Thera-Gel

Product NDC: 0904-5259
Requested package NDC: 0904-5259-44
11-digit product format: 009045259
Labeler code: 0904
Product ID: 0904-5259_0ee62461-8b30-435e-8069-8947df75f89a
Type: HUMAN OTC DRUG
Nonproprietary name: Coal Tar
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-05-18
Substance: COAL TAR
Active strength: 5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Thera-Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COAL TAR	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R533ESO2EC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309381	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1c18fde9-d39b-4339-8f62-3f352d450291	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-5259-44	Thera-Gel	251 mL in 1 BOTTLE, PLASTIC	SHAMPOO	251		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5259-44	ML - Milliliter	0904-5259	d98cc74c-1c8d-4a0f-80f8-ffaf22ce5e7e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Coal Tar	ACTIVE INGREDIENT	R533ESO2EC	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Coal Tar	ACTIVE MOIETY	R533ESO2EC	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Cocamidopropyl Betaine	INACTIVE INGREDIENT	5OCF3O11KX	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Laureth-4	INACTIVE INGREDIENT	6HQ855798J	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5259	MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 1 package rows	20240531_1c18fde9-d39b-4339-8f62-3f352d450291.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 17 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaZinc	PYRITHIONE ZINC	WynnPharm Inc	e73010ae-291d-6adf-e053-2a95a90a8aea	2025-11-14	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7bbd2559-4aba-9f18-e053-2991aa0a152e	2025-11-13	Warnings	Exact identifier application number: M032
Divine Dandrene 1%	ZINC PYRITHIONE	DS Healthcare Group, Inc.	ab605699-4090-45a3-882f-44379fe2a82e	2025-11-11	Warnings	Exact identifier application number: M032
Divine Dandrene 2%	ZINC PYRITHIONE	DS Healthcare Group, Inc.	54b0a610-dd15-4064-9feb-4d30b5e522ad	2025-11-11	Warnings	Exact identifier application number: M032
Dandrene Anti-Dandruff Conditioner	ZINC PYRITHIONE	DS Healthcare Group, Inc.	aed49bfe-e016-46ac-a025-81b47cc08147	2025-11-11	Warnings	Exact identifier application number: M032
Minoxidil hair growth serum	MINOXIDIL HAIR GROWTH SERUM	Jiashen International Trade Limited	26cc22be-30f6-03da-e063-6394a90aafe7	2025-11-09	Warnings	Exact identifier application number: M032
Sulfur 8 Kids Anti-Dandruff	PYRITHIONE ZINC	J. Strickland & Co.	89f4ecc8-7a49-42cb-b85d-71c9299e6712	2025-11-07	Warnings	Exact identifier application number: M032
Sulfur 8 Aqua Blue	PYRITHIONE ZINC	J. Strickland & Co.	cdcf3cea-4a5d-4b8b-b47d-3163f9837d16	2025-11-07	Warnings	Exact identifier application number: M032
Sulfur 8 Scalp Therapy Medicated Dandruff Control	PYRITHIONE ZINC	J. Strickland and Co.	96b26da0-d0d7-77ed-e053-2995a90a7a78	2025-11-07	Warnings	Exact identifier application number: M032
Shailee Psoriasis Treatment	SALICYLIC ACID	Foshan Sugar Max Cosmetics CO.,Ltd	02a71ce4-baf5-4231-afd6-21ef0b22e931	2025-11-05	Warnings	Exact identifier application number: M032
Sulfur 8 Kids Anti-Dandruff Hair and Scalp Conditioner	SULFUR	J. Strickland & Co.	8e9da3fd-701e-4354-bb00-ecd4dab48fa3	2025-11-03	Warnings	Exact identifier application number: M032
Denorex Severe Flakes Medicated Anti Dandruff	PYRITHIONE ZINC	Neoteric Cosmetics, Inc.	41ad0d3a-0704-44c9-e063-6394a90ad40d	2025-10-21	Warnings	Exact identifier application number: M032
Stay Minoxidil Hair Regrowth Treatment	MINOXIDIL 5%	HALORIA INC.	41b745d7-6947-ec24-e063-6294a90aa467	2025-10-21	Warnings	Exact identifier application number: M032
DERMOSCRIBE SEBORRHEIC DERMATITIS	SULFUR, SALICYLIC ACID, HYDROCORTISONE	DERMOSCRIBE PTY LTD	2b6bf90b-5d42-4c08-afee-56e13122285e	2025-10-17	Warnings	Exact identifier application number: M032
Shea Moisture	APPLE CIDER VINEGAR INSTANT SCALP REFRESH ANTI-DANDRUFF SPRAY	Conopco, Inc. d/b/a Unilever	414ab8ec-165c-21f8-e063-6294a90adc4f	2025-10-16	Warnings	Exact identifier application number: M032
Shea Moisture	APPLE CIDER VINEGAR ANTI-DANDRUFF LEAVE-IN	Conopco, Inc. d/b/a Unilever	414b7fd2-6a65-af39-e063-6394a90a00b8	2025-10-16	Warnings	Exact identifier application number: M032
Seacall Natural Cedarwood Oil	NATURAL CEDARWOOD OIL	Guangdong Quadrant Ecological Technology Co., Ltd.	1f4ebe4d-6e93-378c-e063-6394a90aec95	2025-10-15	Warnings	Exact identifier application number: M032
RemedyDandruffShampooTreatment	ACTIIV REMEDY DANDRUFF SHAMPOO TREATMENT	Naturich Cosmetique Labs	129fd043-6643-cc46-e063-6294a90a6eae	2025-10-08	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	40464e2d-f738-33ec-e063-6394a90a02c2	2025-10-03	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Clinical Strength Cooling Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	4046c345-e1ac-0ecc-e063-6294a90a59fa	2025-10-03	Warnings	Exact identifier application number: M032

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	1c18fde9-d39b-4339-8f62-3f352d450291	7
309381	coal tar 5 MG/ML Medicated Shampoo	SCD	1c18fde9-d39b-4339-8f62-3f352d450291	7
309381	coal tar 0.5 % Medicated Shampoo	SY	1c18fde9-d39b-4339-8f62-3f352d450291	7
309381	crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated Shampoo	SY	1c18fde9-d39b-4339-8f62-3f352d450291	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5259-44	00904525944	251 mL in 1 BOTTLE, PLASTIC (0904-5259-44)	251 ml	2010-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major ® Thera-Gel™ Therapeutic Anti-Dandruff	Major Pharmaceuticals \| Garcoa, Inc. \| Sigan America, LLC	2024-05-28	HUMAN OTC DRUG LABEL	7