FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct63347-112EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63347-11263347-112-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
COAL TAR2 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R533ESO2ECInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317080Internal RxNorm lookup
1297944Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06ad14d3-4ff4-4283-8197-8626aad3b8d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-112-012022-02-18C16284748780-1d6a99b39-a091-a426-e053-dadaa90af4c206ad14d3-4ff4-4283-8197-8626aad3b8d0
63347-112-012022-01-28C16284748780-1d6a99b39-a091-a426-e053-dadaa90af4c206ad14d3-4ff4-4283-8197-8626aad3b8d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-112-01RevitaDERM PSORIASIS118 mL in 1 JAROINTMENT1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAL TARACTIVE INGREDIENTR533ESO2ECREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
COAL TARACTIVE MOIETYR533ESO2ECREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
ALOEINACTIVE INGREDIENTV5VD430YW9REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
HYDROCORTISONEINACTIVE INGREDIENTWI4X0X7BPJREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
SILVERINACTIVE INGREDIENT3M4G523W1GREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEREVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-112REVITADERM PSORIASIS (COAL TAR) OINTMENT [BLAINE LABS INC.]4Current NDC, Legacy NDC, 1 package rows20231222_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 3 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317080coal tar 2 % Topical OintmentPSN06ad14d3-4ff4-4283-8197-8626aad3b8d04
1297944RevitaDERM PSORIASIS 2 % Topical OintmentPSN06ad14d3-4ff4-4283-8197-8626aad3b8d04
1297944coal tar 0.02 MG/MG Topical Ointment [Revitaderm Psoriasis]SBD06ad14d3-4ff4-4283-8197-8626aad3b8d04
317080coal tar 0.02 MG/MG Topical OintmentSCD06ad14d3-4ff4-4283-8197-8626aad3b8d04
317080crude coal tar 2 % (coal tar solution 10 % ) Topical OintmentSY06ad14d3-4ff4-4283-8197-8626aad3b8d04
1297944Revitaderm Psoriasis (coal tar 2 % ) Topical OintmentSY06ad14d3-4ff4-4283-8197-8626aad3b8d04
1297944Revitaderm Psoriasis 0.02 MG/MG Topical OintmentSY06ad14d3-4ff4-4283-8197-8626aad3b8d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-112-0163347011201118 mL in 1 JAR (63347-112-01) 118 ml2011-11-010000-00-00NoNoCurrent