CareOne

Product NDC: 41520-410
11-digit product format: 415200410
Labeler code: 41520
Product ID: 41520-410_b88957ae-1522-4a82-b8ce-c7bfb3f223c5
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: American Sales Company
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-05-16
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 650 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	41520-410		I	Inactivated by FDA	2026-10-15
excluded product	product	41520-410		I	Inactivated by FDA	2026-10-15
excluded product	product	41520-410		I	Inactivated by FDA	2026-10-15
excluded package	package	41520-410	41520-410-09	I	Inactivated by FDA	2026-10-15
excluded package	package	41520-410	41520-410-02	I	Inactivated by FDA	2026-10-15
excluded package	package	41520-410	41520-410-03	I	Inactivated by FDA	2026-10-15
excluded package	package	41520-410	41520-410-08	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 3 · 147 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-410-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-410-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-410-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-410-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-410-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-410-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-410-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-410-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-410-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-410-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-410-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-410-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-410-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-410-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-410-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-410-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-410-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-410-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-410-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-410-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-410-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-410-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-410-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-410-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-410-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-410-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-410-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-410-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-410-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-410-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-410-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-410-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41520-410-02	`0efc9e666f02…`	`f202fb6c5f17…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
41520-410-02	9d75b9cf-f1b2-f424-e053-dadaa90a57ce	DRUG FACTS
41520-410-03	9d75b9d0-82e1-f424-e053-dadaa90a57ce	68ba65c6-4ba7-44fe-a443-6ec4bec77414
41520-410-08	9d75b9d0-82e1-f424-e053-dadaa90a57ce	68ba65c6-4ba7-44fe-a443-6ec4bec77414
41520-410-09	9d75b9cf-f248-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41520-410-02	CAREONECOUNTRY APPLE	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59	1
41520-410-03	CareOneCountry Apple	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59	1
41520-410-08	CareOneCountry Apple	259 mL in 1 BOTTLE, PLASTIC	LIQUID	259	1
41520-410-09	CAREONECOUNTRY APPLE	259 mL in 1 BOTTLE, PLASTIC	LIQUID	259	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
SULIBENZONE	INACTIVE INGREDIENT	853Z42ZYAS	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
SULISOBENZONE	INACTIVE INGREDIENT	1W6L629B4K	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-410	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1	Legacy NDC, 1 package rows	20140207_1ababffd-155a-4c02-bc9c-f991594bfd34.zip
41520-410	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1	Legacy NDC, 2 package rows	20170518_68ba65c6-4ba7-44fe-a443-6ec4bec77414.zip
41520-410	CAREONE COUNTRY APPLE (ETHYL ALCOHOL) LIQUID [AMERICAN SALES COMPANY]	1	Legacy NDC, 1 package rows	20140221_7be69434-11dc-484b-b565-8b1ab1269c2a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884783	ethanol 65 % Topical Solution	PSN	1ababffd-155a-4c02-bc9c-f991594bfd34	1
884783	ethanol 65 % Topical Solution	PSN	68ba65c6-4ba7-44fe-a443-6ec4bec77414	1
884783	ethanol 65 % Topical Solution	PSN	7be69434-11dc-484b-b565-8b1ab1269c2a	1
884783	ethanol 0.65 ML/ML Topical Solution	SCD	1ababffd-155a-4c02-bc9c-f991594bfd34	1
884783	ethanol 0.65 ML/ML Topical Solution	SCD	68ba65c6-4ba7-44fe-a443-6ec4bec77414	1
884783	ethanol 0.65 ML/ML Topical Solution	SCD	7be69434-11dc-484b-b565-8b1ab1269c2a	1
884783	ethanol 65 % Topical Solution	SY	1ababffd-155a-4c02-bc9c-f991594bfd34	1
884783	ethanol 65 % Topical Solution	SY	68ba65c6-4ba7-44fe-a443-6ec4bec77414	1
884783	ethanol 65 % Topical Solution	SY	7be69434-11dc-484b-b565-8b1ab1269c2a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
41520-410-02	41520041002	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
41520-410-03	41520041003	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
41520-410-08	41520041008	259 mL in 1 BOTTLE, PLASTIC	259 ml	Historical
41520-410-09	41520041009	259 mL in 1 BOTTLE, PLASTIC	259 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ethyl Alcohol - American Sales Company \| Apollo Health and Beauty Care Inc.	American Sales Company \| Apollo Health and Beauty Care Inc.	2017-05-17	HUMAN OTC DRUG LABEL	1
DRUG FACTS	AMERICAN SALES COMPANY \| APOLLO HEALTH AND BEAUTY CARE	2014-02-21	HUMAN OTC DRUG LABEL	1
DRUG FACTS	AMERICAN SALES COMPANY \| APOLLO HEALTH AND BEAUTY CARE	2014-02-07	HUMAN OTC DRUG LABEL	1