATHY DEVICES CO]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49953-2801	ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES CO., LTD.]	9	Legacy NDC, 1 package rows	20231229_f87ee492-3db6-4a08-b736-1118c18f671a.zip
49953-2801	ALCOHOL (ISOPROPYL ALCOHOL) SWAB [DALIAN RONGBANG MEDICAL HEALTHY DEVICES CO., LTD.]	7	Legacy NDC, 2 package rows	20161129_04191cac-54e5-41ce-95fb-b8d24e1f40b6.zip

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	f87ee492-3db6-4a08-b736-1118c18f671a	9
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	f87ee492-3db6-4a08-b736-1118c18f671a	9
797544	isopropyl alcohol 70 % Medicated Pad	SY	f87ee492-3db6-4a08-b736-1118c18f671a	9
797544	isopropyl alcohol 70 % Topical Cloth	SY	f87ee492-3db6-4a08-b736-1118c18f671a	9
797544	isopropyl alcohol 70 % Topical Swab	SY	f87ee492-3db6-4a08-b736-1118c18f671a	9
797544	isopropyl alcohol 70 % Medicated Pad	PSN	04191cac-54e5-41ce-95fb-b8d24e1f40b6	7
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	04191cac-54e5-41ce-95fb-b8d24e1f40b6	7
797544	isopropyl alcohol 70 % Medicated Pad	SY	04191cac-54e5-41ce-95fb-b8d24e1f40b6	7
797544	isopropyl alcohol 70 % Topical Cloth	SY	04191cac-54e5-41ce-95fb-b8d24e1f40b6	7
797544	isopropyl alcohol 70 % Topical Swab	SY	04191cac-54e5-41ce-95fb-b8d24e1f40b6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49953-2801-1	49953280101	10 mL in 1 BOX (49953-2801-1)	10 ml	2010-07-02	0000-00-00	No	No	Current
49953-2801-2	49953280102	1 mL in 1 POUCH	1 ml					Historical
49953-2801-3	49953280103	3 mL in 1 POUCH	3 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alcohol Prep Pad	Dalian Rongbang Medical Healthy Devices Co., Ltd.	2023-12-28	HUMAN OTC DRUG LABEL	9
Alcohol Swabsticks	Dalian Rongbang Medical Healthy Devices Co., Ltd.	2016-11-28	HUMAN OTC DRUG LABEL	7