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 38 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact identifier
application number: M006
Rush Salicylc Acid Complexion PadsSALICYLIC ACIDG.S. COSMECEUTICAL USA, INC.e9c3c3aa-e0e0-45aa-b97c-dc211e2f62b12024-11-26WarningsExact identifier
application number: M006
EVEN BETTER CLINICAL ACNE SOLUTIONSSALICYLIC ACIDCLINIQUE LABORATORIES LLC02e22431-ae2f-1f42-e063-6394a90aa3af2024-11-25WarningsExact identifier
application number: M006
Oxy Hydrating Anti-Blemish Body WashOXY HYDRATING ANTI-BLEMISH BODY WASHThe Mentholatum Company21b64a3f-2c90-1c1a-e063-6294a90a0ea02024-11-23WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLCf1d1053e-d863-4f02-9339-843d3d3e630e2024-11-20WarningsExact identifier
application number: M006
Equate Acne Wash Acne medicationBENZOYL PEROXIDEWal-Mart Stores, Inc.3c108488-dfaf-447c-ba26-15fd7cf677612024-11-18WarningsExact identifier
application number: M006
ACNE solutions CLARIFYINGSALICYLIC ACIDCLINIQUE LABORATORIES LLCdc1b2e2e-0e13-4029-bdac-44adb70492fd2024-11-18WarningsExact identifier
application number: M006
Meijer Maximum Strength Foaming Acne Face Wash Acne MedicationBENZOYL PEROXIDEMeijer Distribution, Inc4cfbaa79-ee6c-4946-8f8c-cda71b7a80fd2024-11-15WarningsExact identifier
application number: M006
amazon basics acne blackhead clearing scrub Acne TreatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC8e129137-85c6-423d-936e-4266988506a22024-11-15WarningsExact 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