RevitaDERM PSORIASIS

Product NDC: 63347-112
11-digit product format: 633470112
Labeler code: 63347
Product ID: 63347-112_52aacff7-6265-4446-9dd0-dfef99dd4785
Type: HUMAN OTC DRUG
Nonproprietary name: COAL TAR
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-11-01
Substance: COAL TAR
Active strength: 2 mg/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	63347-112		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63347-112	63347-112-01	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: RevitaDERM PSORIASIS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COAL TAR	2 mg/100mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317080	Internal RxNorm lookup
1297944	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
06ad14d3-4ff4-4283-8197-8626aad3b8d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63347-112-01	2022-02-18	C162847	48780-1	d6a99b39-a091-a426-e053-dadaa90af4c2	06ad14d3-4ff4-4283-8197-8626aad3b8d0
63347-112-01	2022-01-28	C162847	48780-1	d6a99b39-a091-a426-e053-dadaa90af4c2	06ad14d3-4ff4-4283-8197-8626aad3b8d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63347-112-01	RevitaDERM PSORIASIS	118 mL in 1 JAR	OINTMENT	118		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COAL TAR	ACTIVE INGREDIENT	R533ESO2EC	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
COAL TAR	ACTIVE MOIETY	R533ESO2EC	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
ALOE	INACTIVE INGREDIENT	V5VD430YW9	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
HYDROCORTISONE	INACTIVE INGREDIENT	WI4X0X7BPJ	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
SILVER	INACTIVE INGREDIENT	3M4G523W1G	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63347-112	REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231222_06ad14d3-4ff4-4283-8197-8626aad3b8d0.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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Classic Clean Dandruff	PYRITHIONE ZINC	CARDINAL HEALTH 110, LLC. DBA LEADER	5b22537d-d09c-5bd6-e063-6294a90a48ff	2026-09-10	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cc726c2-3747-6dbf-e063-6294a90a789f	2026-09-09	Warnings	Exact identifier application number: M032
Leader Maximum Strength Therapeutic Dandruff	SALICYLIC ACID	CARDINAL HEALTH 110, LLC. DBA LEADER	5afb2260-5b50-de95-e063-6394a90a5a47	2026-09-08	Warnings	Exact identifier application number: M032
ANTI-DANDRUFF	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	5ac93feb-eb6d-7563-e063-6294a90ad2e0	2026-09-05	Warnings	Exact identifier application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUM	SELENIUM SULFIDE SALICYLIC ACID	Guangzhou Liyan Cosmetics Technology Co., Ltd.	5aaeddff-72f9-3687-e063-6394a90ae5dc	2026-09-04	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Restore Nourishing Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	5a834d00-cc79-1a8e-e063-6294a90ab245	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-Shampoo	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a84c545-4570-b078-e063-6394a90a8c5a	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Purify Volumizing	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a8627ec-cfd8-d0f6-e063-6394a90ab488	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Soothe Cooling	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a87ed71-87e7-a7b7-e063-6294a90ac897	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Restore Nourishing	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	5a8a42d2-8610-1dfb-e063-6294a90abc7a	2026-09-02	Warnings	Exact identifier application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit	5% MINOXIDIL HAIR GROWTH KIT	Beijing Sea Heart International Science And Technology Co.,Ltd.	3b34f263-1232-4bb9-e063-6294a90a494d	2026-08-27	Warnings	Exact identifier application number: M032
SMOOTH AND SOFT DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	9e235139-07a2-469a-8601-db69379ce347	2026-08-24	Warnings	Exact identifier application number: M032
ITCHY SCALP RELIEF DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	634019c2-03a3-4fed-939e-6f9a50ddea7b	2026-08-24	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b4f9e3-c241-6a70-e063-6294a90a364f	2026-08-23	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b52a52-dab0-87b5-e063-6294a90a0596	2026-08-23	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b67ce0-3546-c18a-e063-6394a90ae50a	2026-08-23	Warnings	Exact identifier application number: M032
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	599f2cce-0c27-d425-e063-6394a90a1565	2026-08-22	Warnings	Exact identifier application number: M032
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	59a0a062-92d1-210a-e063-6394a90a9bf9	2026-08-22	Warnings	Exact identifier application number: M032
Ouai Anti-Dandruff	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5990c45f-f653-b403-e063-6394a90a329d	2026-08-21	Warnings	Exact identifier application number: M032
Dermatology Psoriasis Cream	COAL TAR	G.M.J Natural Products, Inc.	96cc5455-f3b8-4ded-a158-5de209d7bf0d	2026-08-21	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
317080	coal tar 2 % Topical Ointment	PSN	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
1297944	RevitaDERM PSORIASIS 2 % Topical Ointment	PSN	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
1297944	coal tar 0.02 MG/MG Topical Ointment [Revitaderm Psoriasis]	SBD	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
317080	coal tar 0.02 MG/MG Topical Ointment	SCD	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
317080	crude coal tar 2 % (coal tar solution 10 % ) Topical Ointment	SY	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
1297944	Revitaderm Psoriasis (coal tar 2 % ) Topical Ointment	SY	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4
1297944	Revitaderm Psoriasis 0.02 MG/MG Topical Ointment	SY	06ad14d3-4ff4-4283-8197-8626aad3b8d0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63347-112-01	63347011201	118 mL in 1 JAR (63347-112-01)	118 ml	2011-11-01	0000-00-00	No	No	Current