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 15 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty Anti-DandruffPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyd21cbfda-17de-b17c-e053-2995a90a33992025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Scalp RestorePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyecfd66a4-81f4-3463-e053-2a95a90a18b12025-12-18WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean with Vitamin EPYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyecfde5bc-6100-d00c-e053-2995a90ac5dc2025-12-18WarningsExact identifier
application number: M032
Royal Oils by Head and Shoulders Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company1aa02661-4381-4f01-e063-6294a90aec622025-12-18WarningsExact identifier
application number: M032
AVEYA BIOTIN HAIR GROWTHBIOTINGuangdong Aimu Biological Technology Co., Ltd460fff55-728a-9c3a-e063-6394a90a31882025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Men Advanced Series Refreshing MentholPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7c4dacd2-d6aa-24c2-e053-2a91aa0a8c142025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Coconut DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1500e-b278-140a-e053-2991aa0ae6f22025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company9029d795-12f3-7048-e053-2a95a90a21852025-12-16WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Companyb69c4d1f-379f-be92-e053-2995a90ab7ad2025-12-16WarningsExact identifier
application number: M032
MOISTURIZING DANDRUFF 1% Pyrithione ZincPYRITHIONE ZINCBentley Laboratories, LLCc38b3a45-87f4-4121-8ae6-0a20f7c16c722025-12-15WarningsExact identifier
application number: M032
PS-2896 Hydrocortisone Cream 1%, 0.9gPS-2896 HYDROCORTISONE CREAM 1%, 0.9GProStat First Aid LLC0074e7bf-8c62-a5a7-e063-6394a90a63fc2025-12-15WarningsExact identifier
application number: M032
Hydrocortisone 1%HYDROCORTISONE 1%ProStat First Aid LLCf707bda4-074a-6406-e053-6394a90a7ae12025-12-15WarningsExact identifier
application number: M032
Hydrocortisone Cream 1%HYDROCORTISONE CREAM 1%Front Line Safety0f4ede34-7e70-789e-e063-6394a90a72a42025-12-15WarningsExact identifier
application number: M032
Dermgentle Seborrheic Face CreamPYRITHIONE ZINCDermgentle LLC45232668-6953-80a0-e063-6294a90a6e4b2025-12-12WarningsExact identifier
application number: M032
Kadason MedicatedSALICYLIC ACIDYs Pharma Inc.f425408c-95b1-409f-b64f-2e9f2f3310a02025-12-10WarningsExact identifier
application number: M032
Zinc PyrithioneZINC PYRITHIONEHarry's Inc.a6fdb13b-7943-3ae9-e053-2995a90a9db52025-12-08WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INCbf7b2339-20a4-4bab-b82f-6e28ff5187cb2025-12-08WarningsExact identifier
application number: M032
therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARGOODSENSE72ab0e6b-72a5-4e8a-af44-963251b0641f2025-12-08WarningsExact identifier
application number: M032
Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC5ccd409b-a81f-41bc-b986-bc7c0cc643fd2025-12-08WarningsExact identifier
application number: M032
Gold Bond Psoriasis Relief Medicated Multi-SymptomSALICYLIC ACIDGold Bond Co LLC5949a2e4-9169-4fca-aabb-b18dd1bc298b2025-12-04WarningsExact 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