Champ

Product NDC: 78658-001
11-digit product format: 786580001
Labeler code: 78658
Product ID: 78658-001_6ff97ece-90df-4e1f-a488-894ed9d34ee3
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Champ Products, Ltd
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-24
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78658-001		I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-01	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-02	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-03	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-04	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-05	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-06	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-07	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-08	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-09	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-10	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-11	I	Inactivated by FDA	2026-10-12
excluded package	package	78658-001	78658-001-12	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 4 · 234 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	78658-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78658-001-03	`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 package	package	78658-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78658-001-03	`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 package	package	78658-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78658-001-03	`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 package	package	78658-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78658-001-03	`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 package	package	78658-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78658-001-12	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78658-001-01	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-02	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-03	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-04	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-05	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-06	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-07	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-08	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-09	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-10	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-11	f7d9d723-e821-4d1b-a22a-9d7023029f0f
78658-001-12	f7d9d723-e821-4d1b-a22a-9d7023029f0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78658-001-01	Champ	30 mL in 1 BOTTLE, PLASTIC	GEL	30	1
78658-001-02	Champ	59 mL in 1 BOTTLE, PLASTIC	GEL	59	1
78658-001-03	Champ	104 mL in 1 BOTTLE, PLASTIC	GEL	104	1
78658-001-04	Champ	118 mL in 1 BOTTLE, PLASTIC	GEL	118	1
78658-001-05	Champ	177 mL in 1 BOTTLE, PLASTIC	GEL	177	1
78658-001-06	Champ	236 mL in 1 BOTTLE, PLASTIC	GEL	236	1
78658-001-07	Champ	296 mL in 1 BOTTLE, PLASTIC	GEL	296	1
78658-001-08	Champ	473 mL in 1 BOTTLE, PLASTIC	GEL	473	1
78658-001-09	Champ	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	1
78658-001-10	Champ	3785 mL in 1 BOTTLE, PLASTIC	GEL	3785	1
78658-001-11	Champ	208198 mL in 1 BOTTLE, PLASTIC	GEL	208198	1
78658-001-12	Champ	1040990 mL in 1 BOTTLE, PLASTIC	GEL	1040990	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78658-001	CHAMP (ALCOHOL) GEL [CHAMP PRODUCTS, LTD]	1	Legacy NDC, 12 package rows	20200604_f7d9d723-e821-4d1b-a22a-9d7023029f0f.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
581662	ethanol 70 % Topical Gel	PSN	f7d9d723-e821-4d1b-a22a-9d7023029f0f	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	f7d9d723-e821-4d1b-a22a-9d7023029f0f	1
581662	ethanol 70 % Topical Gel	SY	f7d9d723-e821-4d1b-a22a-9d7023029f0f	1
581662	ethyl alcohol 70 % Topical Gel	SY	f7d9d723-e821-4d1b-a22a-9d7023029f0f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78658-001-01	78658000101	30 mL in 1 BOTTLE, PLASTIC (78658-001-01)	30 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-02	78658000102	59 mL in 1 BOTTLE, PLASTIC (78658-001-02)	59 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-03	78658000103	104 mL in 1 BOTTLE, PLASTIC (78658-001-03)	104 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-04	78658000104	118 mL in 1 BOTTLE, PLASTIC (78658-001-04)	118 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-05	78658000105	177 mL in 1 BOTTLE, PLASTIC (78658-001-05)	177 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-06	78658000106	236 mL in 1 BOTTLE, PLASTIC (78658-001-06)	236 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-07	78658000107	296 mL in 1 BOTTLE, PLASTIC (78658-001-07)	296 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-08	78658000108	473 mL in 1 BOTTLE, PLASTIC (78658-001-08)	473 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-09	78658000109	1000 mL in 1 BOTTLE, PLASTIC (78658-001-09)	1000 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-10	78658000110	3785 mL in 1 BOTTLE, PLASTIC (78658-001-10)	3785 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-11	78658000111	208198 mL in 1 BOTTLE, PLASTIC (78658-001-11)	208198 ml	2020-05-24	0000-00-00	No	No	Current
78658-001-12	78658000112	1040990 mL in 1 BOTTLE, PLASTIC (78658-001-12)	1040990 ml	2020-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Champ - Champ Products, Ltd \| Aegle Nutrition LLC	Champ Products, Ltd \| Aegle Nutrition LLC	2020-05-08	HUMAN OTC DRUG LABEL	1