HAPPY HANDS

Product NDC: 80849-001
11-digit product format: 808490001
Labeler code: 80849
Product ID: 80849-001_ce68c3ba-ebc0-49e6-a4c4-677defb9c6dd
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: American Ethanol Company, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-10-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80849-001		I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-01	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-02	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-03	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-04	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-05	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-06	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-07	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-08	I	Inactivated by FDA	2026-10-15
excluded package	package	80849-001	80849-001-09	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 · 180 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 package	package	80849-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80849-001-07	`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 package	package	80849-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80849-001-07	`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 package	package	80849-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80849-001-07	`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 package	package	80849-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80849-001-07	`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 package	package	80849-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80849-001-07	`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 package	package	80849-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80849-001-07	`cdf11ea48f46…`	`ba0047e9e063…`

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
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
80849-001-01	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-02	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-03	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-04	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-05	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-06	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-07	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-08	1522cce7-e684-48c2-97ef-48562752c2a0
80849-001-09	1522cce7-e684-48c2-97ef-48562752c2a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80849-001-01	HAPPY HANDS	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	1
80849-001-02	HAPPY HANDS	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236	1
80849-001-03	HAPPY HANDS	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473	1
80849-001-04	HAPPY HANDS	500 mL in 1 BOTTLE, PLASTIC	LIQUID	500	1
80849-001-05	HAPPY HANDS	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946	1
80849-001-06	HAPPY HANDS	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000	1
80849-001-07	HAPPY HANDS	3000 mL in 1 BOTTLE, PLASTIC	LIQUID	3000	1
80849-001-08	HAPPY HANDS	3785 mL in 1 BOTTLE, PLASTIC	LIQUID	3785	1
80849-001-09	HAPPY HANDS	1040990 mL in 1 DRUM	LIQUID	1040990	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80849-001	HAPPY HANDS (ALCOHOL) LIQUID [AMERICAN ETHANOL COMPANY, LLC]	1	Legacy NDC, 9 package rows	20201028_1522cce7-e684-48c2-97ef-48562752c2a0.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
1039339	ethanol 80 % Topical Solution	PSN	1522cce7-e684-48c2-97ef-48562752c2a0	1
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	1522cce7-e684-48c2-97ef-48562752c2a0	1
1039339	ethanol 80 % Topical Solution	SY	1522cce7-e684-48c2-97ef-48562752c2a0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80849-001-01	80849000101	118 mL in 1 BOTTLE, PLASTIC (80849-001-01)	118 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-02	80849000102	236 mL in 1 BOTTLE, PLASTIC (80849-001-02)	236 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-03	80849000103	473 mL in 1 BOTTLE, PLASTIC (80849-001-03)	473 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-04	80849000104	500 mL in 1 BOTTLE, PLASTIC (80849-001-04)	500 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-05	80849000105	946 mL in 1 BOTTLE, PLASTIC (80849-001-05)	946 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-06	80849000106	1000 mL in 1 BOTTLE, PLASTIC (80849-001-06)	1000 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-07	80849000107	3000 mL in 1 BOTTLE, PLASTIC (80849-001-07)	3000 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-08	80849000108	3785 mL in 1 BOTTLE, PLASTIC (80849-001-08)	3785 ml	2020-10-01	0000-00-00	No	No	Current
80849-001-09	80849000109	1040990 mL in 1 DRUM (80849-001-09)	1040990 ml	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HAPPY HANDS - American Ethanol Company, LLC	American Ethanol Company, LLC	2020-10-26	HUMAN OTC DRUG LABEL	1