FDA.reportPublic FDA data

Prosoria Medicated

Product NDC
71573-121
11-digit product format
715730121
Labeler code
71573
Product ID
71573-121_6fec05aa-5d44-4667-98f7-c61ac09c6307
Type
HUMAN OTC DRUG
Nonproprietary name
Selenium Sulfide
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
Nuvothera, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
SELENIUM SULFIDE
Active strength
1.77 g/177mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prosoria Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE1.77 g/177mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z69D9E381QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204642Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44eaaeb0-1400-4697-85d0-e8c2282c1cbaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71573-121-12Prosoria Medicated177 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71573-121PROSORIA MEDICATED (SELENIUM SULFIDE) LOTION/SHAMPOO [NUVOTHERA, INC.]2Current NDC, Legacy NDC, 1 package rows20240112_44eaaeb0-1400-4697-85d0-e8c2282c1cba.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC9e235139-07a2-469a-8601-db69379ce3472026-08-24WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC634019c2-03a3-4fed-939e-6f9a50ddea7b2026-08-24WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b4f9e3-c241-6a70-e063-6294a90a364f2026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b52a52-dab0-87b5-e063-6294a90a05962026-08-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.59b67ce0-3546-c18a-e063-6394a90ae50a2026-08-23WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.599f2cce-0c27-d425-e063-6394a90a15652026-08-22WarningsExact identifier
application number: M032
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.59a0a062-92d1-210a-e063-6394a90a9bf92026-08-22WarningsExact identifier
application number: M032
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
application number: M032
Dermatology Psoriasis CreamCOAL TARG.M.J Natural Products, Inc.96cc5455-f3b8-4ded-a158-5de209d7bf0d2026-08-21WarningsExact identifier
application number: M032
apgwgzminoxidil5%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd596d0b43-5cb1-be25-e063-6394a90abbed2026-08-19WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC280391ce-ccd9-4b39-95a2-93e7fca84ccc2026-08-18WarningsExact identifier
application number: M032
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
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204642selenium sulfide 1 % Medicated ShampooPSN44eaaeb0-1400-4697-85d0-e8c2282c1cba2
204642selenium sulfide 10 MG/ML Medicated ShampooSCD44eaaeb0-1400-4697-85d0-e8c2282c1cba2
204642selenium sulfide 1 % Lotion ShampooSY44eaaeb0-1400-4697-85d0-e8c2282c1cba2
204642selenium sulfide 1 % Medicated ShampooSY44eaaeb0-1400-4697-85d0-e8c2282c1cba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71573-121-1271573012112177 mL in 1 BOTTLE, PLASTIC (71573-121-12) 177 ml2022-04-010000-00-00NoNoCurrent