FDA.reportPublic FDA data

Family Wellness Therapeutic Tplus PLUS Dandruff

Product NDC
55319-485
11-digit product format
553190485
Labeler code
55319
Product ID
55319-485_bfb9fb31-f938-4810-be32-2a0e70e98b98
Type
HUMAN OTC DRUG
Nonproprietary name
COAL TAR
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
FAMILY DOLLAR SERVICES INC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
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
Family Wellness Therapeutic Tplus PLUS Dandruff
Brand name suffix
Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COAL TAR5 mg/mL

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46471dfa-2322-464f-8d00-bf49d8eb4e18Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-485-01Family Wellness Therapeutic Tplus PLUS DandruffAnti-dandruff, anti-seborrheic dermatitis, anti-psoriasis251 mL in 1 BOTTLESHAMPOO2514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-485FAMILY WELLNESS THERAPEUTIC TPLUS PLUS DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS (COAL TAR) SHAMPOO [FAMILY DOLLAR SERVICES INC]2Current NDC, 1 package rows20241023_46471dfa-2322-464f-8d00-bf49d8eb4e18.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 2 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a03d4bb-72e6-cc9f-e063-6394a90ae19f2026-08-01WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0505a6-77ca-c56e-e063-6394a90aea6f2026-08-01WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0521cd-2b9e-e02c-e063-6394a90a5f022026-08-01WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a054179-b0d7-3a0f-e063-6294a90a62092026-08-01WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC57425b1a-4cf3-b133-e063-6394a90a84f52026-07-23WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .Shampoo.SALICYLIC ACID 3%RoyceDerm LLC5743f813-57f7-f544-e063-6294a90ad3b82026-07-23WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309381coal tar 0.5 % Medicated ShampooPSN46471dfa-2322-464f-8d00-bf49d8eb4e184
309381coal tar 5 MG/ML Medicated ShampooSCD46471dfa-2322-464f-8d00-bf49d8eb4e184
309381coal tar 0.5 % Medicated ShampooSY46471dfa-2322-464f-8d00-bf49d8eb4e184
309381crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated ShampooSY46471dfa-2322-464f-8d00-bf49d8eb4e184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-485-0155319048501251 mL in 1 BOTTLE (55319-485-01) 251 ml2024-05-20NoNoCurrent