SP NEWGEL

Product NDC: 78125-001
11-digit product format: 781250001
Labeler code: 78125
Product ID: 78125-001_a79548c3-a019-d774-e053-2a95a90a422d
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: SOUTHERN PHARMA COMPANY LIMITED
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-01-01
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78125-001		I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78125-001	78125-001-07	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 3 · 144 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	78125-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78125-001-07	`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	78125-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78125-001-07	`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	78125-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78125-001-07	`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	78125-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78125-001-07	`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	78125-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78125-001-07	`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	78125-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78125-001-07	`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 package	package	78125-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78125-001-07	`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 package	package	78125-001-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78125-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78125-001-05	`ed331223b511…`	`672a5bd82f5f…`

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
78125-001-01	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-02	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-03	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-04	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-05	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-06	a5fcb894-25d5-4150-e053-2995a90adb0b
78125-001-07	a5fcb894-25d5-4150-e053-2995a90adb0b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78125-001-01	SP NEWGEL	50 mL in 1 BOTTLE, PLASTIC	GEL	50	2
78125-001-02	SP NEWGEL	100 mL in 1 BOTTLE	GEL	100	2
78125-001-03	SP NEWGEL	250 mL in 1 BOTTLE, PUMP	GEL	250	2
78125-001-04	SP NEWGEL	500 mL in 1 BOTTLE, PUMP	GEL	500	2
78125-001-05	SP NEWGEL	980 mL in 1 BOTTLE, PUMP	GEL	980	2
78125-001-06	SP NEWGEL	3780 mL in 1 CAN	GEL	3780	2
78125-001-07	SP NEWGEL	5000 mL in 1 CAN	GEL	5000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78125-001	SP NEWGEL (ALCOHOL) GEL [SOUTHERN PHARMA COMPANY LIMITED]	2	Legacy NDC, 7 package rows	20200609_a5fcb894-25d5-4150-e053-2995a90adb0b.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
1041498	ethanol 80 % Topical Gel	PSN	a5fcb894-25d5-4150-e053-2995a90adb0b	2
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a5fcb894-25d5-4150-e053-2995a90adb0b	2
1041498	ethanol 80 % Topical Gel	SY	a5fcb894-25d5-4150-e053-2995a90adb0b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78125-001-01	78125000101	50 mL in 1 BOTTLE, PLASTIC (78125-001-01)	50 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-02	78125000102	100 mL in 1 BOTTLE (78125-001-02)	100 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-03	78125000103	250 mL in 1 BOTTLE, PUMP (78125-001-03)	250 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-04	78125000104	500 mL in 1 BOTTLE, PUMP (78125-001-04)	500 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-05	78125000105	980 mL in 1 BOTTLE, PUMP (78125-001-05)	980 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-06	78125000106	3780 mL in 1 CAN (78125-001-06)	3780 ml	2020-02-15	0000-00-00	No	No	Current
78125-001-07	78125000107	5000 mL in 1 CAN (78125-001-07)	5000 ml	2020-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SP NEWGEL - SOUTHERN PHARMA COMPANY LIMITED	SOUTHERN PHARMA COMPANY LIMITED	2020-06-08	HUMAN OTC DRUG LABEL	2