Tera-Gel

Product NDC: 54162-250
11-digit product format: 541620250
Labeler code: 54162
Product ID: 54162-250_a690acc1-0906-411d-bb5b-16ce09797278
Type: HUMAN OTC DRUG
Nonproprietary name: COAL TAR
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Geritrex LLC
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: COAL TAR
Active strength: 1 g/237mL
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	54162-250		I	Inactivated by FDA	2026-10-05
excluded product	product	54162-250		I	Inactivated by FDA	2026-10-05
excluded package	package	54162-250	54162-250-04	I	Inactivated by FDA	2026-10-05
excluded package	package	54162-250	54162-250-80	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	54162-250-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-250-04	`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	54162-250-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-250-04	`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	54162-250-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-250-04	`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	54162-250-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-250-04	`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	54162-250-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-250-04	`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	54162-250-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-250-04	`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	54162-250-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-250-04	`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	54162-250-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-250-04	`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	54162-250-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-250-04	`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	54162-250-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-250-04	`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	54162-250-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-250-04	`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	54162-250-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-250-04	`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	54162-250-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-250-04	`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	54162-250-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-250-04	`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	54162-250-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-250-04	`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
54162-250-04	2020-01-31	C162847	48780-1	9d75b9d0-27c1-f424-e053-dadaa90a57ce	Tera-Gel Shampoo
54162-250-80	2020-01-31	C162847	48780-1	9d75b9cf-fcd1-f424-e053-dadaa90a57ce	Tera-Gel Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-250-04	Tera-Gel	114 mL in 1 BOTTLE, PLASTIC	SHAMPOO	114		1
54162-250-80	Tera-Gel	237 mL in 1 BOTTLE, PLASTIC	SHAMPOO	237		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-250-04	ML - Milliliter	54162-250	97ab7a99-304b-4158-b9ac-674e4dc35cd2	1	2016-02-04
54162-250-80	ML - Milliliter	54162-250	f7d093e1-aeb6-497d-af65-c3a7b7b82398	1	2016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-250	TERA-GEL (COAL TAR) SHAMPOO [GERITREX LLC]	1	Legacy NDC, 1 package rows	20160129_6f079fa9-2fa2-4988-ae1b-46b8fd670fac.zip
54162-250	TERA-GEL (COAL TAR) SHAMPOO [GERITREX LLC]	1	Legacy NDC, 1 package rows	20160129_445603e2-4839-4391-a665-a44a318036cd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R533ESO2EC	COAL TAR	8007-45-2	COAL TAR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309381	coal tar 0.5 % Medicated Shampoo	PSN	445603e2-4839-4391-a665-a44a318036cd	1
309381	coal tar 0.5 % Medicated Shampoo	PSN	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
284305	Tera Gel 0.5 % Medicated Shampoo	PSN	445603e2-4839-4391-a665-a44a318036cd	1
284305	Tera Gel 0.5 % Medicated Shampoo	PSN	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
284305	coal tar 5 MG/ML Medicated Shampoo [Tera Gel]	SBD	445603e2-4839-4391-a665-a44a318036cd	1
284305	coal tar 5 MG/ML Medicated Shampoo [Tera Gel]	SBD	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
309381	coal tar 5 MG/ML Medicated Shampoo	SCD	445603e2-4839-4391-a665-a44a318036cd	1
309381	coal tar 5 MG/ML Medicated Shampoo	SCD	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
309381	coal tar 0.5 % Medicated Shampoo	SY	445603e2-4839-4391-a665-a44a318036cd	1
309381	coal tar 0.5 % Medicated Shampoo	SY	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
309381	crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated Shampoo	SY	445603e2-4839-4391-a665-a44a318036cd	1
309381	crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated Shampoo	SY	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
284305	Tera Gel 0.5 % Medicated Shampoo	SY	445603e2-4839-4391-a665-a44a318036cd	1
284305	Tera Gel 0.5 % Medicated Shampoo	SY	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1
284305	Tera Gel 5 MG/ML Medicated Shampoo	SY	445603e2-4839-4391-a665-a44a318036cd	1
284305	Tera Gel 5 MG/ML Medicated Shampoo	SY	6f079fa9-2fa2-4988-ae1b-46b8fd670fac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-250-04	54162025004	114 mL in 1 BOTTLE, PLASTIC	114 ml	Historical
54162-250-80	54162025080	237 mL in 1 BOTTLE, PLASTIC	237 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tera-Gel Shampoo	Geritrex LLC	2016-01-19	HUMAN OTC DRUG LABEL	1
Tera-Gel Shampoo	Geritrex LLC	2016-01-19	HUMAN OTC DRUG LABEL	1