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 26 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acne buster star patch 140 patches - Tea Tree Extract and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.a94c69ee-70e9-448b-aa8a-556fcbd638852025-08-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC098e0fcf-7640-e40a-e063-6394a90ac1ee2025-07-28WarningsExact identifier
application number: M006
Clean and Clear Acne Exfoliating CleanserSALICYLIC ACIDKenvue Brands LLC09a07037-4085-ee0a-e063-6394a90aa7142025-07-28WarningsExact identifier
application number: M006
The Inkey List 360 Acne Clearing SerumSALICYLIC ACIDBrand Evangelists for Beauty Limitede5c0e866-4dd8-43d0-abaf-2e2351eb57c72025-07-25WarningsExact identifier
application number: M006
RoyceDerm Sulfur Soap.SULFURRoyceDerm LLC3a323a77-eff4-973f-e063-6394a90a02a02025-07-18WarningsExact identifier
application number: M006
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incfd92c669-997e-4eea-b883-fe3486b83f312025-07-15WarningsExact identifier
application number: M006
Blemish Blitz Emergency Acne SerumSALICYLIC ACIDGuangdong Joyan Biological Technology Co.,Ltd397a910a-c0ca-f5cb-e063-6394a90a3b9e2025-07-09WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
application number: M006
La Roche Posay Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc4795cc87-c663-4702-b65d-ce85203f12582025-07-08WarningsExact identifier
application number: M006
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC06804b81-db22-12ec-e063-6294a90a28e12025-07-07WarningsExact identifier
application number: M006
CeraVe Acne Clay-to-Foam CleanserSALICYLIC ACIDLOreal USA Products Inc3c4c2f52-0d37-4a3b-9a8d-2d54574b58d22025-06-26WarningsExact identifier
application number: M006
Freshiny Facial Cleanser Acne TreatmentSALICYLIC ACIDGuangdong Bawei Biotechnology Corporation4afe3a7e-8119-432a-b56a-34664d9b5a122025-06-24WarningsExact identifier
application number: M006
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact 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