TOPCARE

Product NDC: 36800-078
11-digit product format: 368000078
Labeler code: 36800
Product ID: 36800-078_cef6ec06-fee6-4708-9f48-46ea005ee776
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: TOPCO ASSOCIATES LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-12-26
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 700 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-078		I	Inactivated by FDA	2026-10-05
excluded product	product	36800-078		I	Inactivated by FDA	2026-10-05
excluded package	package	36800-078	36800-078-02	I	Inactivated by FDA	2026-10-05
excluded package	package	36800-078	36800-078-08	I	Inactivated by FDA	2026-10-05

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 · 84 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 package	package	36800-078-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-078-02	`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 package	package	36800-078-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-078-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-078-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-078-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-078-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-078-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-078-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-078-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-078-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-078-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-078-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-078-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-078-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-078-02	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-078-02	2020-01-31	C162847	48780-1	9d75b9d0-4987-f424-e053-dadaa90a57ce	DRUG FACTS
36800-078-08	2020-01-31	C162847	48780-1	9d75b9d0-a234-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-078-02	TOPCAREVITAMIN E	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59		1
36800-078-08	TOPCAREVITAMIN E	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-078	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20140102_95ab6fcb-c3f5-42e9-a769-1c445da865e2.zip
36800-078	TOPCARE VITAMIN E (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20140102_dd4c2917-96b4-4025-8a34-3ed5ccb3a7c6.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
582753	ethanol 70 % Topical Solution	PSN	95ab6fcb-c3f5-42e9-a769-1c445da865e2	1
582753	ethanol 70 % Topical Solution	PSN	dd4c2917-96b4-4025-8a34-3ed5ccb3a7c6	1
582753	ethanol 0.7 ML/ML Topical Solution	SCD	95ab6fcb-c3f5-42e9-a769-1c445da865e2	1
582753	ethanol 0.7 ML/ML Topical Solution	SCD	dd4c2917-96b4-4025-8a34-3ed5ccb3a7c6	1
582753	ethanol 70 % Topical Solution	SY	95ab6fcb-c3f5-42e9-a769-1c445da865e2	1
582753	ethanol 70 % Topical Solution	SY	dd4c2917-96b4-4025-8a34-3ed5ccb3a7c6	1
582753	ethyl alcohol 70 % Topical Solution	SY	95ab6fcb-c3f5-42e9-a769-1c445da865e2	1
582753	ethyl alcohol 70 % Topical Solution	SY	dd4c2917-96b4-4025-8a34-3ed5ccb3a7c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-078-02	36800007802	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
36800-078-08	36800007808	237 mL in 1 BOTTLE, PLASTIC	237 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2013-12-27	HUMAN OTC DRUG LABEL	1
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2013-12-27	HUMAN OTC DRUG LABEL	1