Anti-Dandruff

Product NDC: 49348-602
11-digit product format: 493480602
Labeler code: 49348
Product ID: 49348-602_31cae232-c0a7-4135-9ef1-7b2db7b494ad
Type: HUMAN OTC DRUG
Nonproprietary name: Coal Tar
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Strategic Sourcing Services LLC
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2005-05-21
Marketing end: 0000-00-00
Substance: COAL TAR
Active strength: 25 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49348-602		D	Discontinued by firm		2026-10-05
excluded package	package	49348-602	49348-602-47	D	Discontinued by firm		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 1 · 10 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	49348-602-47	`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	49348-602-47	`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	49348-602-47	`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	49348-602-47	`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	49348-602-47	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-602-47	ML - Milliliter	49348-602	47a66d56-5a04-4f02-b4c8-dc6d19bb79f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COAL TAR	ACTIVE INGREDIENT	R533ESO2EC	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
COAL TAR	ACTIVE MOIETY	R533ESO2EC	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
LAURETH-4	INACTIVE INGREDIENT	6HQ855798J	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTI-DANDRUFF (COAL TAR) SHAMPOO [MCKESSON]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-602-47	49348060247	251 mL in 1 BOTTLE, PLASTIC (49348-602-47)	251 ml	2005-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SunMark 205.004/205AH Coal Tar Shampoo	Strategic Sourcing Services LLC \| Consumer Product Partners, LLC	2024-09-27	HUMAN OTC DRUG LABEL	16