FDA.reportPublic FDA data

Pete and Pedro Control Anti Itch Dandruff

Product NDC
84503-508
11-digit product format
845030508
Labeler code
84503
Product ID
84503-508_1c403c65-8b3f-5f3c-e063-6394a90a487b
Type
HUMAN OTC DRUG
Nonproprietary name
COAL TAR
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
PETE AND PEDRO LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-25
Substance
COAL TAR
Active strength
62.5 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
Pete and Pedro Control Anti Itch Dandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COAL TAR62.5 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
34ec83c1-31b9-4ecc-8bd2-898fd85364baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84503-508-00Pete and Pedro Control Anti Itch Dandruff236 mL in 1 BOTTLESHAMPOO2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84503-508PETE AND PEDRO CONTROL ANTI ITCH DANDRUFF (COAL TAR) SHAMPOO [PETE AND PEDRO LLC]1Current NDC, 1 package rows20240704_34ec83c1-31b9-4ecc-8bd2-898fd85364ba.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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309381coal tar 0.5 % Medicated ShampooPSN34ec83c1-31b9-4ecc-8bd2-898fd85364ba1
309381coal tar 5 MG/ML Medicated ShampooSCD34ec83c1-31b9-4ecc-8bd2-898fd85364ba1
309381coal tar 0.5 % Medicated ShampooSY34ec83c1-31b9-4ecc-8bd2-898fd85364ba1
309381crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated ShampooSY34ec83c1-31b9-4ecc-8bd2-898fd85364ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84503-508-0084503050800236 mL in 1 BOTTLE (84503-508-00) 236 ml2024-06-25NoNoCurrent