X-FOLATE

Product NDC: 59279-516
Requested package NDC: 59279-516-08
11-digit product format: 592790516
Labeler code: 59279
Product ID: 59279-516_d580d658-6540-39fe-e053-2a95a90a8830
Type: HUMAN OTC DRUG
Nonproprietary name: COAL TAR
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Mediceutical Laboratories, LTD
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-03-11
Marketing end: 0000-00-00
Substance: COAL TAR
Active strength: 5 g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59279-516	59279-516-08	I	Inactivated by FDA		2026-10-20

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 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59279-516-08	2024-01-30	C162847	48780-1	1030e365-0260-111a-e063-dadaa90a10e2	Mediceutical Laboratories - X-FOLATE PLUS (59279-516)
59279-516-33	2024-01-30	C162847	48780-1	1030e365-0260-111a-e063-dadaa90a10e2	Mediceutical Laboratories - X-FOLATE PLUS (59279-516)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59279-516-08	X-FOLATEPLUS	250 mL in 1 BOTTLE	SHAMPOO	250		4
59279-516-33	X-FOLATEPLUS	1000 mL in 1 BOTTLE	SHAMPOO	1000		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59279-516	X-FOLATE PLUS (COAL TAR) SHAMPOO [MEDICEUTICAL LABORATORIES, LTD]	4	Legacy NDC, 2 package rows	20220114_1797d6d4-f5d8-4178-b7ec-d64d97c6255f.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
204681	coal tar 5 % Medicated Shampoo	PSN	1797d6d4-f5d8-4178-b7ec-d64d97c6255f	4
204681	coal tar 50 MG/ML Medicated Shampoo	SCD	1797d6d4-f5d8-4178-b7ec-d64d97c6255f	4
204681	coal tar 5 % Medicated Shampoo	SY	1797d6d4-f5d8-4178-b7ec-d64d97c6255f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59279-516-08	59279051608	250 mL in 1 BOTTLE (59279-516-08)	250 ml	2021-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mediceutical Laboratories - X-FOLATE PLUS (59279-516)	Mediceutical Laboratories, LTD	2022-01-13	HUMAN OTC DRUG LABEL	4