FDA.reportPublic FDA data

Hermon Folliculitis Shampoo.

Product NDC
85398-009
Requested package NDC
85398-009-01
11-digit product format
853980009
Labeler code
85398
Product ID
85398-009_3c5f7caa-a4b0-2574-e063-6394a90a7507
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid 2%
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Beautivity LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-31
Substance
SALICYLIC ACID
Active strength
8 g/400mL
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
Hermon Folliculitis Shampoo.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID8 g/400mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205104Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c5f7caa-a4af-2574-e063-6394a90a7507Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-009-01Hermon Folliculitis Shampoo.400 mL in 1 BOTTLESHAMPOO4001

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 22 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c6289a3-2f09-c094-e063-6394a90a81f92025-01-23WarningsExact identifier
application number: M032
Tuymec Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOGuangzhou Zanming Trading Co., Ltd.2c62d04e-dcb6-a33e-e063-6394a90a2e8e2025-01-23WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARChain Drug Marketing Association, Inc.2bea5414-c7bc-d010-e063-6294a90aa1382025-01-17WarningsExact identifier
application number: M032
Meijer Medicated Selenium Sulfide Anti-DandruffSELENIUM SULFIDEMeijer Distribution, Inc41b563c6-5df6-4ead-bddf-a69a07970ea02025-01-14WarningsExact identifier
application number: M032
D-COL Personal Hygiene Convenience kitPYRITHIONE ZINC AND CHLOROXYLENOLD-COL Inc273fcc6f-9c54-42b0-aa0c-9051457b13412025-01-14WarningsExact identifier
application number: M032
Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.f8767db7-e208-4ccc-85f7-789e281c7f262025-01-10WarningsExact identifier
application number: M032
Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.c759b347-bdfb-4ff5-a464-b40fa2efb8432025-01-10WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCWal-Mart Stores, Inc.d561e8d2-2761-422b-8f05-ac76d3a043eb2025-01-10WarningsExact identifier
application number: M032
Royal Oils by Head and Shoulders Sulfate Free Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd73ab807-027f-7581-e053-2995a90ada832025-01-08WarningsExact identifier
application number: M032
Head and Shoulders Supreme Color Protect ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86ac3037-9ff2-25ea-e053-2a91aa0a43e32025-01-08WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCe5702ac7-e680-ab4b-e053-2995a90ad4422025-01-01WarningsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLCabaf1c64-1c4d-481a-9872-b64fcf82cc632025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp CareSALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bdad4d-d499-70a9-e053-2a95a90a5cd92025-01-01WarningsExact identifier
application number: M032
Dr. Groot Anti-dandruff Scalp Care 2 in 1SALICYLIC ACIDTAI GUK PHARM. CO., LTDe8bf3852-e963-7a48-e053-2995a90a5aa12025-01-01WarningsExact identifier
application number: M032
American CrewPYRITHIONE ZINCRevlon Consumer Products Corp9566b567-90be-4803-b940-e6a91750778f2024-12-30WarningsExact identifier
application number: M032
Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff TreatmentSALICYLIC ACIDL'Oreal USA Products Inc.d72688ed-d153-4eed-988f-5386eb68559d2024-12-30WarningsExact identifier
application number: M032
Dermaharmony Seborrheic DermatitisPYRITHIONE ZINCD3 Development, Inc.8d81521d-9e6f-1acf-e053-2995a90a92422024-12-20WarningsExact identifier
application number: M032
Dermaharmony Sulfur and Salicylic AcidSALICYLIC ACID, SULFURD3 Development, Inc.a1c61da2-7e7a-430a-e053-2995a90ad5942024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintSALICYLIC ACID, SULFURD3 Development, Inc.af7060a9-986c-500e-e053-2a95a90a64382024-12-20WarningsExact identifier
application number: M032
Dermaharmony Bar PeppermintPYRITHIONE ZINCD3 Development, Inc.a19b74b0-88c6-6897-e053-2a95a90a73092024-12-20WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205104salicylic acid 2 % Medicated ShampooPSN3c5f7caa-a4af-2574-e063-6394a90a75071
205104salicylic acid 20 MG/ML Medicated ShampooSCD3c5f7caa-a4af-2574-e063-6394a90a75071
205104salicylic acid 2 % Medicated ConditionerSY3c5f7caa-a4af-2574-e063-6394a90a75071
205104salicylic acid 2 % Medicated ShampooSY3c5f7caa-a4af-2574-e063-6394a90a75071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-009-0185398000901400 mL in 1 BOTTLE (85398-009-01) 400 ml2025-08-31NoNoCurrent