Therapeutic Hydrogel

Product NDC
78863-1090
11-digit product format
788631090
Labeler code
78863
Product ID
78863-1090_527a729b-d26e-4543-bb3f-3b82e116b0a1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Noon Aesthetics M.R. Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
SALICYLIC ACID
Active strength
1 g/50g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Therapeutic Hydrogel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1 g/50g

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
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cfe76456-0a4c-4dd8-b060-af9d109fb9b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-1090-1Therapeutic Hydrogel50 g in 1 BOTTLE, DISPENSINGCREAM504
78863-1090-1Therapeutic Hydrogel1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78863-1090THERAPEUTIC HYDROGEL (SALICYLIC ACID) CREAM [NOON AESTHETICS M.R. LTD]3Current NDC, Legacy NDC, 2 package rows20240125_cfe76456-0a4c-4dd8-b060-af9d109fb9b9.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 22 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPPORT SERUM FORTIFIEDSULFURZENMED Raging Creations Ltd.26e5777d-4ce2-458c-90f1-4c23c7b571ed2025-11-10WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Spot GelSALICYLIC ACIDTHG Beauty USA LLC1f92122d-4873-8c1a-e063-6294a90a1c3b2025-11-07WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Clearing TreatmentSALICYLIC ACIDTHG Beauty USA LLC1f4108da-c83b-4b1d-e063-6294a90abfd72025-11-07WarningsExact identifier
application number: M006
e.l.f Skin Acne-Treating Body MistSALICYLIC ACIDe.l.f. Cosmetics, Incf575b71f-d2bf-7469-e053-2995a90a02eb2025-11-07WarningsExact identifier
application number: M006
Naturium Benzoyl Peroxide Cleanser 5%BENZOYL PEROXIDEe.l.f. Cosmetics, Inc0a278590-e98b-7cab-e063-6394a90a4d0e2025-11-07WarningsExact identifier
application number: M006
Clear Smart Charcoal Blackhead ScrubSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.5e13ccf6-f66a-475f-aaf8-6609369c36a82025-11-05WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories54ebb0ba-e32c-4b8e-8427-b947ca6441502025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories42e9bea8-e840-4163-929e-967baf5f2f902025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories1ac05b1f-d508-4e9b-bef1-22e522ad740f2025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDERugby Laboratories5af89ec6-0f4a-451a-8a45-5194115dc8282025-11-03WarningsExact identifier
application number: M006
AOSORW Folliculitis and Acne Treatment CreamFOLLICULITIS AND ACNE TREATMENT CREAMSpineStatus LLC3a07f7dd-8159-46b1-e063-6294a90a774b2025-11-03WarningsExact identifier
application number: M006
Mild By Nature ACNE FOAMING CLEANSERACNE FOAMING CLEANSERIHerb, LLC42b6187e-ef98-7be5-e063-6394a90a5e0f2025-11-03WarningsExact identifier
application number: M006
Dermacleanse Acne Spot TreatmentSALICYLIC ACIDZENMED Raging Creations Ltd.3f691959-a37b-430c-8135-27f086c650562025-11-03WarningsExact identifier
application number: M006
Perricone MD Acne Relief Gentle and Soothing CleanserSALICYLIC ACIDTHG Beauty USA LLC1f3d93f0-3a53-d6f0-e063-6394a90a2aff2025-10-31WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21eafafe-18ea-08d3-e063-6294a90abb852025-10-30WarningsExact identifier
application number: M006
OXY Deep Pore Cleansing PadsSALICYLIC ACIDThe Mentholatum Companyedaf76d4-1e9b-4397-96af-25a5252675e32025-10-29WarningsExact identifier
application number: M006
Perricone MD Acne Relief Gentle Exfoliating Toner Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21ea9a55-0a1f-47f7-e063-6294a90aa2692025-10-28WarningsExact identifier
application number: M006
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 20 MG/ML Topical CreamSCDcfe76456-0a4c-4dd8-b060-af9d109fb9b94
317152salicylic acid 2 % Topical CreamSYcfe76456-0a4c-4dd8-b060-af9d109fb9b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78863-1090-1788631090011 BOTTLE, DISPENSING in 1 CARTON (78863-1090-1) / 50 g in 1 BOTTLE, DISPENSING2020-05-010000-00-00NoNoCurrent