TOPCARE

Product NDC: 36800-464
11-digit product format: 368000464
Labeler code: 36800
Product ID: 36800-464_f0184a86-e618-4b5b-9d74-77b6bb86165c
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: 2013-03-19
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 620 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	36800-464		I	Inactivated by FDA	2026-10-12
excluded product	product	36800-464		I	Inactivated by FDA	2026-10-12
excluded package	package	36800-464	36800-464-09	I	Inactivated by FDA	2026-10-12
excluded package	package	36800-464	36800-464-02	I	Inactivated by FDA	2026-10-12

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	36800-464-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-464-09	`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	36800-464-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-464-09	`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	36800-464-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-464-09	`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	36800-464-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-464-09	`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	36800-464-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-464-09	`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	36800-464-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-464-09	`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	36800-464-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-464-09	`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	36800-464-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-464-09	`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	36800-464-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-464-09	`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	36800-464-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-464-09	`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	36800-464-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-464-09	`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	36800-464-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-464-09	`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	36800-464-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-464-09	`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	36800-464-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-464-09	`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	36800-464-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-464-09	`1332a3947898…`	`d4bfe170f9cd…`

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-464-02	2020-01-31	C162847	48780-1	9d75b9d0-042a-f424-e053-dadaa90a57ce	DRUG FACTS
36800-464-09	2020-01-31	C162847	48780-1	9d75b9d0-df7b-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-464-02	TOPCARECOCONUT CREAM	59 mL in 1 BOTTLE, PLASTIC	LIQUID	59		1
36800-464-09	TOPCARECOCONUT CREAM	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	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE COCONUT CREAM (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
36800-464	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20130322_0f62b4de-2c07-436f-a369-acef03ca7267.zip
36800-464	TOPCARE COCONUT CREAM (ETHYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20130322_b88220f1-2c83-41d0-abc7-e74ccd299087.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
247835	ethanol 62 % Topical Solution	PSN	0f62b4de-2c07-436f-a369-acef03ca7267	1
247835	ethanol 62 % Topical Solution	PSN	b88220f1-2c83-41d0-abc7-e74ccd299087	1
247835	ethanol 0.62 ML/ML Topical Solution	SCD	0f62b4de-2c07-436f-a369-acef03ca7267	1
247835	ethanol 0.62 ML/ML Topical Solution	SCD	b88220f1-2c83-41d0-abc7-e74ccd299087	1
247835	ethanol 62 % Topical Solution	SY	0f62b4de-2c07-436f-a369-acef03ca7267	1
247835	ethanol 62 % Topical Solution	SY	b88220f1-2c83-41d0-abc7-e74ccd299087	1
247835	ethyl alcohol 62 % Topical Solution	SY	0f62b4de-2c07-436f-a369-acef03ca7267	1
247835	ethyl alcohol 62 % Topical Solution	SY	b88220f1-2c83-41d0-abc7-e74ccd299087	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-464-02	36800046402	59 mL in 1 BOTTLE, PLASTIC	59 ml	Historical
36800-464-09	36800046409	259 mL in 1 BOTTLE, PLASTIC	259 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2013-03-21	HUMAN OTC DRUG LABEL	1
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2013-03-21	HUMAN OTC DRUG LABEL	1